EFFECT OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION IN ... proper1.pdf · EFFECT OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION IN THE MANAGEMENT OF POST INJECTION SCIATIC PAIN

EFFECT OF TRANSCUTANEOUS ELECTRICAL NERVE

STIMULATION IN THE MANAGEMENT OF POST INJECTION

SCIATIC PAIN

M.SC. PROJECT

BY

Okonkwo Uchenna Prosper

PG/M.SC/03/37331

Department of Medical Rehabilitation,

Faculty Health Sciences and Technology,

College of Medicine, University of Nigeria,

Enugu Campus, Enugu

Supervisor: Dr K. K. Agwu

June, 2009.

EFFECT OF TRANSCUTANEOUS ELECTRICAL NERVE

STIMULATION (TENS) IN THE MANAGEMENT OF POST

INJECTION SCIATIC PAIN

A DISSERTATATION

BY

OKONKWO UCHENNA PROSPER

REG. NO. PG/MSC/03/37331

DEPARTMENT OF MEDICAL REHABILITATION

UNIVERSITY OF NIGERIA, ENUGU

CAMPUS

MARCH, 2009

PROJECT SUPERVISOR, DR. K. K. AGWU

APPROVAL PAGE

NAME: OKONKWO UCHE PROSPER

DEGREE: MASTER OF SCIENCE (MSC) IN

MEDICAL REHABILITATION.

TITTLE OF DISSERTATION: THE EFFECT OF TRANSCUTANEOUS

ELECTRICAL NERVE STIMULATION

IN THE MANAGEMENT OF POST

INJECTION SCIATIC PAIN.

EXAMINERS COMMENTS:

1. HEAD OF DEPARTMENT: ------------------------------------------------

DR SAMUEL IBENEME

2. PROJECT SUPERVISOR:----------------------------------------------------

DR. K. K. AGWU

3. EXTERNAL EXAMINER: --------------------------------------------------

DR A.O.B. ADEGOKE

4. INTERNAL EXAMINER:----------------------------------------------------

PROF. ONYEMELUKWE

DATE APPROVED: ---------------------------------------------------------------

DEDICATIONS

This work is dedicated to the memory of my late father Mr okonkwo

Gabriel Nweke and my late brother Mr okonkwo Nnamdi Samuel for what

they stood for and represented while alive.

ACKNOWLEDGEMENT

I wish to thank Dr. E. C. Okoye, the former Dean, Faculty of Health Science

and Technology, University of Nigeria Enugu Campus (UNEC) and who was

my former supervisor for his numerous contributions to this project work. My

heartfelt thanks go to my current supervisor Dr K.K. Agwu for his fatherly

dispositions and wonderful advices towards that helped in concluding this

work. To Dr. Ibeneme Samuel (PT), the current Head of Department of

Medical Rehabilitation, UNEC, my appreciations of all his efforts that

contributed in making this work what it is today is indescribable. I am highly

indebted to Mr S. E. Igwe the former HOD of Department of Medical

Rehabilitation for his several contributions to this work, UNEC.

My special regards go to the lecturers in the Department of Medical

Rehabilitation, Nnamdi Azikiwe University Awka (NAUTH), Mr Umunna

Joseph (PT), Mr Maruf Fatai (PT) and Dr.Akosile (PT) for enhancing this

work technically. Furthermore, I am highly indebted to the statistical experts

Dr. S.E, Meludu, former Dean Faculty of Health Science and Technology and

Dr. Onyenekwe, Sub-Dean/ Lecturer Faculty of Health Science and

Technology, Nnamdi Azikiwe University Awka, who in their various

capacities facilitated the statistical analysis in this project work. I wish to

specially recognize Dr. S.E. Meludu who on several occasions allowed me to

even come to his house any time I encountered problem. My wonderful

colleague, Ihegihu E, Y (PT) equally deserves my commendations. To Dr M.

J. Nwankwo and Dr Afunne of NAUTH, Nnewi I say thank you. I am

indebted to the management of Landmark Physiotherapy Clinic, Nnewi for

making their patients available as subjects in this research study; I have

special regards to the members of staff of God‘s Favor Business center,

Nnewi for facilitating the typing and printing of this work.

I cannot forget the seventy two (72) patients who irrespective of individual

and collective inconveniencies kept to their treatment schedule. Their roles

have helped this researcher to contribute to the scientific body of knowledge.

My last thanks go to my darling wife, Mrs. Ifeyinwa Prosper Okonkwo, who

stood by me through out the period of this work. Her support not only uplifted

my spirit but gave me the needed momentum to execute this research work.

ABSTRACT

The aim of this study was to assess the impact of Transcutaneous Electrical

Nerve Stimulation (TENS) in the management of Post injection pain.

A total of 72-40 males and 32 females- patients comprising 40 test subjects

and 32 control subjects participated in this study. TENS alone was used on the

40 test subjects, 3 times a week, and one hour per session for the 10 weeks the

study lasted, while a sham TENS was applied on the 32 control subjects. The

wave form was typically asymmetrical biphasic with a zero net direct current

component. The pulse frequency rate was 1-5 Hz, pulse width was 150-

250µsec, while the amplitude was a strong, but comfortable rhythmic muscle

twitches. This study apart from being a single blind placebo test adopted a

cross-sectional experimental clinical trial-the participants were recruited as

they were available to participate in an experimental clinical procedure. These

participants were then randomly assigned to either group A or group B. The

data analysis was done with student t-test and percentages. The result revealed

that there was a statistically significant difference in pain intensity between

the test group and the control group (p<0.05).

TENS from this study had substantial reduction in pain intensity in patients

who presented with post injection sciatic pain secondary to intramuscular

injection. The percentage analysis of the performance of 40 test subjects who

participated in this study showed that 10 (25%) of the patients had their pain

relieved completely while 16 (40%) had some substantial relieve after the 10

weeks application of Transcutaneous Electrical Nerve Stimulation. The

implication of this is that 35% of the participants had no improvement at all

while 65% had from substantial relieve to zero reduction in their pain intensity

level.

The outcome of this research has proved that TENS can reduce significantly

patients Post Injection Sciatic pain and is being recommended as an adjunct in

the management of Post Injection sciatic pain because the result from this

study have confirmed that it does not guarantee 100% relieve of patients

symptoms.

TABLE OF CONTENTS

APPROVAL PAGE………………………………………………………………..I.

DEDICATIONS……………………………………………………………………ii.

ACKNOWLEDGEMENT…………………………………………………………iii.

ABSTRACT ………………………………………………………………………IV.

CHAPTER ONE

1.0 INTRODUCTION:

1.1 BACKGROUND OF STUDY …………………………………………….1-5

1.2 STATEMENT OF STUDY…………………………………………………5-6

1.3 AIMS OF STUDY…………………………………………………………..6.

1.4 REARCH QUESTION ………………………………………………………6

1.5 HYPOTHESES ...………………………………………………. ………..6-7.

1.6 .Clinical significance of study ………………………………………………7

1.7. Limitations of study ………………………………………………… ……..7

1.8 Delimitation ……………………………………………………………..... 8

CHAPTER TWO

2.0 Literature Review:

2.1 Sciatic Nerve Anatomy ……………………………………………… ..9-12

2.2 Sciatica and Sciatic Nerve ……………………………………………..12-13

2.3 Six leading Causes of Sciatica …………………………………………14-19

2.4 Different Types of Sciatica …………………………………………….. 19

2.5 Use of Sciatic Terminology ……………………………………………..19

2.6 Transcuteneous Electrical Nerve stimulation …………………………..22-23

2.7 TENS Theory…………………………………………………………..24-30

2.8 Pain Gate Theory ………………………………………………………….30

2.9 TENS Machine parameters………………………………………………...34

2.1.0 Mechanism of Action ………………………………………………………38

2.9.1 Traditional TENS……………………………………………………………39

2.9.2 Acupunture or Burst TENS…………………………………………………..39

2.9.3 Brief TENS ………………………………………………………………39-40

2.9.4 Burst TENS …………………………………………………………………40

2.9.5 Frequency Selection …………………………………………………………40

2.9.6 Stimulation Intensity…………………………………………………………41

2.9.7 Electrodes Placement ………………………………………………………..41

2.9.8 Precautions and Contraindications of TENS……………………………41-42

CHAPTER THREE

3.0 Methods and Procedure

3.1 Materials and Equipments of Study ……………………………………43

3.2 Research Design ………………………………………………………..43

3.3 Sampling Technique …………………………………………………….43

3.4 Sample Size ……………………………………………………………..43

3.5 Inclusion Criteria ……………………………………………………… 44

3.6 Clinical Evaluation of Patients …………………………………………45

3.7 Treatment Procedures …………………………………………………..45

3.8 TENS Mode……………………………………………………………..46

3.9 Duration of TENS Application…………………………………………50

3.1.0 Procedure for Data Collection ………………………………………….50

3.1.1 Procedure for data Analysis ……………………………………...51

CHAPTER FOUR

4.0 Results and Discussions

4.1 Results ……………………………………………………………….. 52-61

4.2 Hypothesis Testing………………………………………………….. . 62-64

4.3 Discussions …………………………………………………………….65-69

CHAPTER FIVE

5.0 Summary, Conclusions and Recommendations

5.0 Summary ………………………………………………………………..70

5.1 Conclusions ……………………………………………………………..73

5.1 Recommendations …………………………………………………….73-74

References……………………………………………………………...72-88

Appendix I

Appendix ii

Appendix iii

Appendix IV

Appendix v

Appendix VI

Approval Letter to Use Patients

Informed Consent

Ethical approval

LIST OF FIGURES

Figure 1: The route, the branches and motor supplies of Sciatic Nerve

Figure 2: Relationship between the piriformis syndrome and Sciatic

nerve.

Figure 3: The interplay between the large diameter (excitatory)

afferents and small diameter(inhibitory) afferents on the

transmission cell.

Figure 4: TENS Controls

Figure 5: Shows TENS with dual channel electrodes used in this

research

Figure 6: Shows electrodes placement during treatment1

Figure 7: Shows electrodes placement during treatment2

Figure 8: Shows electrodes placement during treatment3

LIST OF TABLES

Table 1: Baseline characteristics of the groups evaluated at the initial

assessment.

Table 2: Comparison of mean values for age, duration, baseline Visual

Analogue Scale scores for the experimental and control participants.

Table 3: Comparison of the Visual Analogue Scale scores between the

experimental and control participants at the second, fourth, sixth,

eignt and tenth weak of treatment.

Table 4: Comparison of the baseline visual Analogue Scale scores of

experimental participants and each of second, fourth, sixth, eight and

tenth weak.

Table 5: Comparison of the baseline Visual Analogue Scale scores of control

participants and each of the second, fourth,sixth,eight and tenth Week.

Table 6: Comparison of the baseline VAS of experimental participants and

each of the second, fourth, sixth, eigth and tenth week of treatment by

gender.

Table 7: Comparison of the baseline Visual Analogue Scale of control

participants and each of the second, fourth, sixth, eight and tenth

week of treatment by gender.

Table 8: Comparison of Visual Analogue scale scores of experimental and

control participants at each of the second, fourth, sixth, eigth and tenth

week of treatment by gender.

Table 9: Summary of experimental patients response to TENS application in

percentages

CHAPTER ONE

1.0 INTRODUCTION

1.1 Background of study.

Pain no matter how little or intense is a sign of abnormality; it depicts a symptom of an

underlying medical problem. It could equally signify the presence of a noxious agent that

causes temporal or prolonged irritation of the afferent nerve fibers: small diameter

myelinated fiber-group III afferents and small diameter unmyelinated fiber-group IV

afferents. It is defined as an unpleasant, sensory and emotional experience associated with

actual or potential tissue damage (IASP, 1979). Pain is the most demanding of all

symptoms of diseases and most people who seek medical treatment actually have pain as

complaint (Umunah, 2004) Pain is a subjective sensation that accompanies the activation of

nociceptors. These sensations are variable in quality and presentation and can have untold

effects on the physical and emotional well being of the subject. Pain sensation can range

from mild irritation to severe, intractable pain that can be beyond endurance (Wood, 1996).

There are varied causes and manifestations of pain and different medical options aimed at

alleviating it may include surgical and non-surgical methods. The results of surgical

approach or intervention in most cases are very disappointing. Studies indicate that long-

term benefits of surgery for pain relief are no greater than those offered by alternative

medicine (SNPM, 2005). The non-surgical management involves administration of

medicines, acupuncture, chiropractics, and physical therapy. One of the physical therapy

modalities used in this regard is Transcutaneous Electrical Nerve Stimulation (TENS).

The Sciatic nerve is the longest and the largest nerve in the body measuring three quarter

of an inch in diameter. The nerve has two main branches – the fibular and tibial nerves. The

fibular nerve has its origin at L4-L5 and S1-S2 while the tibial nerve has its origin at L4-L5

and S1-S3 (Eidelson, 2005). A branch of the sacral plexus L4-S3 transverse the greater

sciatic foramina, below the piriformis. The fibular component, however, may pierce the

piriformis (or even emerge superior to that muscle), in which case it remains separate. The

sciatic nerve descends under cover of the gluteus maximus and runs along the middle of the

posterior thigh. In terms of surface anatomy, the sciatic nerve leaves the pelvis a little more

than a third of the way along a line from the posterior superior iliac spine to the ischial

tuberosity. It then descends about halfway between the ischial tuberosity and the greater

trochanter. It continues vertically downwards in the midline of the posterior aspect of the

thigh. The nerve ends at the popliteal fossa by dividing into the tibial and common fibular

nerve (Eidelson, 2005).

Post injection sciatic pain is a peculiar type of pain that stems from a injury to the sciatic

nerve and its clinical presentations mimics that of sciatica only that its pain stems from the

injection site downward. Due to its sensitive anatomical location and its supply of most of

the muscles of the lower limbs the sciatic nerve is often times directly or indirectly

traumatized during the process of administering intramuscular injection or direct pressure

from abscess formation. Sciatic nerve could also be irritated by some other medical

problems such as herniated disc (Ulrich, 2006). The consequence of these on the body

system is the generation of painful sensation that traverse partially or completely the route

of the sciatic nerve and is known as sciatica. Post injection sciatic pain has an intriguing

nature and could presents with the symptoms of pain, weakness, numbness and other

discomfort along the sciatic nerve. It can afflict adults and non adult from time to time and

subsequently continues to interfere with the activities of daily living (ADL).

When giving gluteal injections, it is safest to use the upper outer quadrant. The choice of

site for injection must be based on good clinical judgment, using the best evidence

available and individualized client assessment. There is wide agreement in the literature

that the ventrogluteal site is preferable (Small, 2004). Review of the literature on relevant

injection procedure found that injury to the sciatic nerve was associated with use of the

dorsogluteal site for injection, because the sciatic nerve commonly courses this site. Sciatic

pain can affect only one side of the lower limb; the pain may be dull, sharp, or

accompanied by intermittent shocks of shooting pain beginning in buttock, travelling

downward into the back or side of the thigh and / or leg. Sciatic pain then extends below

the knees and may be felt in the feet. Sometimes symptoms may also include tingling

sensation, while sitting and trying to stand up may be painful and difficult. Coughing and

sneezing can intensify the pain (Yeomans, 2003). Some medical disorders that can cause

sciatica include: herniated discs, degenerative diseases of the lumbosacral spine, lumbar

spinal stenosis, spondylolisthesis, spinal tumors, infections and Intramuscular injection.

(Garfin, 2004) The management of sciatic pain can pose great difficulty to physicians and

other medical professionals, as it can arise immediately after an Intramuscular injection to

the buttock which traumatizes the sciatic nerve hence triggering radiating pain down its

route. Sciatica just like other forms of pains is a symptom of a problem at some point along

the sciatic nerve rather than an ailment in itself. There are different types of treatment

options available to Physiotherapists for the management of this kind of pain. Such options

include infra-red radiation, manipulative therapy, interferential therapy, and transcutaneous

electrical nerve stimulations, amongst others. Most times these options are used in

combination for maximal benefit (Sluka, 2000).

For years, clinicians have been using TENS in an attempt to manage pain. It has been

widely used in the treatment of various types of pain. It has also been shown that TENS is

highly effective in alleviating pain and reducing analgesic use following cesarean section,

orthopedic and thoracic operations as well as mixed surgical procedures. (AHCPR,

1992).TENS is defined by the America Physical Therapy Association as the application of

the electrical stimulation to the skin for pain relief (APTA, 1990). Usually, the frequency,

intensity, and pulse duration of the stimulation can be varied (Sluka, 2000). Conventional

TENS is the most common mode used clinically and applies high frequency (>50Hz) and

low intensity (below motor contraction, sensory only) stimulation parameters. Another

common mode of stimulation uses low frequency (<50Hz) and high intensity (motor

contraction) stimulation parameters (Robinson and Snyder – Mackler, 1995). Furthermore,

increasing stimulation intensity to produce a painful noxious response is usually given at

low frequency, and is called acupuncture – like TENS and is the least common (Robinson

and Snyder – Macker, 1995).

The economic cost and the psychological trauma associated with living with sciatica are

immense; hence this research work studies the impact of Transcutaneous Electrical Nerve

Stimulation (TENS) in the management of post injection sciatic pain. This will determine if

TENS modality can become an alternative means of management of sciatic pain caused by

intramuscular injections because it is non-invasive unlike other forms of procedures used in

sciatica pain management.

Transcutaneous Electrical Nerve Stimulation (TENS) is one of the therapeutic modalities

that when applied can activate large diameter mechanosensitive afferents which in effect

have potential to modulate pain transmission in the spinal cord. It produces sensory inputs

from low threshold afferent, which can ultimately inhibit pain transmission in the spinal

cord by closing the gate i.e. inhibiting Transmission cells (or T cells) excitability via the

substantia gelatinosa (or S G cells) (Robinson and Snyder, 1995). An alternative approach

is to stimulate the Aβ fibers which respond preferentially to a mechanical mode

stimulation, which will activate the opioid mechanisms, and provide pain relief by causing

the release of an endogenous opiate (encephalin) in the spinal cord (Walsh, 1997). Both the

patients and the physiotherapist can therefore have control over pain modulation and can

adjust the levels of this at anytime (Wood, 1996). Pain is a subjective sensation and

therefore difficult to measure. It is, however, important to quantify it for several reasons;

one of the most compelling reasons is that assigning a measurement of pain gives patients

some sense of control over their condition and has positive effects on their coping abilities.

Pain measurements also provide a means of assessing the efficacy of response to treatment

and prognosis. The Visual Analogue Scale (VAS) is a well-studied method for measuring

both acute and chronic pain, and its usefulness has been validated by several investigators

(Katz et al, 1999; Scot et al 1999; Carlson et al, 1983) However, the VAS is comparatively

time- consuming and requires ability to understand the abstract concept of the VAS line

and then relate it to distance from a zero mark. It also requires the use of a paper and pen.

As line length in VAS is the response continuum; many patients find it difficult to judge

distance accurately. Therefore the VAS has some practical limitations in a clinic setting

1.2 Statement of Problem.

Individuals who have sciatica pain are often ‗crippled‘ by it, and are driven to seek relief

from conventional medical treatment, alternative therapies, and miracle cures.

Consequently, sciatic pain has been viewed as a mysterious or spiritual problem- that is

more than a medical problem- by some not well informed victims (patients), because of its

seeming defiance to conventional pain relieving medications. Due to low level of

awareness by both medical and non medical persons about the role of physiotherapy in the

management of post injection sciatic pain and because of poor understanding of the

pathology of such pain, most patients seem to have lost track of how it came about and go

on to full embrace of alternative orthodox and non orthodox medication, but with minimal

success. One of the long term effects being that many of such patient with sciatica that

were later referred for physiotherapy are in chronic stages of the problem. This study

therefore examines the possibility of the use of TENS to bridge this gap. There were no

previous empirical studies on the effect of TENS in managing post injection sciatic pain.

This lack of precedence in this research had created problem of readymade standard

protocol for a research of this nature. However; the empirical studies on the effect of TENS

in managing pain generally would be strongly relied upon.

1.3 Purpose of Study.

1.3.1 General Objective:

This study was carried out to determine if TENS can reduce post injection sciatic pain

since it is known to have beneficial effect in the management of various other types of pain

such as cesarean section, orthopedic and thoracic operations as well as mixed surgical

procedures (AHCPR 1992). Moreover, TENS has also been found to be beneficial also to

those who suffer from acute musculoskeletal pain (Long, 1991).

1.3.2 Specific Objectives:

The study is aimed at determining

1. The effect of treatment duration on participants‘ recovery from post injection sciatic

pain after TENS application

2. The influence of sex on participants‘ recovery from post injection sciatic pain after

treatment by TENS

1.4 Research Question.

Will the use of TENS reduce post injection sciatic pain?

1.5 Hypotheses.

It is hypothesized that:

1. There will be no significant difference comparing the pain intensity scores of

experimental and control participants at the second, fourth, sixth, eight, and tenth

week

2. There will be no significant difference between the baseline pain intensity scores

of experimental and each of the second, fourth, sixth, eight, and tenth week.

3. There will be no significant difference comparing the baseline pain intensity

scores of control participants and each of the second, fourth, sixth, eight, and tenth

week.

4. There will be no significant difference comparing the baseline pain intensity of

experimental participants and each of the second, fourth, sixth, eight, and tenth

week.

5. There will be no significant difference comparing the baseline pain intensity of

control participants and each of the second, fourth, sixth, eight, and tenth week.

6. There will be no significant difference comparing the pain intensity scores of

both experimental and control participants at the second, fourth, sixth, eight, and

tenth week by gender.

1.6 Clinical Significance of Study.

The outcome of this study is capable of changing the approach to the management of post

injection sciatic pain and offer new hope to people who are continuously being terrified by

the pain scourge from intramuscular administration of injections. Pain sufferers (acute or

chronic) are known to spend heavily on orthodox and non orthodox pain relief medications.

Some patients are known to have resorted to visiting spiritual centers in an attempt to

obtain solutions to the pain of sciatica. In the health institution where patients for this study

were recruited, according to the information from the medical records of Landmark

Physiotherapy Clinic, Nnewi in 2006 about 5% of the total patients referred for

physiotherapy suffered radiating pain resulting from intramuscular injections. This fact no

doubt buttresses the need to find a more efficacious alternative treatment intervention

method for sufferers of sciatic pain as this could be the only way the myth surrounding it

could be resolved. This research work also aimed at contributing to the whole body of

knowledge especially as it concerns the management of post injection sciatic pain.

1.7 Delimitation of the study.

The study was delimited to patients that were below 11years and above 70 years. The study

was restricted to only patients with post injection sciatic pain who were referred

for physiotherapy management.

CHAPTER TW0

2.0 LITERATURE REVIEW

2.1 Sciatic Nerve Anatomy:

The sciatic nerve is the largest and longest single nerve in the human body, about as big

around as a thumb at its largest point (about 2cm) in breadth, and is the continuation of the

flattened band of the sacral plexus. The nerve originates in the lower spine as nerve roots

exit the spinal cord (through the bones in the spine), and extend all the way down the back

of leg to the toes (Garfin, 2005).

The sciatic nerve is actually a combination of nerves. It is formed on the right and left hand

of the lower spine by the combination of the fourth and fifty lumbar nerve and the first

three nerves in the sacral spine. Each nerve exits the spine between two vertebrae and is

named for the segment above it.

1.the nerve that exits between lumbar segment 4 and lumbar 5 (L4 and L5) is called the

L4 nerve root,

2.nerve that exits between the L5 and sacral segment 1 is called the L5. and,

3.the nerves that emerge from the sacral foramen are called the S1, S2 and S3 nerves (

Yeomans, 2003).

The five nerves group together on the front surface of the piriformis muscle (in the

buttocks) and become one large nerve –the sciatic nerve. The nerve travels down the back

of each leg, branching out to innervate specific region of the leg and foot (figure1).

In the lower thigh, above the back of the knee, the sciatic nerve divides into two nerves, the

tibial and peroneal nerves, which innervate different parts of the lower leg. This division

may take place at any point between the sacral plexus and the lower third of the thigh.

When it occurs at the plexus, the common peroneal nerve pierces the pirifomis (Yeomans,

2003).

1. The peroneal nerve travels laterally along the outer aspect of the knee to the upper foot.

2. The tibial nerves continue to travel downwards towards the feet and Innervate the heel

and sole of the foot (Yeomans, 2003).

The sciatic nerve makes motor and sensory supplies as well as the reflexes of the leg. It

connects the spinal cord with the outside of the thigh, the hamstring muscles in the back of

the thigh, and muscles in the lower leg and feet. As such, when the sciatic nerve is impaired

it can lead to muscle weakness in the leg and/or, numbness or tingling sensations

(Yeomans, 2003).

2.2 Sciatica and Sciatic Nerve:

Sciatica commonly refers to pain that radiates along the sciatic nerve and typically felt in

the buttocks, down the back of the leg and possibly to the foot. Sciatica is one of most

common forms of pain caused by compression of the spinal nerve, and the leg pain often

feels much worse than the back pain.Sciatica is actually a symptom and not a diagnosis.

The term literally means that a patient has pain down the leg from compression on the

sciatic nerve. The diagnosis is what is causing the compression such as a disc herniation

(Yeoman, 2003).The sciatic nerve is the largest single nerve in the human body. It runs

from each side of the lower spine through deep in the buttock and back of the thigh, and all

the way down to the foot, connecting the spinal cord with the leg and foot muscles.

Sciatica can result when the nerve roots in the lower spine are irritated or compressed.

Most often, sciatic pain is caused when the L5 or S1 nerve root in the lower spine is

irritated by a herniated disc. When this happens, pain radiates into the buttocks and back of

the thigh and calf, and tingling, and or burning or prickling sensation are also common

symptoms. Degenerative disc disease may also irritate the nerve root and cause sciatica,

FIGURE: 2 The Route of Sc iatic Nerve

Figure 1: It Shows the Route, the Branches and Motor Supplies of Sciatic Nerve.

(Adapted from Teomans, 2003

while conditions that mimic sciatica include piriformis syndrome and sacroiliac joint

dysfunction. Sciatica may also be felt if the nerve is actually mechanically compressed,

such as from spondylolisthesis, spinal stenosis, or arthritis in the spine (Yeoman, 2003).

Most cases of sciatica are caused by a simple irritation to the nerve and will get better with

time via conservative care. However, some sciatica symptoms may indicate a potentially

serious injury to the nerve.

1. If weakness or numbness is present, the nerve may be damaged and it is important to

seek attention from a health care professional.

2 If the nerve is compressed and the pain and symptoms are severe, surgery may

be warranted.

3. If there is bowel or bladder incontinence (inability to control the bowel or bladder)

and/ or progressive weakness or loss of sensation in the legs, the condition may be

serious and immediate medical attention should be sort.( Yeomans, 2003)

The nerve roots that exit the spine to form the sciatic nerve are extremely sensitive, and the

inner portion of the disc- the nucleus pulposis- that may herniate or extrude contains

proteins that are inflammatory and can easily irritate the nerve. Therefore, if some of the

inner portion of the disc (the nucleus pulposus) comes too close to the nerve, the nerve may

be irritated and become inflamed, causing sciatic pain – or sciatica.

The sciatic symptom one feels (sciatic nerve pain, numbness, tingling, and weakness) tend

to be different depending on where the pressure on the nerve occurs. The patient‘s pain and

sciatic symptoms can usually be traced to where the injured/irritated nerve originated in the

lower back.

2.3 Six leading causes of sciatica

Several different lumbar spine (low back) diso rders can cause

sciatica.Sciatica is often described as mild to intense pain in the left or

right leg. Sciatica is caused by compression of one or more of the five

sets of nerve in the low back. Sometimes it is called radiculopathy.

Radiculopathy is a medical term used to describe pain, numbness,

tingling, and weakness, in the arms or legs caused by nerve root

problem. If the nerve problem is in the neck, it is called ce rvical

radiculopathy. However, sometimes sciatica affects the low back; it is

called a lumbar radiculopathy.

The six most common causes of nerve compression are: (1) a bulging or

herniated disc (2) lumbar spinal s tenosis (3) Spondylolisthesis (4)

Pirifomis Syndrome (5) Spinal tumor (6) Trauma (intramuscular

Injection)

1. Lumbar bulging or herniated disc .

A bulging disc is also known as a contained disc d isorder. This means the

gel-like centre (nucleus pulposis) remains ‗contained‘ within the th in like

outer wall (annulus fibrosus) of the disc. A herniated disc occurs when

the nucleus breaks through the annulus. It is a ‗non -contained‘ disorder

when a disc bulges or herniated disc material can press against an

adjacent nerve root and can press against adjacent nerve tissue and cause

sciatica. The consequences of a herniated disc are worse. Not only does

the herniated nucleus cause direct compression of the nerve root against

the interior of the bony spinal canal, but the disc material itself also

contains an acidic chemical irritant (hyaluronic acid) that causes nerve

inflammation. In both cases, nerve compression and irri tation cause

inflammation and pain, often leading to extremity numbness, t ingling and

muscle weakness.

2. Lumbar spinal stenosis

Spinal stenosis is a nerve compression disorder most often affecting

mature people. Leg pain similar to sciatica may occur as a result of

lumbar spinal stenosis. The pain is usually posit ional often brought on

by activities such as standing or walking and relieved by si tting down.

Spinal nerve roots branch out from the spinal cord through passages

comprised of bone and ligaments. Between each set of vertebral bodies

located on the left and right sides, is a foramen. Nerve roots pass these

openings and extend outwards beyond the spinal column to innervate

other parts of the body. When these passage ways become narrow or

clogged causing nerve compression, the term foramina stenosis is used.

3. Spondylolisthesis

Spondylolisthsis is a disorder that most often affects the lumbar spine. It

is characterized by one vertebra slipping forward over an adjacent

vertebra. When a vertebra slips and is displaced; spinal nerve

compression occurs and often causes sciatic leg pain. Spondylolisthsis is

categorized as developmental (formed at birth, developed during child

hood or acquired from spinal degeneration, trauma or physical stress (i .e.

weight lifting).

4. Piriformis syndrome

Piriformis syndrome is named for the piriformis muscles and the pain

caused when the muscles irritate the sciatic nerve. The piriformis muscle

is located in the lower part of the spine connects to the thigh bone, and

assists in hip rotation. The sciatic nerve runs beneath the piriformis

muscles. Piriformis syndrome develops when muscle spasm develops in

the pirirformis muscles thereby compressing the sciatic nerve. It may be

difficult to diagnose and treat due to lack of adequate diagnostic

modalities l ike Magnetic Resonance Imaging .

5. Spinal tumors

Spinal tumors are abnormal growths that are either benign or cancerous

(malignant). Fortunately, spinal tumors are rare; in the lumbar region,

However; there is a risk for sciatica to develop as a result of

compression (Subach, 2006).

6. Trauma

Sciatica can result from direct nerve compression caused by external

forces to the lumbar or sacral spinal nerve roots. Examples include motor

vehicle accidents, falling down, football and other sports. The impacts

may injure nerves and occasionally fragments of bro ken bones may

compress the nerves. Also an intramuscular injection that touches or

pierces the sciatic nerves constitutes a trauma that does equally cause

sciatica. There could also be abscess formation which causes irritation of

the sciatic nerve following wrong administration of an intramuscular

injection.

When giving gluteal injections, it is safest to use the upper outer quadrant. The choice

of site for injection must be based on good clinical judgment, using the best evidence

available and individualized client assessment. There is wide agreement in the literature

that the ventrogluteal site is preferable (Small, 2004). Review of the literature on

relevant injection procedure found that injury to the sciatic nerve is associated with use

of the dorsogluteal site for injection, because the sciatic nerve commonly courses this

site. Ndiaye, (2004) performed sciatic nerve gluteal dissection on 10 fresh adult African

cadavers, on both sides. The nerve pathway was 19 times out of 20 in the subpiriformis

canal. In all cases the pathway was identical, with an oblique and vertical portion

running down through the ischio-trochanteric channel. The cutaneous projection of the

sciatic nerve was distant from the upper lateral quadrant of the buttock. The site of

injection is the crucial factor in determining the degree of nerve fiber injury. The degree

of injury varies significantly, depending upon the specific agent injected. The most

severe injuries have been associated with widespread axonal and myelin degeneration

(Gentili et al, 1980a). Pathological alterations in the nerve were evident as early as 30

minutes following injection injury (Gentili et al, 1980b).

Although post injection injury can occur in both adults and children, children appear to

be at higher risk (Krasnikova, 1986; Fatunde et al, 2001) did a retrospective study of all

children with a diagnosis of sciatic nerve injury during a 12-year period. They examined

27 children, 5 months-12 years of age, with a diagnosis of post injection sciatic nerve

injury. The drugs administered to 17 patients included chloroquine, novalgin,

paraldehyde, procaine penicillin, and sulfadoxine-pyrimethamine. However, the most

neurotoxic agents tested in a previous study appear to be penicillin G, diazepam, and

chlorpromazine (Yaffe et al, 1986). The postulated mechanisms of injury include direct

needle trauma, secondary constriction by scar, and direct nerve fiber damage, due to

both axon and Schwann cell, with a breakdown in the blood-nerve barrier by neurotoxic

chemicals in the injected agent (Gentili et al., 1980b; Villarejo et al, 1993) Neurological

sequelae can range from minor transient sensory disturbance to severe sensory

disturbance and paralysis, with poor recovery Villarejo et al, 1993). In one study, seven

patients (26%) presenting with foot drop had had recent IM injections in the buttock. An

additional 20 patients (74%) presented much later (Fatunde et al 2001). In fact, gluteal

IM injection that led to sciatic nerve injury most often presented as paralytic drop foot

(Mayer et al, 2001; Sobel et al, 1997).

Children who present with drop foot may later develop gluteal fibrosis (diagnosed 5.1

years after the injections). In contrast, sciatic nerve palsy, presenting as equinovarus or

equinus deformity, was diagnosed on average 3.8 months after the intragluteal

injections (Napiontek et al, 1993). Cavovarus and calcaneocavus foot deformities have

also been reported (Bigos et al, 1984). Medical treatments including administration of

vitamins and alphachymotrypsine have been tried with varying results, depending on the

extent of the lesion. Early (within 2 months) physiotherapy may provide a better chance

of recovery (Bourrel et al, 1982). Our patient presented 12 months after nerve injury

and, thus, his chances of recovery were small.

The recommended treatment ranges from a conservative approach to immediate

operative exposure and irrigation and has included early neurolysis or delayed

exploration with neurolysis or resection and anastomosis (Villarejo et al, 1993). Of 190

patients with gluteal sciatic nerve injuries in one retrospective study, the injuries were

caused by injection in 164 patients (86.32%). Fifteen were treated by conservative

means, and the other 175 had surgical intervention. Neurolysis was performed in 160

cases, epineural neurorrhaphy in 12 cases, nerve grafting in 2 cases, and nerve

exploration but no repair in 1 case. Late-stage functional reconstruction of the foot and

ankle was performed in 23 cases. Follow-up of 151 patients for an average 8.5 years

revealed excellent to good nerve recovery (i.e., 57% and 78% in the early and late stage,

respectively). It is believed that neurolysis should be performed as soon as possible in

cases of injection injury (Huang et al 2000).

Epineural neurorrhaphy should be performed in cases of nerve rupture. Functional

reconstruction of the foot and ankle should be carried out in the late stage for the

improvement of the limb function, if a surgical team is available for this purpose

(Huang et al, 2000). If performed within 24 hours after injury, neurolysis may prevent

the occurrence of paralysis (Mayer et al, 2001; Yaffe et al., 1986). The patient who

presented late in this study was offered physiotherapy rather than surgical treatment

because of his late presentation. To date, his improvement has been minimal. The

implications for nurses include the need to learn and practice safe injection technique.

Nurses must also assess for complications (both immediate and long term), and educate

patients.

2.4 Different Types of Sciatic Pain:

1. Sciatica from L4 Nerve Root (Usually the L3-L4 Level)

The patient may have reduced knee – jerk reflex. Symptoms of sciatica

stemming from this level of the lower back may include, pain and/ or numbness

to the medial lower leg and foot; weakness may include the

inability to do heel walk.

2. Sciatica from L5 Nerve Root (the L4-L5 Level)

The patient may have weakness in extension of the big toe and potentially

in the ankle (called foot drop). Symptoms of sciatica originating at this

level of the lower back may include: pain and/ or numbness to the top of

foot, particularly in the web between the great toe (big toe) and the

second toe.

3. Sciatica From S1 Nerve Roots (the L5– S1 Level)

The patient may have reduced ankle – jerk reflex. Symptoms of sciatica originating

at this level of the spine may include: pain/numbness to the lateral or outer foot;

weakness that results in difficulty in raising heel off the ground or walking on

tiptoe.

4. Pressure on the Sacral Nerve Roots from Sacroiliac Joint Dysfunction

Symptoms may include: a sciatica-like pain or numbness that is often described a

deep ache, inside the leg more so than a linear, well – defined geographic area

pain/numbness found in true sciatica.

5. Pressure on the Sacral Nerve Roots from the Piriformis Muscle

This pressure on the sciatic nerve can tighten and irritate the sciatic nerve

(piriformis syndrome) (figure 2). Symptoms of piriformis syndrome may include: a

sciatic like pain and / or numbness in the leg. Usually it is more intense above the knee,

and starts below the piriformis than the low back. Piriformis can mimic the signs and

symptoms of sciatica from a disc herniation and is of differential diagnosis of possible

causes of sciatica (Yeoman, 2003).

Figure 2: It Shows the Relationship Between the Piriformis Syndrome and Sciatic Nerve.

(Adapted from Yeomans, 2003)

2.5 Proper Use of the Sciatica Terminology

To clarify terminology, sciatica is often used to indicate any form of pain that radiate

into the leg.

1. If the sciatic nerve is pinched and the pain in the leg is from the nerve (radicular

pain) then this is a correct use of the term sciatica.

2. If the pain is referred to the leg from a joint (referred pain) then using term

sciatica is technically incorrect.

3 Referred pain from arthritis or other joint problems that may cause leg pain (feels

like sciatica) is actually more common than true sciatica (Yeomans, 2003).

In this study however, the term post injection sciatic pain and sciatica will be used

interchangeably because the clinical signs and symptoms mimics each other. The major

differences between the two arise from the cause(s) and the point of origination of the

pain. While the cause of sciatica is nerve root based and multi factorial that of post

injection sciatic pain is caused by direct needle trauma, secondary constriction by scar,

and direct nerve fiber damage, due to both axon and Schwann cell, with a breakdown in

the blood-nerve barrier by neurotoxic chemicals in the injected agent (Gentili et al.,

1980b; Villarejo et al, 1993). In terms of pain origin, though the irritation and nerve

impingement occur at the nerve roots, the associated sciatica could start manifesting

from any part of sciatic nerve other than the low back. In contrast to that of sciatica, the

pain from post gluteal injection never ever starts from the nerve roots but at or below

the injection site.

2.6 Transcutaneous Electrical Nerve Stimulation (TENS).

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive technique in

which a low-voltage electrical current is delivered through wires from a small power

unit to electrodes located on the skin. Electrodes are temporarily attached with paste in

various patterns, depending on the specific condition and treatment goals. TENS is

often used to treat pain, as an alternative or addition to pain medications. Therapy

sessions may last from minutes to hours. TENS devices can be set in a wide range of

frequencies and intensities, depending on patient preferences, desired sensations, and

treatment goals. "Conventional TENS" involves the delivery of high or low frequency

electrical current to affected areas. In "acupuncture-like TENS," lower frequencies are

used at specific "acupuncture points" or trigger points. TENS may also be applied to

locations on the ear ("auricular points"). Epidural stimulation and percutaneous

electrical nerve stimulation (PENS), which are not included in this review, are

invasive procedures that require penetration of the skin, implantation, or minor

surgery. (NSRC, 2007)

The practice of using electricity for pain control can be traced to 2500 BC and the

Egyptian Fifth Dynasty, in which stone carvings depict an electric fish being used to

treat pain. During the Socratic era, electrogenic torpedo fish (/Scribonius longus/)

were used to treat arthritis and headache. In the middle Ages, electrostatic generators

were used, and the discovery of the electric battery in the 19th century led to further

experimentation. The use of electrical stimuli for pain relief was popularized in the

19th century and became widespread in the 1960s and 1970s using battery power

(NSRC, 2007)

2.7 TENS Theory

The use of Transcutaneous Electrical Nerve Stimulation (TENS) in the management

of pain began as a pre surgical screening for chronic pain patients to determine

candidates for implantation of spinal column stimulators (Wall and Sweet, 1967;

Burton, 1975; Buton and Maurer, 1978; Woolf and Thompson, 1994).However,

patients reported substantial pain relief following TENS treatment and thus did not

even require implantation of the dorsal column stimulators. Since that time, numerous

studies have attempted to determine the effectiveness of TENS treatment for

individuals with a variety of pain conditions (Nolan, 1988; Robinson, 1996; Feine and

lund, 1997).

However, much of the published research shows conflicting results about the actual

efficacy and duration of the effect of TENS application. Several factors contribute to

these conflicting reports, including:

(1) unspecified stimulation parameters,

(2) stimulation variables not controlled during the research process,

(3) different outcome measures,

(4) different electrodes placements,

(5) lack of placebo control,

(vi) patients presenting at different stages in disease process, and

(vii) failure to monitor or document patient compliance: (Mannheimer, et al 1978:

Mannheimer, et al 1978: Kumar and Redford, 1982: Levy, et al, 1987: Reitman and

Esses, 1995: Robinsion: 1996).

The extensive use of TENS over the past 25 years has established this inexpensive,

non-invasive technique as an accepted modality for pain relief. The works by Johnson

et al (1991) and Tulger et al (1991) have made significant contributions to identifying

optimum parameters for electrical stimulation. The exact method of how pain is

inhibited relies on a full understanding of the pathology of the injury and the

subsequent changes which may take place in the nerve pathway and the central

nervous system. Modulation of normal physiological pain gate pathways can lead to

pain relief. TENS works to alter or block the noxious agents that cause pain hence

relieving pain.

2.8 Empirical Review of Literature

TENS has been hypothesized to improve pain in multiple ways. Theories included

effects on sensory nerves (Hiroka, 2002), interference with sensory-discriminative

pathways (Bushnell et al,1991;Marchand et al,1993;Sanderson et al,1995), stimulation

of release of natural chemicals that affect the way pain is perceived and transmitted

(for example, encephalins and endorphins) (Abeyenker et al,1994; Almay et al

1985;Sjolund et al,1977), or through increased blood flow in treated areas such as the

skin or heart(Kjartansson,1988; Lundeberg et al,1998). Recent data suggested pain

relief from low and high frequency TENS is mediated by the release of mu or delta-

opioids, respectively, in the central nervous system (Chandran, 2003; Sluka et al,2002)

and reductions in substance P (Rokugo et al, 2002). However, none of these

mechanisms had been clearly established in scientific research, and the basis of

activity of TENS remains controversial. Theories used traditionally to explain

acupuncture had also been offered, citing effects on flow of vital energy. It is also

sometimes suggested that TENS may affect the cardiovascular system, increasing

heart rate and reducing blood pressure (Campbell et al, 2002).

Many studies of TENS compared the technique to "placebo" techniques in which a

TENS-like control box and electrodes may be used without delivering electric current

to the patient. However, patients can often tell if no current is delivered, which lessens

the quality of these studies. Much of the researches on TENS were not well designed

or reported. Several small randomized controlled trials in adults (Hansson et

al,1983;Meechan,et al, 1998 ; Soo-Ampon et al,1997) and children (Harvey et al,

1995) reported pain reduction or reduced need for pain medications during dental

procedures with the use of various TENS techniques. These studies provided

promising preliminary evidence but did not include clear descriptions of research

design or results. Therefore, better research is necessary before a strong

recommendation can be made.

Multiple randomized controlled trials have examined the effects of TENS in patients

with osteoarthritis of the knee (Cheing et al, 1992; Fargas-Babjak et al, 1992). Overall,

the results reported improvements in knee stiffness and pain, although it was not clear

that walking distance or swelling were improved. The available studies had been small

without clear descriptions of design or results. Therefore, better research is necessary

before a strong recommendation can be made.

Auricular TENS is sometimes used in Europe to reduce the need for anesthesia during

surgical procedures. There was not enough reliable evidence to draw a firm conclusion

in this area (Grief et al,2002).Preliminary research suggested that TENS might benefit

some symptoms of Alzheimer's disease, including mood, memory, and cycles of daily

rest and activity (Scherder et al, 1995; VanSomeren et al, 19983). Additional human

study is necessary before a firm conclusion can be drawn. Several small, brief studies

reported benefits of TENS on angina pectoris pain (Mannheimer et al, 1986;

Mannheimer et al, 1989). However, most studies were conducted during the late 1980s

and early 1990s, and were not well designed or reported. New drugs for heart disease

had been developed since these studies were conducted, and people with heart disease

or chest pain were advised to seek immediate medical attention from a licensed

physician.

The effects of TENS or acupuncture-like TENS on low back pain remained

controversial, and multiple controlled trials had been published in this area (Deyo et

al, 1990; Jardem et al, 1997).Studies had not been consistent in the type of TENS

techniques used (location, intensity, frequency, duration) or in definitions of back

pain, and most trials had not been well designed or reported. Published meta-analyses

had grouped some of these studies together to try to determine whether this technique

was effective, but had also yielded inconsistent results, with some authors reporting

overall benefits, and others finding no clear advantage over placebo (Gadsby et al,

1997; Milne et al 2001). Better-designed research is needed before a firm conclusion

can be reached. The effect of TENS on chronic pain of various causes and locations

remained controversial, and multiple controlled trials had been published in this area

(Carroll et al, 2001; Jeanset et al, 1979; Thorsteinsson,et al, 1977). Although

numerous studies reported benefits, studies had overall been small, poorly designed,

and without clear descriptions of results. Better-designed research is needed before a

firm conclusion can be reached. TENS had been examined for the treatment of

dysmenorrheal in several small studies (Lundeburg et al, 1985; Mannheirmer, 1985).

Research in this area suggested that the use of TENS may reduce short-term

discomfort and need for pain medications. However, the available trials did not clearly

describe study designs or results. Most outcomes are not measured using validated

scales. Overall, blinding, randomization, dropouts, and statistical analysis were not

well described and sample sizes were small. Therefore, the research in this area

remained indeterminate. Preliminary controlled trials suggest that TENS may have

some benefits in patients with migraine or chronic headache (Hydenreich et al, 1989;

Solomon et al, 1985). Additional well-designed research is necessary before a firm

conclusion can be reached in this area. The effect of TENS on labor pain remained

controversial, and multiple controlled trials had been published in this area (Bundsen

et al, 1982, Carrol et al, 1997). Although some research reported small benefits,

including reduced need for pain medications, studies had overall been small, poorly

designed, and without clear descriptions of results. Better-designed research is needed

before a firm conclusion can be reached. It is not clear if passage of electricity using

TENS has harmful effects on the fetus.

Several case reports and a small number of controlled trials (Kumar et al, 1997;

Kumar et al; 19981) reported improvements in pain symptoms in people with

peripheral neuropathy or nerve damage. However, these studies had not been well

designed or reported and additional research is needed before a firm conclusion can be

drawn about effectiveness. There was not enough reliable evidence to draw a firm

conclusion in this area (Finsen et al, 1988; Katz, et al 1991). Promising preliminary

research requires confirmation with better quality studies. There were multiple

controlled studies of TENS for pain following various types of surgery, including

abdominal surgery (Akyx et al, 1993; Menzel et al, 1977), heart surgery (Bayinder et

al, 1991), lung surgery (Rooney et al, 1983), gynecologic surgery (Smith et al, 1991),

and orthopedic surgery (Alm et al, 1979; stabile et al 1978) .Research was

inconsistent, with a variety of TENS techniques, patient types, and study designs used.

Overall, the quality of available research was poor. Although some studies did report

improvements in pain and reduced need for pain medications, a well-designed review

in 1996 concluded that there was no clear evidence of benefit (Caroll et al, 1996).

Better quality research is necessary in this area before a strong conclusion can be

reached.

Studies of TENS in post-stroke rehabilitation reported inconsistent findings, and

benefits had not consistently been demonstrated (Johanson et al, 2001; Sonde et al,

2000; Sonde et al, 1998). Additional research is necessary before a clear conclusion

can be reached. Preliminary studies of TENS in rheumatoid arthritis report

improvements in joint function and pain (Kumar et al, 1982; Manheirmer et al, 1978).

However, most research is not well designed or reported and better studies are

necessary before a clear conclusion can be reached.

There had been limited non-controlled trials of TENS in spinal cord injury. Well-

designed controlled trials are required to recommend for or against the use of TENS

for this indication. There was insufficient reliable evidence to recommend for or

against the use of TENS in temporomandibular joint pain (Davis et al 1975; Hachen et

al, 1978; Richardson et al, 1980).There was not enough reliable evidence to draw a

firm conclusion in the area of using TENS to manage urinary incontinence/ detrusor

instability in patients (Okada et al, 2001; Soomro et al; 2001). It had been established

that high-frequency TENS treatment reduced nausea, dizziness, and prurities

associated with morphine intake compared with morphine alone or with sham TENS

in post operative patients (Wang et al; 1997), furthermore, increasing pain relief by

TENS in combination with other therapies will allow the patient‘s ability to increase

activity level and thus reduce hospital stays and speed the return to work. Treatment

with TENS increased joint function in patients with arthritis ( Abelson et al, 1983;

Kumar et al,1982; Mannheimer et al, 1979; Mannheimer et al,1978; Zizic et al, 1995),

decreases the stay in the recovery room In patients following thoracic surgery (

Warfied et al, 1995), increases pulmonary function ( measured as vital capacity,

functional residual capacity, and arterial po2 ( Ali et al, 1981), and improves the

physical and mental component summary on the quality of life survey short form ( SF-

36) in patients with chronic pain (Ghoname et al, 1999).thus several studies supported

a decrease in opioid. A decrease in side- effects of opioids and an increase in variety

functional tests in patients using TENS. Improving physical function allows the

patient to tolerate other therapies and activities resulting in an improved quality of life

There was no evidence to show that TENS was useful in the following medical

conditions: Achalasia, antiviral, atopic eczema, bursitis, carpal tunnel syndrome

(Bodofsky et al,2002), cerebral blood flow enhancement, cognitive function (Van Dijk

et al,2002), dementia, depression, dystonia, esophageal spasm, fibromyalgia, fracture

pain (Oncelet al,2002), Guillain-Barre syndrome, hemophilia, herpes, hip pain,

interstitial cystitis, itch (Tinegate et al, 2002), joint pain, labor induction, local

anesthesia, menstrual cramps, MPD syndrome, multiple sclerosis, muscle cramps

(Mills et al,1982), muscle strains/pain (Dlin et al,1980), muscle spasticity,

musculoskeletal trauma, nerve damage, osteoarthritis, pancreatitis, calcarea (Kaada et

al,1984), Raynaud's phenomenon, repetitive strain injuries, sacral pain, schizophrenia,

shingles, shoulder subluxation, sickle cell anemia pain, sphincter of Oddi disorders,

sports injuries, thrombophlebitis, tinnitus, tremor (Munhoz et al,), utero-placental

perfusion enhancement, whiplash.

2.9 Pain and Gender

Subtle genetic and psychological variations are increasingly recognized to contribute to

pain and analgesic efficacy and safety. The influence of sex on this relationship remains

poorly understood, particularly in humans. The issue is complicated by the overlay of

gender onto physical sex, and its associated stereotypes and expectations. Women

appear to use more pain-relieving medications than men; however, it remains unclear

whether these observations represent true differences in analgesic usage patterns, or

reporting bias. Differences in analgesic efficacy relating to body composition,

metabolism and hormonal profiles have been demonstrated. Psychological and social

elements of gender have also been associated with altered pain experiences and

analgesic use profiles, albeit with significant individual variations. Intra-group

differences may ultimately prove more important than sex differences. Further research

may unravel the various threads linking gender and sex effects on analgesia with the aim

of individualizing analgesia to optimize pain relief.

Pain and its relief are common problems in medicine. Single analgesics may lack

clinical efficacy but, in the laboratory, studies demonstrate sex differences and in

practice multiple therapeutic interventions are used without rigorous studies (Holdcraft

et al 2006) In the context of orthodox science and evidence-based medicine, the greatest

regard is given to symptoms and therapies that can be tested and validated. This requires

variables that lend themselves to reproducible, objective and quantitative measurements.

These demands are necessarily in direct conflict with the internationally accepted,

subjective definition of pain. The study of experimental pain in human subjects is

restricted by the specific ethical constraints on intentional infliction of such an

experience.

Furthermore, biological, psychological and social confounders interfere with attempts to

objectify and quantify pain. Individuals' experiences of pain, like any other emotional

experience, are hugely diverse and 10/11-point scales and surveys do as little justice to

the variations of pain as they do to those of anger, fear or love. (Robinson et al, 2004)

Rat and mouse models are the most common animal models in use, and attempt to

circumvent some of these issues by minimizing social influences. However, as rodents

cannot articulate 'pain' experiences, its presence, intensity and quality are inferred from

observation of physical and behavioral response to presumed noxious stimuli. Clearly,

such inferences have questionable accuracy. In addition, pharmacokinetics of

antinociceptive drugs in rodents can significantly differ from humans (e.g., the hepatic

metabolism of morphine).(Craft et al,2003)

International professional groups have championed the importance of identifying and

managing pain as a basic human right, in recognition of the physical and emotional

suffering it causes.(Brennan et al 2007).Furthermore, pain is often the limiting factor in

other activities, with financial and social implications. Pain may cause health problems;

for example, poorly controlled postoperative pain predisposes to morbidity as a result of

reduced lung function (Robinson et al 2004). Increasingly, evidence also suggests that

poor control of acute pain is a risk factor for the development of chronic pain, with its

attendant psychosocial issues (Morita et al 2008). For all these reasons, aggressive pain

management is a key healthcare aim, including consideration of pain assessment as the

fifth vital sign, medication and adjuvant therapies. (Morita et al, 2005). Both men and

women may experience suboptimal management of pain disorders, albeit at different

frequencies and for different reasons. A recent in-hospital survey recorded a 91%

incidence of pain, yet only 29% received analgesics, with women having a significantly

higher probability of receiving pain-relieving drugs (Visentin et al 2005)

A female preponderance is found in many conditions that can cause chronic pain in the

head and neck, limbs and non reproductive internal organs. The incidence of such pain

can change across a lifespan, often in response to sex hormone alterations (Cairns et al

2005) and some disorders co-occur with increased morbidity, for example irritable

bowel syndrome, interstitial cystitis, migraine and fibromyalgia (Berkley et al, 2005)

Despite this, beliefs that women have a higher pain threshold than men and are better

able to tolerate pain pervade both lay and medical communities. The origins of these

beliefs are unclear, although it appears that men and women conceptualize pain

differently, (Sela et al, 2002) which may influence their presentation, for example, with

acute coronary syndromes (Canto et al, 2007). Observation of the specific and powerful

phenomenon of pregnancy-induced analgesia (Tarvis et al, 1997) may inform popular

opinion. In addition, women have been observed to use significantly less opioid drugs

(i.e., opioid receptor agonists) than men to achieve equivalent analgesia after the

immediate postoperative period.( Chia et al, 2002) Repeated anecdotal reports of similar

observations could contribute to an unproven doctrine of superior female pain tolerance.

However, increasing evidence suggests that such beliefs may be partly, if not fully,

erroneous. In addition to a lower pain threshold, women may derive fewer benefits from

analgesic medication owing to higher baseline pain measures as well as pharmacological

differences and observer bias.(Roseland et al, 2004) By contrast, men may be less aware

of unwanted effects associated with analgesics as well as being differently susceptible to

them. Both sexes may also deny or minimize pain in attempts to avoid unwanted effects

of analgesics, and sex-specific effects (e.g., erectile dysfunction) have been recently

noted in patients receiving opioids and NSAIDs (Daniel et al, 2002).This may prevent

men from receiving appropriate analgesia. A multimodal therapeutic approach may

provide more benefit to women because they are self-motivated to affect this (Myers et

al, 2003) and, in the context of comorbidity, women anecdotally report that analgesia for

one disorder provides pain relief for another. Several recent excellent reviews explore

the genetic, hormonal and social basis for sex and gender differences in pain responses

and the animal basis for querying similar differences in analgesic responses (Dahan et

al, 2008).

However, because there was dearth of literature on the effect of TENS on post injection

sciatic pain the influence of gender on TENS application has not been documented

hence this study amongst other objectives made an attempt to also determine if there

was any sex influence in participants response after 10 weeks of TENS application.

2.10 Pain Gate Control Theory

This is a famous theory propounded by Wall and Melzack (1995) concerning the

mechanism by which pain is transmitted. This theory states that pain is a function of the

balance between the information traveling into the spinal cord through large nerve fibers

and information traveling into the spinal cord through small nerve fibers. If the relative

amount of activity is greater in large nerve fibers which carry non-nociceptive

information, there should be little or no pain. However, if there is more activity in small

nerve fibers which carry nociceptive information then there will be pain (Chudler,

2003). Presynaptic inhibition larger, myelinated Aβ fibres provide the pathway for

TENS. These fast-conducting fibres are highly sensitive to electrical stimulation and

quickly conduct the electrical impulse to the spinal cord. Small, slower conduction non-

myelinated C fibres carrying noxious (painful) stimuli are unable to pass on their

message. The mechanism by which nociceptive fibres (pain – carrying fibres) are

prevented from passing on their message to the spinal cord is described as presynaptic

inhibition (Wagman and Price, 1969; Handwerker et al, 1975; Woolfe and Wall, 1982;

Chung et al, 1984). The opening or closing of the gate to noxious or painful stimuli will

dictate an individual‘s awareness of noxious or painful stimulus. Stimulation of the

afferent fibres by TENS may provide one mechanism to keep the gate closed to painful

stimuli. This inhibitory process possibly modulates the sensory input entering the spinal

cord. The use of TENS may distort the function of the nervous system by jamming one

of its inputs (Woolfe, 1989). The closer TENS is to the damaged area, the greater the

noxious stimuli will be inhibited appropriately.

The circuits mediated by Aβ—fibres are segmentally arranged. So low-intensity

segmental inhibitory circuits are required. Other poly-segmental inhibition circuits,

which are mediated by A & C afferents, require higher-intensity stimuli (trigger-point

acupuncture). (Famptom, 1994; Bowsher, 1994; Alitnee, 1994) for activation.

Low-frequency TENS is usually given at intensities that produce motor contraction

(high Intensity) and high-frequency TENS is given at lower intensities that produce a

sensation without motor contraction (low intensity), it is still unknown if the effects of

TENS are a result of differences in frequency or intensity. Specifically, increasing

intensity, frequency, or pulse duration increases the amount of Inhibition of dorsal horn

neurons produced by TENS. The study by Sjolund, (1988), suggests that high-frequency

TENS is more effective than low frequency TENS, increasing intensity increases

inhibition, and the effects of TENS are short.

The development of Transcutaneous Electrical Nerve Stimulation is based directly on

Wall and Melzack (1965) innovative work on the spinal pain gate control theory (figure

3) and the pain modulation. Research examining pathological changes occurring in

nerves following injury led to the scientific justification for applying electrical impulses

to damaged nerves in order to modify their abnormal responses. These findings and the

gate theory form basis of much of our understanding of pain mechanism and clarify the

therapeutic value of electrical nerve stimulation.

2.11 TENS Parameters:

Before attempting to describe how TENS can be employed to achieve pain relief, the

main treatment variables which are available on modern machines will be outlined. The

location of these controls on a typical TENS machine is illustrated in the diagram

(figure 5).

The current intensity (A) (strength) will typically be in the range of 0 to 80 mA, though

some machines may provide outputs up to 100mA. Although this is a small current, it is

sufficient because the primary target for the therapy is the sensory nerves, and so long as

sufficient current is passed through the tissues to depolarize these nerves, the modality

can be effective. The machine will deliver ―pulses‖ of electrical energy, and the rate of

delivery of these pulses (the pulse rate (B) will normally be variable about 1 or 2 pulses

per second (pps) up to 200 or 250 (pps). To be clinically effective it is suggested that the

TENS machine should cover a rate from about 2 to 150Hz. In addition to the stimulation

rate, the duration (or width) of each pulse (C) may be varied from about 40 to 250 micro

seconds (us). (a micro seconds (us). (a micro second is a millionth of a second). Recent

evidence would suggest that this is possibly a less important control than the intensity or

the frequency.

In addition, most modern machines will offer a BURST mode (D) in which the pulses

will be allowed out in bursts or ‗trains‘, usually at a rate of 2-3 bursts per second.

Finally, a modulation mode (E) may be available which employs a method of making

the pulse output less regular and therefore minimizing the accommodation effects which

are often encountered with this type of stimulation.

The reason that such short duration pulses can be used to achieve these effects is that the

targets are the sensory nerves which tend to have relatively low thresholds (i.e. they are

quite easy to excite) and that they will respond to a rapid change of electrical state.

There is generally no need to apply a prolonged pulse in order to force the nerve to

depolarize, therefore stimulation for less than a millisecond is sufficient. Most machines

offer a dual channel output – i.e. two pairs of electrodes can be used to stimulate the

skin simultaneously (figure 5). In some circumstances this can be a distinct advantage,

though it is interesting that most patients and therapists tend to use just a single channel

application. The pulses delivered by TENS stimulators vary between manufacturers, but

tend to be asymmetrical biphasic modified square wave pulses.

Excitatory and Inhibitory Influences on T-cellFigure: 4aClayton 1994

Figure 3: It showed the interplay between the large diameter (excitatory) afferents and

small diameter (inhibitory) afferents on the Transmission Cell (T-Cell). (Clayton, 1994).

FIGURE: TENS parameters

.

Figure 4: This Show TENS Controls

The biphasic nature of the pulse means that there is usually no net DC component,

thus minimizing any skin reactions due to the build up of electrolytes under the

electrodes. (Chesterton, 2003

2.12 Mechanism of Action:

The type of stimulation delivered by the TENS unit aims to excite (stimulate) the

sensory nerves, and by so doing, activate specific natural pain relief mechanisms. For

convenience, if one considers that there are two primary pain relief mechanisms which

can be activated: the Pain Gate Mechanism and the Endogenous opioid system, the

variation in stimulation parameter used to activate these two systems will be briefly

considered.

Pain relief by means of the pain gate mechanism involves activation (excitation) of the

beta sensory fibers, and by so doing reduce the transmission of the noxious stimulus

from the ‗c‘ fibers, through the spinal cord and on to the higher centre. The Aβ fibers

responds better when stimulated at a relatively high rate (in the order of 90 – 30 Hz or

pps) but but it is difficult to find support for the concept that there is a single

frequency that works best for every patient, this range appears to cover the majority of

individuals. An alternative approach is to stimulate the Aβ fibers which respond

preferentially to a mode stimulation, which will activate the opioid mechanisms, and

provide pain relief by causing the release of an endogenous opiate (encephalin) in the

spinal cord. A third possibility is to stimulate both nerve types at the same time by

employing burst mode stimulation. In this instance, the higher frequency stimulation

output (typically at about 100 Hz) is interrupted (or burst) at the rate about 2 --3 bursts

per second. When the machine is ‗on‘, it will deliver pulses at the 100Hz rate, thereby

activating the Aβ and the pain gate mechanism, but

Fig

Figure 5: This Shows TENS With dual channel Electrodes Used in this Research

Work

by virtue of the rate of the burst, each burst will produce excitation in the A delta

fibers, therefore stimulating the opioid mechanisms.For some patients this is by far the

most effective approach to pain relief, though as a sensation, numerous patients find it

less acceptable than other forms of TENS. (Ellis, 1991)

2.13 TENS Modes:

1. Traditional TENS (Hi TENS, Normal TENS)

Usually uses stimulation at a relatively high frequency (90 – 130 Hz) and employs a

relatively narrow pulse width (start at 100µ ) though as mentioned above, there is less

support for manipulation of pulse width in the current research literature. The

stimulation is delivered at ‗normal intensity‘-definitely there but not uncomfortable.

30 minutes is probably the minimal effective time, but it can be delivered for as long

as needed. The main pain relief is achieved during the stimulation; with a limited

‗carry over‘ effect- i.e. pain relief after the stimulation machine has been switched

off.(Chesterton et al, 2003)

2. Acupuncture or Burst TENS (Lo TENS, Acu TENS)

Uses lower frequency stimulation (1-5Hz) with wider (longer) pulses (150-250µs).

The intensity employed will usually need to be greater than with the traditional TENS

– still not at the patient‘s threshold, but quite a definite, strong sensation. It takes some

time for the opioid levels to build up with this type of TENS and hence the onset of

pain relief may be slower than with the traditional mode. Once sufficient opioid has

been released however, it will keep on working after cessation of the stimulations.

Many patients find that stimulation at this low frequency at intervals throughout the

day is an effective strategy. The ‗carry over‘ effect may last for several hours.

3. Brief Intense TENS

This TENS mode that can be employed to achieve a rapid pain relief, but some

patients may find the strength of the stimulation too intense and will not tolerate it for

sufficient duration to make the treatment worthwhile. The pulse frequency applied is

high (in the 90 – 130Hz band) and the pulse width is also high (200, µs plus). The

current is delivered at, or close to the tolerance level for the patient – such that they

would not want the machine turned up any higher. In this way, the energy delivery to

the patients is relatively high when compared with the other approaches. It is

suggested that 15 – 30 minutes at this stimulation level is the most that would

normally be used.(Chesterton et al, 2003)

4. Burst Mode TENS:

As described above, the machine is set to deliver traditional TENS, but the Burst

mode is switched on, therefore interrupting the stimulation outflow at rate of 2 – 3

burst/second. The stimulation intensity will need to be relatively high, though not as

high as the brief intense TENS – more like the Lo TENS.( Chesterton et al, 2003)

2.14 Frequency Selection:

With all of the above mode guides, it is probably inappropriate to identify very

specific frequencies that need to be applied to achieve a particular effect. If there was

a single frequency that worked for everybody, it would be easier, but the research does

not support this concept. Patients need to identify the most effective frequency for

their pain and manipulation of the stimulation frequency dial or button is the best way

to achieve this. Patients who are told to leave the dials alone are less likely to achieve

optimal effects.(Kathleen et al, 2003)

2.15 Stimulation Intensity:

As identified above, it is not possible to describe treatment current strength in terms of

how many micro-amps. The most effective intensity management appears to be

related to what the patient feels during the stimulation, and this may vary from session

to session. As a general guide, it appears to be effective to go for a ‗definitely there

but not painful‘ level for the normal (high) TENS, and a strong but not painful level

for the acupuncture (lo) mode.(Chesterton et al,2003)

2.16 Electrodes Placement:

In order to get the maximal benefit from the modality, target the stimulus at the

appropriate spinal cord level (appropriate to the pain). Placing the electrodes on either

side of the lesion – or pain areas, is the most common mechanism employed to

achieve this (Ali et al, 1981). There are many alternatives that have been researched

and found to be effective – most of which are based on the appropriate nerve root

level.

1. Stimulation of appropriate nerve root(s)

2. Stimulation the peripheral nerve

3. Stimulation of motor point

4. Stimulation of trigger point(s) or acupuncture(s)

5. Stimulation the appropriate dermatome, myotome or scleratome (Sluka et al, 2003).

If the pain source is vague, diffuse or particularly extensive, one can employ both

channels simultaneously. A 2 channel application can also be effective for the

management of a local plus a referred pain combination – one channel used for each

component.

2.17 Precautions and Contraindications of TENS

TENS is generally reported as well tolerated. Skin irritation and redness are the most

common adverse reactions (Annal et al, 1992; Brill et al, 1992), occurring in up to

one-third of patients (Green et al, 1991; Johnson et al, 1978). Hives, welts, or contact

dermatitis/allergic skin reactions may occur with the use of electrodes and electrode

paste. Electrical burns may occur with excess use or improper technique (Fisher et al,

1978). Due to the risk of burns, TENS should be used cautiously in people with

decreased sensation, such as with neuropathy.

TENS should not be used in patients with implantable devices such as defibrillators,

pacemakers, intravenous infusion pumps, or hepatic artery infusion pumps (Pyatt et al,

2003). Electrical shocks or device malfunction may occur. There are isolated case

reports of lung atelectasis and edema, paresthesias, pain, and increased hair growth

with the use of TENS. Seizures have been reported, and TENS should be used

cautiously in people with seizure disorder (Rosted, 2001). Unpleasant sensations at

and away from the site of TENS, headache, muscle aches, nausea, agitation, and

dizziness have also been reported (Richardson et al, 2002). It was also sometimes

suggested that TENS may affect the cardiovascular system, increasing heart rate and

reducing blood pressure (Campbell et al, 2002).

TENS cannot be recommended during pregnancy due to insufficient evidence, and

due to a theoretical risk of harm to the fetus. Fetal heart rate may be elevated

(Bundsen et al, 1982). Although multiple trials of TENS for pain relief during

childbirth have been published, interference with fetal heart monitoring equipment

may occur (Hughes et al, 1988), and this technique should not be used unless under

the strict supervision of an experienced licensed healthcare practitioner. Safety of

TENS is not established in children.

CHAPTER THREE

3.0 METHODS AND PROCEDURE

3.1. Materials/Equipments of Study.

1. A dual channel TENS (EZ 105 Model) with variable pulse frequency of 2-

250Hz, variable pulse width of 50-250 micro seconds and variable pulse

intensity (amplitude) of 0-80mA produced by Avionix Medical Devices,

Texas, USA was used for both the test group and the control group.

2. Stethoscope-Littamn‘s model

3. Mercury Sphygmomanometer (Accusson model)

4. Cotton and pin for skin sensation test.

5. Measuring tape for muscle bulk measurement.

6. Toilet soap, NAFDAC approved sachet water, and hand towel for skin

cleansing.

7. Visual analogue scale by Price et al (1983). Used for pain assessment pre and

post treatment.

8. A Seca model weighing scale calibrated in kilogram.

9. A Seca model standiometer calibrated in centimeter and inches.

3.2 Research Design

This study was a randomized clinical trial involving seventy two participants-forty

experimental and thirty two control participants. The participants were blinded to the

treatment they received and randomly assigned to either Group A (Test Subject) or

Group B (Control Subject) using a table numbers.

3.3 Sampling Technique

The purposive sampling technique was applied since all the subjects/patients were

required to have met a certain selection criteria before being allowed to participate in

the study. The criteria were clearly spelt out to the prospective patients before ever the

selection to determine those who were qualified for participation.

3.4 Sample size

The sample size determination was based on the 17% prevalence of injection palsy

yearly as reported by Fatunde and Famulusi (2001) in Nigeria

Sample size (n) = Z2p (1-p)

d2

(Daniel, 1999)

p=prevalence=17%=0.17

Z=Z statistic for 95% level of confidence=1.96

d=precision=0.05

it is recommended by various authors (Lwanga and Lemeshow, 1991; Daniel, 1999;

Naing et al, 2006) that a precision of 5% is appropriate for prevalence rates between

10% and 90%.

n=1.962 x 0.17(1-0.17)

(0.05)2

n= 3.8416 x0.1411

0.0025

n=0.54197921

0.0025

n= 217

Calculated sample size=217

3.5 Inclusion Criteria

The category of subjects that qualified for this study after careful clinical

assessments were:

1. Those whose sciatic pain resulted from intramuscular injections only with the

pain radiating down the sciatic route.

2. Those patients with unilateral involvement of lower limb.

3. Those patients whose sciatic pain have existed for not more than one year and

have not suffered serious muscular wasting.

4. The subjects who presented with an accompanying foot drop.

5. Those subjects who agreed to stop all forms of analgesic medications within a

period of two weeks prior to study till the end of the experiment. This became

necessary in other to prevent the analgesic effect of the drugs from interfering

with effect of TENS.

6. Patients who had not been diagnosed as having osteoarthritis of the affected

lower limb.

7. Patients who had not been confirmed as having degenerative changes in the

lumbar region by a radiologist.

3.6 Clinical Evaluation of Patients

Those patients that met the criteria for participation and whose informed consents

were obtained were made to undergo some clinical assessment routines which

included, medical history, review of current medications, a physical and neurological

examination, examination of X-ray reports of the patients, range of motion test for all

the joints, sensory and motor deficit tests and patients‘ gait pattern observation.

3.7 Treatment Procedures

A. Group A (experimental Group)

1. Only TENS application was used on the 42 subjects that participated in this A

Group. Each patient was then made to lie on the available treatment plinth in a

position ( prone lying) that was most comfortable for the patient and very suitable

for TENS application.

2. The Electrodes Placement

The TENS adhesive electrodes available in this study were four in number in the

dual channel type of TENS. The four adhesive electrode pads were securely placed

along the route or course of the presenting sciatic pain (Figures 9, 10 and 11) as

maximum pain relief is obtained when the electrodes are placed on the painful area

(Ali et al, 1981). This electrode placement method was applied throughout the

period of study for both the GROUP A and GROUP B subjects.

The adhesive TENS electrodes were secured to the identified painful skin site that

have been cleansed of dirt and oily substances. The subjects were prepared via

explanation so that they would understand how the TENS machine works. They

were told that the sensation that TENS produced was not harmful to the skin.

3. TENS Mode

Acupuncture TENS which uses lower frequency stimulation (2-5Hz) and a wider

(longer) pulse width of (200-250us) with intensity greater than that of the

traditional TENS was chosen because of its ―carry over effect‖.

With all settings on zero the TENS machine was switched on and the output

increased until the patient perceives a fairly strong buzzing or pulsating sensation.

The parameters of pulse frequency, pulse width and pulse amplitude were varied

from minimum to maximum rates of the chosen TENS MODE (acupuncture

TENS) to demonstrate the range to the subjects. The rate was varied (because each

patient/subject felt and experienced each of these parameters differently) until the

level that was most comfortable to the subject and which did not produce motor

contraction was found. When the subject ceased to feel the stimulus after a few

minutes probably because of nervous accommodation the output intensity was

turned up until some strong sensation was felt again.

4. Duration of TENS Application

Each subject received a total of 1 hour of Acupuncture TENS per treatment

session. This added up to 3 hours of TENS treatments per week which amounted

to 30 hours for the 10 weeks the study lasted.

B. Group B (Control or Sham Acupuncture Tens)

The 32 subjects that fell into this group were available as control group. The sham

TENS application followed the same procedure of application except that the sham

TENS was not put on for that one hour that the treatment lasted. To ensure that the

participants were not biased they were not told that the TENS modality on them

were just a mere sham. The VAS scores before and after the application of the

sham TENS were taking from the patients and appropriately recorded. The

subjects positioning and other procedural formalities were the same as described

for Group A above.

Figure: Patient undergoing TENS Treatment

Figure 6: Showing the TENS Electrodes Placement from the Nerve Root Down the

Route of Sciatic Nerve during Research Work.

Figure 7: Showing the Alternative Positioning Of the Electrodes during This

Research Work to Make Sure the Sciatica Path Is Well Covered

A patiet und ergoig TENS Treatment FIG:

A patiet undergoig TENS Treatment FIG:

Figure 7: Same Patient Unzdergoing TENS Treatment for Sciatica with

Alternative Positioning

3 .8 Procedure for data collection

A formal request was made to the Management of Landmark Physiotherapy

Clinic, Nnewi for their patients to be made available for the research study, and

this was promptly granted. Also Ethical Approval was sought from Institutional

Review Committee of the Nnamdi Azikiwe University Teaching Hospital, Nnewi.

Informed consent was obtained before they participated in the study. The Visual

Analogue scale developed by Ali et al (1983) is a subjective pain assessment

parameter used in determining the patients‘ level of pain. It is calibrated from

0cm-10cm. the 10cm represents while 0cm represents no pain.

3.9 Procedure for Data Analysis

The subjective pain assessment before and after every two weeks sessions of

treatments were obtained using the VAS. The Visual Analogue Scale (VAS) was

presented and described to participating subjects who were instructed to describe

their level of pain by signifying a number on VAS. By this procedure the mean pre

and post VAS scores was obtained for the experimental subjects (Group A) for the

2nd

, 4th

, 6th, 8th

, and 10th

weeks. The baseline pre treatment and post treatment

VAS scores was taking and recorded for all the participants because it will

constitute the basis of comparison with subsequent VAS score readings. It ran like

that for the 10 weeks that the study lasted, making a total of five VAS readings.

The SPSS software package was applied for data analysis, while the graphical

presentations were done with sigma plot 5.0 as developed by SPSS Company. The

student t-test was used to analyze the pre and post mean visual analogue scale

scores for test and control subjects, while the independent student t-test was used

to compare between the test and control subjects. The same method of data

collection and analysis was employed for the subjects in the control group.

Statistical level of significance was set at P <0.05

CHAPTER FOUR

4.0 RESULT AND DISCUSSIONS

4.1 RESULT:

Table1. Baseline Characteristics of the Groups Evaluated at Initial Assessment

Total number number mean duration mean body mean

No of males of females age of symptoms wt kg height

(n) (nm) (nf) years+SD days(d+SD) (W+SD) (M+SD)

Group A 40 24 16 28+15.22 82.5+89.72 55.8+17.64 1.40+0.14

Group B 32 16 16 41.81+18.92 180.75+93.33 59.06+8.51 1.43+0.098

4.1.1 Summary of Table 1

The baseline characteristics of patients were presented in Table 1. Of the total of 72

patients that participated in the study 40 were males while 32 were females. In the test

group 40 patients participated, 24 were males while 16 were females. Their mean age was

28 +15.22 years and the mean duration of symptom was 82.5+89.72 days. The mean

weight and height were 59.8 + 17.64 kg and 1.40 + 0.14m respectively.

For the control group, of the 32 participants, 16 were males while 16 were females.

The mean age for the control group was 41.81+18.92 years mean duration of symptom

180.75 + 93.33 days, mean body weight 59.06+8.51 kg and mean height 1.43+0.098

Table2: Comparison of mean values for age, duration, baseline Visual Analogue Scale

Scores for the experimental and control participants.

Participants Age(years) Duration(weeks) Baseline VAS

X+S.D. X+S.D. X+S.D.

Experimental 30.70+15.68 11.40+12.07 6.25+2.66

Control 38.50+18.18 24.31+11.88 6.63+2.30

t-value -1.92 -4.55 -0.64

p-value 0.059 0.000* -0.523

X=mean SD=standard deviation *=significant at P<0.05

4.1.2: Summary of Table 2

In table 2 it will be noticed that the mean duration for the experimental (11.40+12.07) and

the control (24.31+11.88) were not matched hence there p-value was statistically

significant. There are possibilities that this could have influenced the outcome of this

research work. However, the mean values for age and baseline VAS for both experimental

and control were not matched hence the differences in outcome may not be attributed to

them.

Table 3: Comparing the Visual Analogue Scale scores between the experimental and

control participants at the second, fourth, sixth, eight and tenth week of treatment.

Participants 2nd

week 4th week 6

th week 8

th week 10

thweek

x+SD x+SD x+SD x+SD x+SD

Experimental (n=40) 4.56+3.02 3.65+3.46 2.98+3.31 2.68+3.26 2.65+5.50

Control (n=32) 6.06+2.29 6.19+2.13 6.38+2.49 6.00+2.10 3.25+2.19

t-value -2.37 -3.82 -4.98 -5.24 -4.47

p-value 0.020* 0.000* 0.000* 0.000* 0.000*

t-value= -4.176; p=0.000* X= mean SD= standard deviation *= significant at

P<0.05

4.1.3 Summary of Table 3

In table 3, comparisons of the experimental and control participants for the five weeks

stated above was statistically significant. For the experimental there was a steady

decline of pain intensity level from (4.56+3.02) for 2nd

week to (2.65+5.50) for 10th

week while for the control the pain intensity level was nearly unchanged until the 10th

week, this could be due to placebo effect.

Table 4: Comparison of the baseline Visual Analogue Scale scores of Experimental

participants and each of the second week, fourth, sixth, eight, and tenth week

Baseline 2

nd week 4

th week 6

th week 8

th week 10

thweek

Mean 6.25 4.58 3.65 2.98 2.68 2.63

STD 2.66 3.o3 3.46 3.31 3.26 3.25

t-value 4.67 5.84 6.07 6.73 6.85

p-value 0.000* 0.000* 0.002* 0.000* o.oo8*

t-value=6.032; p=0.010* STD: standard deviation *=significant at P<0.05

4.1.4 Summary of Table 4

There was indication of statistical significant reduction in pain intensity when the VAS scores of

experimental participants were compared for 2nd,

4th, 6

th, 8

th, and the 10

th, weeks. The level at which

the pain reduction was achieved decreased as from the sixth week. It was an indication that the

TENS effect was minimal possibly due to accommodation effect.

Table 5: comparison of the baseline Visual Analogue Scale scores of Control

participants and each of the second week, fourth, sixth, eight, and tenth week

Baseline 2

nd week 4

th week 6

th week 8

th week 10

thweek

Mean 6.25 6.06 6.19 6.38 6.00 5.50

STD 2.30 2.29 2.13 2.49 2.10 2.19

t-value 2.68 1.54 0.74 2.55 4.19

p-value 0.012* 0.133 0.442 0.016* o.ooo*

t-value =4.19; p=0.000 STD=standard deviation *= significant at P<0.05

4.1.5 Summary of Table 5

There were placebo effects on the control participants as shown in table 5, this effect

manifested fully in the 2nd

, 8th,

and the 10th,

weeks. The VAS scores were relatively

unchanged until the 10th

week.

Table 6: Comparison of the baseline Visual Analogue Scale of experimental participants

and each of the second, fourth, sixth, eight, and tenth week of treatment by gender.

Duration Baseline 2

nd week 4

th week 6

th week 8

th week 10

thweek

Male

Mean 6.20 4.20 3.50 2.40 2.00 2.30

STD 3.00 2.82 3.71 2.87 2.87 2.98

t-value 3.30 4.06 5.20 5.58 5.15

p-value 0.004* 0.001* 0.000* 0.000* o.ooo*

Female

Mean 6.30 4.95 3.80 3.55 3.35 2.95

STD 2.34 3.25 3.29 3.68 3.56 3.55

t-value 3.50 4.10 3.46 3.98 4.46

p-value 0.002* 0.001* 0.003* 0.001* o.ooo*

Male: t-value=5.15; p=0.00*, STD= standard deviation *= significant at P<0.05

female: t-value=4.46; p=0.000*

4.1.6 Summary of Table 6

In table 6, for the male experimental participants there was statistical significant

reduction in pain intensity following the application of TENS for the five weeks

studied, this is evident from the regular decline in VAS scores from the 2nd

week to

10th

week. However, from the 6th

week the rate at which the pain reduction was

achieved by TENS reduced significantly. Hence the p-values after the 6th

week though

were statistically significant were very close.

Also for the female experimental participants the same scenario played out from the

2nd

week to the 10th

week. Hence the p-value is statistically significant.

Table 7: Comparison of the baseline Visual Analogue Scale of control participants

and each of the second, fourth, sixth, eight, and tenth week of treatment by gender.

Duration Baseline 2nd

week 4th week 6

th week 8

th week 10

thweek

Male

Mean 6.13 5.63 6.38 6.25 5.88 5.38

STD 2.94 2.78 2.47 2.72 2.66 2.31

t-value 1.58 -0.62 -0.36 1.17 3.00

p-value 0.135 0.544 0.728 0.261 0.009*

Female

Mean 7.13 6.50 6.00 6.50 6.13 5.63

STD 1.31 1.63 1.79 2.31 1.41 2.13

t-value 2.18 3.44 1.18 2.34 3.22

p-value 0.046* 0.004* 0.0258 0.034* o.oo6*

Male: t-value=0.009; p=3.0 STD= standard deviation*= significant at P<0.05

Female: t-value=3.22; p=0.006*

4.1.7 Summary of table 7

In table 7, for the male control participants the VAS score level remain almost unchanged

an indication that the application of TENS did not alter the pain intensity level; however

the p-value was statistical significant in the 10th

week. This might be due to placebo

effect.For the female participants, the placebo effect was more demonstrated, there is still a

possibility that these group of patient ingested one form of analgesic medication or the

other. Hence the p-value was significant as indicated above.

Table8: Comparison of Visual Analogue Scale Scores of experimental and control

participants at the second, fourth, sixth, eight and tenth week of treatment by gender.

Participants 2nd

week 4th

week 6th

week 8th

week 10thweek

Male

Experimental 4.20+2.82 3.50+3.71 2.40+2.87 2.00+2.87 2.30+2.98

Control 5.63+2.78 6.38+2.47 6.25+2.72 5.88+2.66 5.38+2.31

t- value -1.52 -2.78 -4.12 -4.20 -3.49

p- value 0.138 0.009* 0.000* 0.000* 0.001*

Female

Experimental 4.95+3.25 3.80+3.29 3.55+3.68 3.35+3.56 2.95+3.56

Control 6.50+1.63 6.00+3.29 6.50+2.31 6.13+1.41 5.13+2.13

t-value -1.86 -2.56 -2.94 -3.19 -2.80

p-value 0.073 0.016* 0.006* 0.004* 0.009*

Male: t-value= -3.49; p=0.001* *=significant at P< 0.05

Female: t-value=-2.80; p=.009*

4.1.8 Summary of Table 8

In table 8, comparison of both experimental and control for the male and female

participants recorded the same trend. The VAS score level was statistically

significant- reduction in pain intensity- except in the 2nd

week when probably the

effect of TENS application had not be fully appreciated.

TABLE 9: Summary of Test Patients Response to TENS Application in Percentages

No of Test subject No% Comments

40 10 (25%) recovered completely

40 16(40%) recovered substantially

40 6 (15%) became worse after

TENS application

40 8(20%) showed no change

4.1.9 Summary of Table 9

In table 9, the percentage analysis was based on the outcome of initial pre visual analogue

scale scores for the 40 test subjects and the final post visual analogue scale scores for the

40 test subjects for the 10 weeks the study lasted. Those that recovered completely had zero

VAS scores after 10 weeks of TENS application. Those that recovered substantially had up

to fifty percent decline in VAS scores, while those that became worst after TENS

application had their VAS scores increased more than what it was originally. Finally, those

that showed no change did not witness any change in VAS scores.

4.1 HYPOTHESIS TESTING

HYPOTHESIS 1:

Statement - There will be no significant difference between the pain intensity scores of

experimental and control participants at the second, fourth, sixth, eight, and tenth week.

Test used statistic= independent t-test

α -value =p<0.05

t-test=-4.17

p-value= .000

Judgment- since the observed P-value is less than the α-value the hypothesis is rejected. It

was concluded that there was a significant relationship between the pain intensity of

experimental and control participants and each of the weeks.

HYPOTHESIS 2:

Statement- There will be no significant difference between the baseline pain intensity

scores of experimental and each of the second, fourth, sixth, eight, and tenth week.

Test statistics used-Student t-test.

α- value= p<0.05.

t-value= 6.85

p-value= 0.008

Judgment-since the observed p-value is less than the α-level the hypothesis is not accepted.

It was concluded there was a significant relationship between the baseline pain intensity

and experimental participants.

HYPOTHSIS 3:

Statement- There will be no significant difference between the baseline pain intensity

scores of control participants and each of the second, fourth, sixth, eight, and tenth week.

Test statistics used = students t-test

α-value = p<0.05

t- value = 0.74

\p-value = 0.442

Judgment- since the observed P-value was more than the α-level the hypothesis is accepted.

It was concluded there was no significant relationship between the baseline pain intensity

and control participants.

HYPOTHESIS 4:

Statement - There will be no significant difference between the baseline pain intensity of

experimental participants and each of the second, fourth, sixth, eight, and tenth week by

gender.

Test statistic used- independent t-test

α-value:=p<0.05

t-value = 5.15, p=.000 (male)

p –value = 4.46 p=0.000(female)

Judgment- since the observed P-values were less than the α-level the hypothesis is not

accepted. It was concluded that there were significant differences between the baseline pain

intensity and experimental participants for both male and female participants.

HYPOTHESIS 5:

Statement = There will be no significant difference between the baseline pain intensity of

control participants and each of the second, fourth, sixth, eight, and tenth week by gender.

Test statistic used- student t-test

α- value= P<0.05

t- value= 1.17, p=0.261(male)

t-value = .034, p=0.006(female)

Judgment-since the observed p-value is more than the α- level for males the hypothesis is

accepted and rejected for female participants because p<value was less than the α- value. It

was concluded that there was no significant relationship for male control participants and

each of the weeks while there was significant relationship for female control participants

and each of the weeks.

HYPOTHESIS 6:

Statement- There will be no significant difference between the pain intensity scores of both

experimental and control participants at the second, fourth, sixth, eight, and tenth week by

gender.

Test used- independent t-test.

α-value = <0.05

t-value = -3.49, p=0.001 (males)

t-value = -2.8 p=0.009 (females)

Judgment- since the observed p-values was less than the α-level the hypothesis is rejected

for both males and females experimental and control participants. It was concluded that

there were significant differences between the experimental and control participants by

gender.

.

4.2 DISCUSSION

Objective One:

This study evaluated the effect of Transcutanous Electrical Nerve Stimulation (TENS) in

the management of sciatic pain following intramuscular injection. In carrying out this study

it was noted that no similar research work had been done in the past concerning the effect

of Transcutaneuos Electrical Nerve Stimulation in the management of Post Injection sciatic

pain, however; the effect of TENS in managing other medical conditions were well

documented. Many studies of TENS just like this research compared the technique to

"placebo" techniques in which a TENS-like control box and electrodes was used without

delivering electric current to the patient (NSRC, 2007). Interestingly, the results of most of

these researches had not established TENS as relieving patient‘s pain condition completely

hence the use of TENS ( in combination with other therapies) were being suggested by

Abelson et al,1983 and Kumar et al,1982 . None the less previous studies provided

promising preliminary evidence but did not include clear descriptions of research design or

results. However, most of the published research works on TENS management of different

medical and surgical conditions showed conflicting results about the actual efficacy and

duration effect of TENS application. Several factors which contributed to these conflicting

reports included but not limited to the following: unspecified stimulation parameters,

stimulation variables not controlled during the research process, different outcome

measures, different electrodes placements, lack of placebo control, patients presenting at

different stages in disease process, and failure to monitor or document patient compliance.

(Kumar et al, 1982; Levy, et al, 1987; Mannheimer et al 1978; Mannheimer, et al 1978;

Reitman and Esses, 1995; Robinsion, 1996). The outcome of this study would bring to light

the importance of one of the physical therapy modalities –TENS- commonly used in pain

management in managing Post injection sciatic pain.

The analysis of the objective one had shown that the effect of TENS on the experimental

participants was statistically significant- that is to say that it reduced the post injection

sciatic pain after ten weeks of its application in 65% of experimental participants. This

study agreed with previous studies by various researchers on the efficacy of TENS in pain

management (Johnson et al; 1991b, Oya et al, 2004; Fisbian et al 1996). Also the study by

White et al (1999) showed that TENS effectively decreased pain in 64 adults with disc

herniation related sciatic pain by 23%, while the oral drugs intake was reduced by 15%.

This work was done on the assumption that since TENS had been confirmed to be widely

used in managing various kinds of pain like pain from dental procedures (Meechan et al;

1998, Soo-Ampn et al,1997;Harvey, et al, 1995 ); osteoarthritis of the knee ( Cheing et al,

1995); Angina pectoris (Mannheimer et al 1989); Low back pain (Jordan et al, 1997) and

chronic pain of all sorts (Carrol et al, 2001); Peripheral neuropathy (kumar et al, 1997);

Rheumatoid arthritis ( Kumar,1982), et cetera that it could also be beneficial in managing

Post Injection Sciatic Pain.

The research also showed that the effect of TENS on the patients sciatic pain started to

depreciate after sixth week of application —the pain intensity level as was shown by the

fairly unchanged VAS scores irrespective of TENS application on the experimental

participants. This was supported by the scientific finding that the benefit of TENS tends to

fall with time (Loser et al; 1975: Taylor et al; 1989: Bates et al; 1980). The depreciation in

Value-effect of TENS might be due to the adaptation of the nervous system to regular

repetitive stimuli (Thompson, 1987; and Pomeranze et al 1987). The clinical implication of

this finding is that TENS application should be stopped when it ceases to alter the course of

pain. The clinical implication of this is that when TENS is applied for a long time nerve

accommodation usually take place and that may affect the general efficacy of TENS in pain

relief. To overcome this, Frampton (1998) suggested swinging between continuous and

burst TENS modes during treatment. This situation of nerve adaptation and

accommodation accounted for why some period after TENS is switched on, patient

complained that he/she was not feeling the buzzing or pulsating sensation well enough.

Another major finding was that the parameters of pulse width, pulse frequency and

Intensity which various combinations constitute the four treatment modes of conventional

TENS, Acupuncture like TENS, Brief /Intense TENS and Burst/Train TENS are

commonly not specified or not kept constant among patients within a given study (Kathlen,

2003) . This study choose the Acupuncture like TENS as the mode of treatment just as had

been stated above, the parameters were constantly been varied for maximum effect.

Johnson et al (1991c) reported that individual patients used a specific pulse frequency but

consistently there was a significant variation in the pulse frequency used by different

patients. The result revealed that the effect of TENS did not start immediately that it

needed to be applied for some time before its accumulative effect would be felt, this is in

line with the experimental work of Sjolund et al,1979, Woolfe et al, 1981.

The effect of TENS on control participants (sham) which was tested was found not to had

a significant relieve of patients‘ pain. Many studies of TENS compared the technique to

"placebo" techniques in which a TENS-like control box and electrodes were applied

without actually delivering electric current to the patient. However, it was found that

though a sham TENS some patients felt some level of pain relief as this could be explained

by a placebo factor arising from patients assumption of being treated –this is in line with

Kathlen,2003 who postulated that TENS had been known to have significant placebo

effect. The pain relief effect could equally be attributed to the possibility of patients

ingesting pain relief medications during the period of sham TENS application.

Objective Two:

The analysis of objective two revealed that the effect of sham TENS application on male

control participants did not bring about significant relief or reduction of patients‘ pain for

the ten weeks the study lasted. While in the female control participants the pain relief was

significant. It is worthy to note that any pain relief achieved during sham TENS application

could be due to some other factors outside placebo effect such as ingesting of pain killers

during the treatment period.

Interestingly, for the female and male participants in the experimental group there was

statistical significant reduction in post injection sciatic pain throughout the period of TENS

application. It showed that pain reduction with TENS may not be attributed to gender

influence. Though there was dearth of literature to either support or counter this finding

however; subtle genetic and psychological variations are increasingly recognized to

contribute to pain and analgesic efficacy and safety. The influence of sex on this

relationship remains poorly understood, particularly in humans. The issue is complicated

by the overlay of gender onto physical sex, and its associated stereotypes and expectations.

Women appear to use more pain-relieving medications than men; however, it remains

unclear whether these observations represent true differences in analgesic usage patterns, or

reporting bias. Differences in analgesic efficacy relating to body composition, metabolism

and hormonal profiles have been demonstrated. Psychological and social elements of

gender have also been associated with altered pain experiences and analgesic use profiles,

albeit with significant individual variations. Intra-group differences may ultimately prove

more important than sex differences. Further research may unravel the various threads

linking gender and sex effects on analgesia with the aim of individualizing analgesia to

optimize pain relief. (Wesenfeld-Hallin, 2005)

Researchers have confirmed that gender influences not just the perception of pain, but also

how much we talk about it, how we cope with it, the medications we use, and even the

dosage doctors prescribe. To assist with proper rehabilitation, scientists are investigating

the circumstances under which men and women differ when dealing with pain. However,

progress in this area is hampered by a lack of adequate guidelines for conducting such

studies. To navigate this sensitive area, a group of leading researchers in this field have

begun to formulate a set of procedures. These improvements may lead to:

1. The prospect of gender-specific medications for pain treatment.

2. A better understanding of the prevalence of certain pain conditions among women.

A striking discovery is that the painkiller morphine works differently in the brains and

spinal cords of males and females.(Neuroscience, 2005)

In this study no attempt was made to compare the effect of age of patients and duration of

symptoms on the TENS pain relieving effect, this was because the duration of symptoms

for both participants for both the experimental and control subjects were not matched.

However, the difference between the mean age of experimental and control participants

was not statistically significant (p>0.05) while that of duration of symptom was found to be

statistically significant (p<0.05) and possibilities exist that this difference might have

influenced the outcome of this research work.

CHAPTER FIVE

5.0 SUMMARY, CONCLUSION AND RECOMMENDATION

5.1 Summary

Post injection sciatic pain results from injury to the sciatic nerve during gluteal

intramuscular injection. The sciatic pain can affect only one side of the lower limb; the pain

may be dull, sharp, or accompanied by intermittent shocks of shooting pain beginning in

buttock, travelling downward into the back or side of the thigh and /or leg. Sciatic pain then

may extend below the knees and be felt in the feet. The aim of this study was to determine

if TENS could have beneficial effect in the management of post injection sciatic pain.

Literature on the TENS management of post injection sciatic pain were not readily

available, however; empirical studies on the efficacy of TENS in managing so many

medical and orthopedic conditions were well documented and conspicuously cited in this

work. Most of the results from literature review showed conflicting evidences on the

efficacy of TENS in managing those conditions (Dego et al, 1990; Jordan et al 1995;

Okada et al, 2001; Soomro et al; Grief et al 2002). Hence the gap created by this conflict

was what aroused the interest in this research work.

This study used cross-sectional experimental design. Ethical approval was sought from

the Institutional Review Committee of the Nnamdi Azikiwe University Teaching Hospital,

Nnewi and Landmark Physiotherapy Clinic, Nnewi before the study commenced.

The seventy two participants comprised forty experimental and thirty two control

participants and their selection into groups were randomized accordingly. Visual Analogue

Scale (VAS) was used to determine participants‘ pain intensity and for data collections

while the (SPSS 13.0) statistical software was used for data analysis.

The outcome of the study showed that there was statistically significant reduction in pain

intensity of the experimental participants at the various weeks tested after the application of

TENS while there was no statistically reduction in pain significant difference for the

control participants. The acupuncture like TENS from this outcome proved more effective

in managing post injection sciatic pain than the placebo TENS. The experimental

participants by gender were statistically significant for both male and female participant

while that of control participants was not statistically significant. Of all the forty

experimental participants 10(25%) recovered completely, 16(40%) recovered substantially,

6(15%) became worse after TENS application, and 8(20%) showed no change.

5.2 Conclusions

Based on the outcome of this research work the following conclusions are hereby

made:

1. there was statistical significant reduction in pain intensity of experimental

participants after ten weeks of TENS application .

2. there was no statistical significant reduction in pain intensity of control

participants after ten weeks of TENS application.

3. there was statistical significant difference in pain intensity level when the

experimental and control participants were compared.

4. there was statistical significant reduction in pain intensity level for the

experimental participants by gender.

5. there was no statistical significant difference in pain intensity level for male

control participants while there was significant difference for female participants.

The significant noticed may be due to placebo effect resulting from feeling of

being treated.

6. there was statistical significant difference in the pain intensity level of the

experimental and control participants by gender when compared.

7. the effect of TENS varies with the duration of TENS application

8. the study revealed that 65% of experimental participants comprising 25% who

had complete relief and 40% who had up to 50% relief from their initial pain

intensities benefitted from Acupuncture TENS treatment.

9. the above shows that TENS application where it is indicated does not guarantee

100% success in pain relief.

5.3 Recommendations

Based on the above results and conclusions the following recommendations are hereby

made:

1. TENS can be used as an adjunct in the management of post injection

sciatic pain for more optimal result..

2. TENS can be used on post injection sciatic patients irrespective of gender.

3. Sham TENS cannot be used to relieve patients post injection sciatic pain.

4. TENS should be compared with other physiotherapeutic modalities to determine

the one it should be combined with in managing post injection sciatic pain.

5 .More studies are advised with more participants so that findings in this study can

be further verified.

6. The age and duration of symptoms should be matched for the different participants

in future studies in order to get more realistic outcome.

8. Future studies should focus on determining TENS optimal frequency, intensity

and pulse width that suites each individual.

9. The effect of TENS on gender should be further studied in order to determine the

gender influence if any.

5.4 Limitations of Study:

This study was limited by the following factors:

1. Low sample size which arose from delimitation of the study to only patients

referred for physiotherapy at one clinical setting.

2. It might be possible that subjects that participated in the test group still

ingested one form of analgesic medication or the other.

3. Pre and Post treatment VAS measurement is a subjective method of pain

assessment and patients might not have reported the level of pain felt correctly.

4. the duration of symptoms were not matched hence there exists a possibility that

it might have affected the outcome of this research work.

5. the non matching of the ages of the participants might have affected the

outcome of the research work.

6. the treatment modes of intensity, frequency and pulse width which varied

amongst participants did not provide for equal assessment of participants using

a uniformed parameter

5.5 Clinical Implications of Study:

The clinical implication of these findings is that Accupunture TENS can be recommended

for the management of post injection sciatic pain and that its pain reduction ability is

without any form of gender bias. Future researches should address some of the issues raised

in the limitation of the study as highlighted above . This entailed that if the post injection

sciatic pain is reduced then the amount of medications ingested by patients will definitely

reduce and the quality of life of the patient will be enhanced.

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INFORMED CONSENT

My name is Okonkwo, Uchenna Prosper. I am a Masters Degree student of the Department of

Medical Rehabilitation, Faculty of Health Science and Technology, University of Nigeria, Enugu

campus.

I am carrying out a research on the effect of TENS in the Management of Sciatica caused by

Intramuscular Injection. The result of the study will hopefully help not only physiotherapists but the

entire medical community in managing post injection sciatic pain better.

You have been chosen as one of those to participate in the clinical study. I will apply TENS on your

pain for a maximum of ten weeks. The process of using TENS won’t be harmful to your body as it

is a non- invasive pain reliving treatment modality widely used in managing pain by

physiotherapists. Be assured that all the information I receive from you will be treated with utmost

confidentiality.

Participation is voluntary without any significant financial inducement and so you reserve the right

to withdraw from participation if at any time you don’t feel safe or comfortable with the

experimental procedure.

I shall greatly appreciate your taking part in the study.

Consent: Now that the study has been explained to me and I fully understand the content of the

study process, I will be willing to take part.

………………………………………………. ……….……………………………..

Signature/thumbprint of participant. Signature of the researchers

Date …………………………… Date …………………………

………………………………… Signature of the Witness

Date ………………

In case of enquiries/complaints, contact

Samuel Ibeneme, PH,D.

Head, Department of Medical Rehabilitation (Physiotherapy)

Faculty of Health Sciences and Technology University of Nigeria

Enugu Campus

APPENDIX 1 WEEKLY VAS DATA FOR GROUP A PATIENTS PTt1: Age 31 Sex m DS 7 Months

Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 2 3 2 2 0 0 0 0 0 0

VAS POST 1 2 1 0 0 0 0 0 0 0

Pt 2: Age 32 Sex M DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 3 3 3 1 0 0 0 0 0 0

VAS POST 1 1 1 0 0 0 0 0 0 0

Pt 3: Age 33 Sex M DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 2 1 1 0 0 0 0 0 0 0

VAS POST 1 0 0 0 0 0 3 0 0 0

Pt4: Age 17 Sex f DS 11 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 2 2 1 1 2 1 0 0 0 0

VAS POST 0 1 3 0 0 0 3 0 0 0

Pt 5: Age 55 Sex F DS 6 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 7 7 10 9 8 7 7

VAS POST 9 8 7 10 9 10 8 9 10 9

Pt 6: Age 40 Sex M DS 4 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 8 5 7 5 4 6 7 4 4

VAS POST 3 9 7 8 3 4 7 2 3 4

Pt 7: Age 47 Sex M DS 4 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 5 4 3 3 4 3 4 4 3

VAS POST 4 3 2 2 1 2 2 2 3 3

Pt 8: Age 28 Sex F DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 6 5 5 6 5 3 2 2 0 0

VAS POST 4 4 3 2 2 1 1 0 0 0 Pt 9: Age 41 Sex M DS 12 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 10 7 9 8 8 5 3 3 2 2

VAS POST 7 4 5 8 3 2 1 2 0 1

Pt 10: Age 38 Sex M DS 1 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 5 4 4 3 2 3 2 3 2 3

VAS POST 4 5 3 1 1 2 1 1 1 1

Pt 11: Age 68 Sex F DS 2 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 8 5 6 4 6 4 5 3 2

VAS POST 6 7 6 3 4 3 3 2 1 1

Pt 12: Age 44 Sex F DS 15 days Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 10 8 7 5 3 2 2 3 2 2

VAS POST 7 9 2 3 1 0 1 2 1 1

Pt 13: Age 22 Sex M DS 4 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 7 6 5 3 2 2 1 1 1

VAS POST 5 6 3 2 1 2 2 1 1 1

Pt 14: Age 37 Sex X DS 2 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 4 3 2 1 2 2 2 2 2 2

VAS POST 1 1 1 1 1 1 1 1 1 1

Pt 15: Age 13 Sex F DS 3 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 3 4 3 3 4 4 2 2 3

VAS POST 7 3 4 3 4 4 2 2 3 2

Pt 16: Age 17 Sex F DS 3 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 8 8 7 6 4 4 5 4 4 4

VAS POST 3 4 5 4 2 2 4 2 2 2

Pt 17: Age 11 Sex M DS 2 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 9 9 10 9 10 10 9 9 10

VAS POST 9 8 10 10 10 10 10 10 9 10

Pt 18: Age 11 Sex F DS 4 days Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 9 10 10 10 9 9 9 9 10

VAS POST 7 10 10 9 9 10 10 10 10 10

Pt 19: Age 16 Sex M DS 5 days Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 10 8 7 7 4 3 4 5 4 1

VAS POST 5 4 5 4 1 2 1 2 3 3

Pt 20: Age 13 Sex F DS 40 days Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 5 5 4 3 5 5 5 5 5 5

VAS POST 5 4 5 4 5 5 5 6 6 4

Pt 21: Age 31 Sex M DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 2 3 2 2 0 0 0 0 0 0

VAS POST 1 2 1 0 0 0 0 0 0 0

Pt 22: Age 32 Sex M DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 3 3 3 1 0 0 0 0 0 0

VAS POST 1 1 1 0 0 0 0 0 0 0

Pt 23: Age 33 Sex M DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE

2 1 1 0 0 0 0 0 0 0

VAS POST

1 0 0 0 0 0 0 0 0 0

Pt 24: Age 17 Sex F DS 11 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 2 2 1 1 2 1 0 0 0 0

VAS POST 0 1 3 0 0 0 3 0 0 0

Pt 25: Age 55 Sex F DS 6 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 7 7 10 9 8 7 7

VAS POST 9 8 7 10 9 10 8 9 10 9

Pt 26: Age 40 Sex M DS 4 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 8 5 7 5 4 6 7 4 4

VAS POST 3 9 7 8 3 4 7 2 3 4

Pt 27: Age 47 Sex M DS 4 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 5 4 3 3 4 3 4 4 3

VAS POST 4 3 2 2 1 2 2 2 3 3

Pt 28: Age 28 Sex F DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 6 5 5 6 5 3 2 2 0 0

VAS POST 4 4 3 2 2 1 1 0 0 0

Pt 29: Age 41 Sex M DS 12 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 10 7 9 8 8 5 3 3 2 2

VAS POST 7 4 5 8 3 2 1 2 0 1

Pt 30: Age 38 Sex M DS 1 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 5 4 4 3 2 3 2 3 2 3

VAS POST 4 5 3 1 1 2 1 1 1 1

Pt 31: Age 68 Sex 7 DS 2 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 8 5 6 4 6 4 5 3 2

VAS POST 6 7 6 3 4 3 3 2 1 1

Pt 32: Age 44 Sex F DS 15 days Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 10 8 7 5 3 2 2 3 2 2

VAS POST 7 9 2 3 1 0 1 2 1 1

Pt 33: Age 22 Sex M DS 4 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 7 6 5 3 2 2 1 1 1

VAS POST 5 6 3 2 1 2 2 1 1 1

Pt 34: Age 37 Sex X DS 2 Months

Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 4 3 2 1 2 2 2 2 2 2

VAS POST 1 1 1 1 1 1 1 1 1 1

Pt 35: Age 13 Sex F DS 3 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 3 4 3 3 4 4 2 2 3

VAS POST 7 3 4 3 4 4 2 2 3 2

Pt 36: Age 17 Sex F DS 3 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 8 8 7 6 4 4 5 4 4 4

VAS POST 3 4 5 4 2 2 4 2 2 2

Pt 37: Age 11 Sex M DS 2 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 9 9 10 9 10 10 9 9 10

VAS POST 9 8 10 10 10 10 10 10 9 10

Pt 38: Age 11 Sex F DS 4 days Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 9 10 10 10 9 9 9 9 10

VAS POST 7 10 10 9 9 10 10 10 10 10

Pt 39: Age 16 Sex M DS 5 days Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 10 8 7 7 4 3 4 5 4 1

VAS POST 5 4 5 4 1 2 1 2 3 3

Pt 40: Age 13 Sex F DS 40 days Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 5 5 4 3 5 5 5 5 5 5

VAS POST 5 4 5 4 5 5 5 6 6 4

APPENDIX II WEEKLY VAS DATA FOR GROUP B PATIENTS (CONTROL GROUP) Pt 1: Age 55 Yrs Sex F DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 8 9 7 8 9 10 8 9 10

VAS POST 8 8 9 9 8 10 9 8 10 9

Pt 2: Age 60 Sex M DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 3 3 3 4 4 3 3 3 4 3

VAS POST 3 2 4 5 4 3 3 4 4 4

Pt 3: Age 25 Sex M DS 6 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 2 2 3 3 3 4 4 3 3 2

VAS POST 2 3 4 4 3 5 4 3 2 2

Pt 4: Age 55 Sex M DS 3 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 3 3 3 4 4 3 3 3 2 3

VAS POST 3 3 4 4 4 3 3 2 2 3

Pt 5: Age 55 Sex F DS 6 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 7 7 6 7 8 8 8 7

VAS POST 7 7 7 6 7 8 7 8 7 7

Pt 6: Age 20 Sex M DS 3 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 8 8 8 8 8 8 8 7 7 8

VAS POST 8 8 7 7 9 8 7 7 6 7

Pt 7: Age 15 Sex F DS 4 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 7 7 5 6 6 5 5 5

VAS POST 7 8 6 5 6 7 5 6 4 4

Pt 8: Age 25 Sex M DS 6 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 9 10 10 9 9 8 8 9 9

VAS POST 8 10 9 10 9 8 7 9 7 8

Pt 9: Age 53 Sex M DS 6 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 6 4 5 6 4 5 5 6 5 5

VAS POST 4 5 6 4 5 4 4 5 3 4

Pt 10: Age 20 Sex F DS 11 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 5 6 4 3 4 5 6 7 5 5

VAS POST 2 4 2 3 4 4 4 6 4 2

Pt 11: Age 65 Sex F DS 9 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 8 8 9 8 8 8 7 7

VAS POST 8 8 7 8 8 9 7 7 6 7

Pt 12: Age 15 Sex M DS 12 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 9 8 9 8 9 9 10 9 9

VAS POST 9 8 9 7 7 9 8 9 8 8

Pt 13: Age 49 Sex F DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 6 6 5 5 6 5 5 7

VAS POST 6 6 5 5 6 6 5 4 6 6

Pt 14: Age 37 Sex M DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 9 7 9 9 9 6 9 8 8

VAS POST 5 6 5 10 10 10 5 8 7 7

Pt 15: Age 51 Sex F DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 8 8 9 6 5 4 5 5 5

VAS POST 8 7 9 6 5 4 5 5 5 4

Pt 16: Age 16 Sex F DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 6 5 6 7 7 5 5 4 5 7

VAS POST 5 4 7 6 6 4 4 5 4 6

Pt 17: Age 55 Yrs Sex F DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 8 9 7 8 9 10 8 9 10

VAS POST 8 8 9 9 8 10 9 8 10 9

Pt 18: Age 60 Sex M DS 7 Months

Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 3 3 3 4 4 3 3 3 4 3

VAS POST 3 2 4 5 4 3 3 4 4 4

Pt 19: Age 25 Sex M DS 6 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 2 2 3 3 3 4 4 3 3 2

VAS POST 2 3 4 4 3 5 4 3 2 2

Pt 20: Age 55 Sex M DS 3 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 3 3 3 4 4 3 3 3 2 3

VAS POST 3 3 4 4 4 3 3 2 2 3

Pt 21: Age 55 Sex F DS 6 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 7 7 6 7 8 8 8 7

VAS POST 7 7 7 6 7 8 7 8 7 7

Pt 22: Age 20 Sex M DS 3 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 8 8 8 8 8 9 8 7 7 8

VAS POST 8 8 7 7 9 8 7 7 6 7

Pt 23: Age 15 Sex F DS 4 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 7 7 5 6 6 5 5 5

VAS POST 7 8 6 5 6 7 5 6 4 4

Pt 24: Age 25 Sex M DS 6 Weeks Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 9 10 10 9 9 8 8 9 9

VAS POST 8 10 9 10 9 8 7 9 7 8

Pt 25: Age 53 Sex M DS 6 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 6 4 5 6 4 5 5 6 5 5

VAS POST 4 5 6 4 5 4 4 5 3 4

Pt 26: Age 20 Sex F DS 11 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 5 6 4 3 4 5 6 7 5 5

VAS POST 2 4 2 3 4 4 4 6 4 2

Pt 27: Age 65 Sex F DS 9 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 8 8 9 8 8 8 7 7

VAS POST 8 8 7 8 8 9 7 7 6 7

Pt 28: Age 15 Sex F DS 12 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 9 8 9 8 9 9 10 9 9

VAS POST 9 8 9 7 7 9 8 9 8 8

Pt 29: Age 49 Sex F DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 7 7 6 6 5 5 6 5 5 7

VAS POST 6 6 5 5 6 6 5 4 6 6

Pt 30: Age 37 Sex M DS 5 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 9 7 9 9 9 6 9 8 8

VAS POST 5 6 5 10 10 10 5 8 7 7

Pt 31: Age 51 Sex F DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 9 8 8 9 6 5 4 5 5 5

VAS POST 8 7 9 6 5 4 5 5 5 4

Pt 32: Age 16 Sex F DS 7 Months Weeks 1 2 3 4 5 6 7 8 9 10

VAS PRE 6 5 6 7 7 5 5 4 5 7

VAS POST 5 4 7 6 6 4 4 5 4 6

Appendix iii xii GROUP A INTITIAL AND FINAL VAS SCORES

Patients Age Sex Ds Vas pre Vas post Vas pre Vas post

Pt1 41 M 12 weeks 10 7 2 1

Pt2 32 M 5 Months 3 1 0 0

Pt3 13 F 3 weeks 7 7 3 2

Pt4 17 F 11 Months 2 1 0 0

Pt5 14 M 4 months 7 9 8 9

Pt6 40 M 4 weeks 7 3 4 4

Pt7 47 M 4 weeks 7 4 3 3

Pt8 28 M 4 months 6 4 0 0

Pt9 41 M 12 weeks 10 7 2 1

Pt10 11 M 2 weeks 7 9 10 10

Pt11 68 F 2 weeks 7 6 2 1

Pt12 11 F 4 days 10 5 10 10

Pt13 22 M 4 months 9 5 1 1

Pt14 37 F 2 months 4 1 2 1

Pt15 11 M 2 weeks 7 9 10 10

Pt16 17 F 3 weeks 8 3 4 2

Pt17 47 M 4 weeks 7 4 3 3

Pt18 11 F 2 days 10 5 10 10

Pt19 16 M 2 days 10 5 1 3

Pt20 23 F 40 days 5 5 5 4

Pt21 12 M 2 weeks 2 1 0 0

Pt22 32 M 5 months 3 2 0 0

Pt23 33 M 11 months 2 0 0 0

Pt24 17 F 11 months 2 1 0 0

Pt25 14 M 4 months 4 9 8 9

Pt26 40 M 4 weeks 7 3 4 4

Pt27 38 M 1 weeks 5 4 3 1

Pt28 28 M 4 months 6 4 0 0

Pt29 33 M 5 months 2 1 0 0

Pt30 38 M 1 weeks 5 4 3 1

Pt31 68 F 2 weeks 7 6 2 1

Pt32 44 F 15 weeks 10 7 2 1

Pt33 22 m 4 months 9 5 1 1

Pt34 27 M 2 months 4 1 2 1

Pt35 13 F 13 weeks 4 1 2 1

Pt36 17 F 3 weeks 7 9 10 10

Pt37 12 M 2 weeks 2 1 0 0

Pt38 44 F 15 weeks 10 7 2 1

pt39 16 M 5 days 10 5 1 3

Pt40 23 F 40 days 5 5 5 4

APPENDIX III

Patients Age Sex Ds Vas pre Vas post Vas pre Vas post

Pt 1 55 F 6 Months 7 7 7 7

Pt 2 60 M 7 Months 3 3 3 4

Pt 3 25 M 6 Months 2 2 2 2

Pt 4 55 M 3 Months 3 3 3 3

Pt 5 49 F 7 Months 7 6 7 6

Pt 6 20 M 3 Weeks 8 8 8 7

Pt 7 15 F 4 Weeks 7 7 5 4

Pt 8 25 M 3 Weeks 9 8 9 4

Pt 9 53 M 6 Months 6 4 5 4

Pt 10 20 F 11 Months 5 2 5 3

Pt 11 51 F 7 Months 9 8 5 4

Pt 12 15 M 12 Months 9 9 9 8

Pt 13 49 F 7 Months 7 6 7 6

Pt 14 37 M 5 Months 9 5 8 7

Pt 15 20 M 3 Weeks 8 8 8 7

Pt 16 69 F 7 Months 6 5 7 6

Pt 17 55 F 5 Months 9 8 10 9

Pt 18 69 M 7 Months 3 3 3 4

Pt 19 25 M 6 Months 2 2 2 2

Pt 20 55 M 3 Months 3 3 3 3

Pt 21 55 F 6 Months 7 7 7 7

Pt 22 37 M 5 Months 9 5 8 7

Pt 23 15 F 4 Months 7 7 5 4

Pt 24 25 M 3 Months 9 8 9 8

Pt 25 53 M 6 Months 6 4 5 4

Pt 26 20 F 11 Months 5 2 5 3

Pt 27 65 F 9 Months 7 8 7 7

Pt 28 15 M 12 Months 9 9 9 8

Pt 29 55 F 5 Months 9 8 10 9

Pt 30 65 F 9 Months 7 8 7 7

Pt 31 51 F 7 Months 9 8 5 1

Pt 32 69 F 7 Months 6 5 7 6

VAS: Visual Analogue test

Initial VAS: Reading on the 1st day of treatment

Final VAS: Reading on the last day of the visit.

DS: Duration of symptom

Pt: Patient.

APPENDIX V

WEIGHT AND HEIGHT MEASUREMENTS FOR 40 TEST SUBJECTS (GPA)

Weights (M) Mean+SD Ht (M) Mean+SD

1. 60 1.4 2. 75 1.6 3. 72 1.5 4. 45 1.4 5. 59 1.3 6. 74 1.6 7. 77 1.6 8. 61 1.3 9. 76 1.6 10. 71 1.6 11. 70 1.5 12. 72 1.5 13. 50 1.4 14. 57 1.3 15. 35 1.3 16. 32 1.3 17. 30 1.1 18. 30 1.3 19. 35 1.4 20. 31 1.2 21. 31 1.2 22. 35 1.4 23. 30 1.3 24. 30 1.1 25. 32 1.3 26. 35 1.3 27. 57 1.3 28. 50 1.4

29. 72 1.5 30. 70 1.5 31. 71 1.6 32. 76 1.6 33. 61 1.3 34. 77 1.6 35. 74 1.6 36. 59 1.3 37. 49 1.4 38. 72 1.5 39. 75 1.6 40. 60 1.4 T0tal 2232 55.8 STD 55.8+17.635 1.395+0.14641

APPENDIX Vi

WEIGHT AND HEIGHT MEASURREMENTS FOR 32 CONTROL SUBJECTS (GPB)

WEIGHTS (M) MEAN (+SD) HT mean (+SD) 1. 55kg 1.4m 2. 57kg 1.3m 3. 70kg 1.5m 4. 69kg 1.4m 5. 60kg 1.5m 6. 77kg 1.6m 7. 52kg 1.3m 8. 53k 1.m 9. 7kg 1.5m 10. 64kg 1.6m 11. 57kg 1.4m 12. 47kg 1.3m 13. 63kg 1.4m 14. 52kg 1.3m 15. 56kg 1.5m 16. 46kg 1.4m 17. 46kg 1.4m 18. 56kg 1.5m 19. 52kg 1.3m 20. 63kg 1.4m 21. 47kg 1.3m

22. 57kg 1.4m 23. 64kg 1.6m 24. 67kg 1.5m 25. 53kg 1.4m 26. 52kg 1.3m 27. 77kg 1.6m 28. 60kg 1.5m 29. 69kg 1.4m 30. 70kg 1.5m 31. 57kg 1.3m 32. 55kg 1.4m Total 1890 45.6 STD 59.06 +8.512 1.43+0.098