THE EFFECTS OF MUD PACK THERAPY VERSUS HOT PACK …

ABSTRACT

THE EFFECTS OF MUD PACK THERAPY VERSUS HOT PACK TREATMENT TO IMPROVE FUNCTIONALITY AND

DECREASE PAIN IN OLDER ADULTS SUFFERING WITH KNEE

OSTEOARTHRITIS

Objective: The purpose of this meta-analysis is to examine the effects of

mud pack therapy versus hot pack treatment to improve functionality and decrease

pain in older adults suffering with knee osteoarthritis.

Methods: Studies were analyzed to compare the increase in function and

decrease in pain with the use of mud pack therapy and hot pack treatment. The

studies were meta-analyzed to determine the novel intervention’s effect size and

homogeneity.

Results: Four studies were included in this meta-analysis. A medium effect

size was determined to improve function and decrease pain with the use of mud

pack therapy. Homogeneity was noted among the studies for function, while

studies were heterogeneous regarding the effects of pain in older adults suffering

with knee osteoarthritis.

Conclusion: This meta-analysis concludes mud pack therapy has a greater

treatment effect size to increase functionality and decrease pain in older adults

suffering with knee osteoarthritis compared to hot pack treatment.

Study Design: A meta-analysis of random control trial studies observing

the effects of mud pack therapy versus hot pack treatment to increase functionality

and decrease pain in older adults suffering from knee osteoarthritis.

Mario Ernesto Crespin May 2017

THE EFFECTS OF MUD PACK THERAPY VERSUS HOT PACK

TREATMENT TO IMPROVE FUNCTIONALITY AND

DECREASE PAIN IN OLDER ADULTS

SUFFERING WITH KNEE

OSTEOARTHRITIS

by

Mario Ernesto Crespin

A project

submitted in partial

fulfillment of the requirements for the degree of

Doctor of Physical Therapy

in the Department of Physical Therapy

College of Health and Human Services

California State University, Fresno

May 2017

APPROVED

For the Department of Physical Therapy:

We, the undersigned, certify that the project of the following student meets the required standards of scholarship, format, and style of the university and the student's graduate degree program for the awarding of the doctoral degree. Mario Ernesto Crespin

Project Author

Nupur Hajela (Chair) Physical Therapy

Jennifer Roos Physical Therapy

For the University Graduate Committee:

Dean, Division of Graduate Studies

AUTHORIZATION FOR REPRODUCTION

OF DOCTORAL PROJECT

X I grant permission for the reproduction of this project in part or in

its entirety without further authorization from me, on the

condition that the person or agency requesting reproduction

absorbs the cost and provides proper acknowledgment of

authorship.

Permission to reproduce this project in part or in its entirety must

be obtained from me.

Signature of project author:

ACKNOWLEDGMENTS

I would like to thank Dr. Nupur Hajela, Dr. Jennifer Roos, Dr. Monica

Rivera and Dr. Nicole Vitato for their support and guidance with the development

of this meta-analysis. As I earn my doctorate in physical therapy, I sincerely

express my deepest gratitude to my best friend, Jonathan de Vera, my parents, my

brother, and those I hold close to my heart for their unconditional love and

support. It gives me great pleasure to share this experience with the California

State University, Fresno, Doctor of Physical Therapy, Class of 2017 as we have

helped each other through adversity and celebrate our success collectively.

TABLE OF CONTENTS

Page

LIST OF TABLES .................................................................................................. vi

LIST OF FIGURES ................................................................................................ vii

BACKGROUND ...................................................................................................... 1

METHODS ............................................................................................................... 5

Search Strategy .................................................................................................. 5

Selection Criteria ............................................................................................... 5

Data Extraction .................................................................................................. 6

Statistical Analysis ............................................................................................ 6

RESULTS ................................................................................................................. 8

Study Characteristics ......................................................................................... 9

Synthesis of Results ........................................................................................ 10

DISCUSSION ......................................................................................................... 13

CONCLUSION ...................................................................................................... 17

REFERENCES ....................................................................................................... 18

TABLES ................................................................................................................. 22

FIGURES ............................................................................................................... 24

APPENDIX: PEDRO SCALE ............................................................................... 26

LIST OF TABLES

Page

Table 1. Study Characteristics ................................................................................ 23

LIST OF FIGURES

Page

Figure 1. Data analysis-pain ................................................................................... 25

Figure 2. Data-analysis-function ............................................................................ 25

BACKGROUND

Osteoarthritis (OA) is one of the most common clinical syndromes seen by

clinicians mainly affecting older adults and is associated with defective articular

cartilage integrity, changes of subchondral bone, and articulating joint margins.1

More than 100 different types of arthritic conditions have been identified, though

OA currently affects over 30 million people in the United States.2 Recent data

from the National Health and Nutrition Examination Survey reported

approximately 35% of women and men over the age of 60 years old are most

commonly affected with radiographic knee osteoarthritis.3-5 Currently, the lifetime

cost of symptomatic knee osteoarthritis management in the United States averages

$12,400 per person every year due to medical visits, pharmaceutical use, physical

therapy, purchase of braces, orthotics, and loss time of occupation productivity.4

Knee pain is a strongly associated subjective response with the progression of the

degenerative joint disease.1 The articular changes due to OA often lead to pain,

loss of mobility, muscle strength, impaired function, and decreased quality of

life.2-5 Dynamic balance deficits, impaired proprioception, altered postural control,

and reduced range of motion drastically increases the risk for falls among older

adults.1,6 Muscle weakness is a known risk factor for falls, and studies report a

76% decrease of eccentric quadriceps and hip muscle strength when comparing

elderly fallers and non-fallers.7

Although the etiology of knee osteoarthritis is not entirely understood, the

cause of osteoarthritis is multifactorial and several risk factors have been

identified, such as excessive weight bearing activities, traumatic events, high body

mass index, with the natural aging process being the most common predisposing

factor.1 Some studies have suggested biochemical markers of arthritis are

2 2

molecules detectable in synovial fluid that may reflect the underlying degenerative

or inflammatory response of joint disease.8,9 Increased levels of YKL-40, a

secreted glycoprotein, along with interlukin-6 and tumor necrosis factor-alpha,

cytokines released by macrophages were detected in older adults with active

rheumatoid arthritis and severe knee OA compared to healthy adults.10

Pharmacological treatment is an intervention aimed to reduce pain and

increase function for older adults suffering with symptomatic knee OA. It is

important to note non-steroidal anti-inflammatory drug (NSAID) therapy and

opioids have gastrointestinal side effects, with significant financial and health-

economic consequences.4 As drug therapy becomes less effective for pain

management, corticosteroid or hyaluronic acid injections are considerable

alternatives for immediate pain relief. However, people receiving repeated

injections may notice the period of pain relief minimizes over time with the

progressive degradation of cartilage.11 Physicians may recommend the surgical

intervention of a knee replacement for people with advance stages of knee OA.

Older adults are considered candidates for the orthopedic surgical procedure once

the integrity of the knee joint has been severely compromised causing functional

limitations and the impairment of pain is intolerable. However, patients may make

a personal choice to seek out conservative interventions in order to avoid surgery.

Several studies have advocated for the conservative management of

supervised physical therapy as an alternative to surgery to prevent or delay the

impact of disability associated with osteoarthritis.1,12-14 Physical therapy offers a

multimodal conservative approach consisting of therapeutic exercise, patient

education, shoe modifications, weight management, and thermal agents.

The previously mentioned interventions are commonly used in the field of

physical therapy as conservative treatments, though patient satisfaction is

3 3

infrequently achieved regarding pain management and improvement of function.

A physical therapy modality commonly used for treating knee OA symptoms is

hot pack application. Moist hot packs are cost effective and easily applied to

treatment in the outpatient physical therapy setting. Hot packs contain a clay

substance containing zinc oxide, talc, glycerol, activated carbon, and purified

distilled water in a nylon covering. The moist heating effect of hot packs have

been shown to offer instant and temporary relief for people suffering from knee

osteoarthritis.15

In an effort to advance the field of physical therapy there must be a shift in

the paradigm of conservative thermal treatments for knee osteoarthritis. Mud pack

therapy has been used in many European countries since the early 1800’s for the

treatment of musculoskeletal disorders branching from the intervention of

balneotherapy.15 Balneotherapy is the practice of immersing a subject in mineral

water or mineral infused mud and has traditionally been used in baths for the

treatment of osteoarthritis.15,16 Medical muds, known as peloids, have a high heat

storage capacity due to its volcanic sediment components providing long-lasting

heat by conduction with finely granulated organic and/or inorganic materials of

natural origin, minerals, and salts.16 The European League Against Rheumatism

(EULAR) has recommended mud pack therapy one of the non-pharmacological

interventions for joint dysfunction and pain management caused by knee

osteoarthritis.17

The Visual Analog Scale (VAS) is an assessment tool used to quantify and

objectively measure pain levels perceived by patients. The VAS uses a line

measured from 0-10 cm as 0 indicates no pain and 10 denotes the highest pain

possible perceived by a patient.18 The Western Ontario and McMaster Universities

(WOMAC) Osteoarthritis Index measures Pain (5 items), Stiffness (2 items), and

4 4

Physical Function (17 items). Five Likert responses, ranging from 0=none to

4=extreme, were available for each item.19 The Kellgren Lawrence (K-L) Scale is

an assessment tool used to determine the severity of an arthritic knee on a plain

radiograph. The grades range from 0 to 4, as grade 0 indicates no radiographic

features of osteoarthritis and 4 represents large osteophytes, marked joint space

narrowing, severe sclerosis, and definite bony deformity.19

The purpose of this meta-analysis is to bridge the gap in the literature as no

current meta-analysis exists comparing the efficacy of mud pack therapy versus

hot pack treatment in order to improve functionality and decrease pain in older

adults. The null hypothesis for this meta-analysis states mud pack therapy will

have no statistical significance compared to hot pack treatment. With the

application of mud pack therapy, it is hypothesized there will be a statistical

significance in favor of mud pack therapy to decrease pain intensity measured by

the VAS and decrease disability using the WOMAC for people suffering with

knee osteoarthritis.

METHODS

Search Strategy

The design of the meta-analysis used the Preferred Reporting Items for

Systematic Reviews and Meta-Analysis (PRISMA) as professional guidelines. An

electronic search began August 2016 and concluded September 2016. One

reviewer completed a computerized search using the following databases:

CINAHL, PubMed, and Science Direct. The search terms used to retrieve related

publications were: mudpack therapy, mud pack therapy AND knee osteoarthritis,

balneotherapy, balneotherapy AND knee osteoarthritis, mud compress, and

peloids. To specify the search for appropriate articles, filters were applied in each

database to locate available abstracts, full text, and peer-reviewed articles with

randomized control trials published in English from January 2010 to September

2016.

Selection Criteria

The inclusion criteria for this meta-analysis comprised of men and women

between the ages of 45-80 years old. Studies were included if the participants were

diagnosed with knee osteoarthritis with a grade of 1-4 using the Kellgren

Lawrence (K-L) scale, which categorizes the severity of OA.20 Studies with direct

comparison between mud-pack therapy and hot pack treatment were accepted with

outcome measures to evaluate pain levels using the Visual Analog Scale (VAS)

and improvements of function measured by the Western Ontario McMaster

Universities Arthritis Index (WOMAC).18,19 After reading the titles of the articles,

duplicate records were expelled from the search. Studies containing abstracts,

which did not relate to mud pack therapy and knee osteoarthritis were also

eliminated. Studies were excluded if subjects presented with a medical history of

6 6

surgery on the involved knee joint, subjects who received intra-articular injections,

or received physical therapy in the last 6 months. Studies with subjects presenting

with dermatological diseases or secondary inflammatory symptoms that are

contraindicated for receiving hot or mud pack application were also excluded.

Data Extraction

Data collected to assess pain level and function for subjects with knee

osteoarthritis were extracted from the tables within the results section of each

article. The experimental group received the application of mud pack therapy

while the control group was treated with hot packs. In order to conduct the

statistical analysis for the meta-analysis, the sample sizes, means, and standard

deviations for the experimental and the control groups were extracted from the

articles and inputted into the Metaanalyst 3.13 software. Tefner et al collected data

2.5 months post-treatment, Sarsan et al. and Gungen et al. collected data 3 months

following treatment, while Antunez et al. recorded results immediately after the

completion of the 11th treatment session.

Statistical Analysis

This meta-analysis has combined statistical data from the selected studies in

order to determine the grand effect size of the interventions, the confidence

interval, as well as the Q statistic and its associated p-value. The combined effect

size is quantifiable information gathered from a collection of studies used to

determine the effectiveness and how well an intervention will improves outcomes

compared to the control treatment. A small effect is indicated by an effect size less

than 0.3, a medium effect size ranges between 0.3 to 0.8, and an effect size above

0.8 represents the experimental intervention has a large effect to decrease pain and

improve function. The confidence interval, also known as the margin of error

7 7

determines statistical significance of the effect size if the zero y-axis is not

included within its range. Statistical significance indicates with 95% confidence an

intervention will have the determined effect size with the use of the experimental

intervention. The Q-statistic and its associated p-value establish the studies used in

the meta-analysis are homogeneous or heterogeneous. If the Q-statistic generated

is less than 2 degrees of freedom for this meta-analysis and the p-value is greater

than 0.05, the studies are considered to be conducted in a similar manner, reducing

variability and are noted as being homogeneous. Statistical data generating a Q-

statistic greater than 2 degrees of freedom and a p-value of less than 0.05 represent

the studies were designed with method inconsistencies and variability.

RESULTS

A search was completed through the computerized databases CINAHL,

PubMed, and Science Direct using the keywords: mud pack therapy, medical

peloids, and knee osteoarthritis. A total number of 869 articles were found with

the search terms, though only 37 abstracts were screened and considered

appropriate for the meta-analysis. Articles were excluded based on the titles,

which did not pertain to mud pack therapy nor published in English. From the

remaining abstracts, 21 full text articles were assessed for eligibility of the meta-

analysis. Sixteen articles were excluded from the meta-analysis if the desired

outcomes measures were not utilized, the publications were older than 5 years,

studies did not state age ranges for subject selection, or the means and standards

deviations were not provided in the studies. Once the search was finalized, 4

articles were acceptable, consisting of studies by Sarsan et al., Tefner et al.,

Antunez et al., and Gungen et al. Figure 1 displays a consort of all included and

excluded trials for the article search. Each study was appropriate for this meta-

analysis due to the subject population, outcome measures, study design, statistical

means, and standard deviations. All studies were selected as they fulfilled the

criteria for the established PICO.

The PEDro scale (see Appendix) was used to critically appraise the selected

articles for this meta-analysis in order to determine the quality of internal validity.

The 4 studies’ scores ranged from 5/10 to 8/10 with the common categories not

met: allocation concealment, blinding of subjects, blinding of therapists, blinding

of assessor, and intention to treat. In order to assess the strength and limitations of

each study, PEDro scores must be considered when reviewing statistical results.

The PEDro scores for the studies used in this meta-analysis are shown in Table 1.

9 9

Study Characteristics

Articles included in this meta-analysis were from Sarsan et al., Gungen et

al., Antunez et al., and Tefner et al. All the studies in the meta-analysis met the

standards set by the PICO criteria. These studies were appropriate to determine the

efficacy of mud pack therapy in the field of physical therapy based on the

population, study design, outcome measures, and the availability of means and

standard deviations.

The study by Sarsan et al.21 scored a 6/10 on the PEDro scale. The design

of the study compared the efficacy of mature mud pack and hot pack therapies on

patients with knee osteoarthritis that received a home exercise program for knee

active range of motion and isometric quadriceps strengthening. Outcome measures

recorded the subjects’ pain level and function 3 months post-treatment once 10

sessions were completed in 2 weeks. For this study, mud pack therapy did not

present with statistical significance, though a moderate effect size is noted to

reduce pain while only having minimal effect size to improve function. However,

mud pack therapy was favored compared to hot pack treatment to reduce pain and

increase function.

Gungen et al.22 scored a 5/10 on the PEDro scale. The study aimed to

evaluate the effectiveness of mud pack therapy to hot packs in a two-week

treatment. The outcome measures assessed pain intensity values and total physical

function scores 3 months after treatment. In regards to subjective pain response,

mud pack therapy had no statistical significance and a minimal effect size, which

was favored compared to the control group. Mud pack therapy was statistically

significant and was the favored intervention with a moderate effect size in order to

improve function 3 months after treatment.

10 10

Antunez et al.16 scored a 5/10 on the PEDro scale. The study analyzed the

effects of mud therapy application compared to a control group receiving drug

therapy after 11 consecutive sessions. After the intervention was provided on the

last session, statistical significance was noted, with a large effect size favoring the

intervention of mud therapy. In this study, a reduction of analgesic drug use was

observed in the experimental group compared to the control group after 11

treatments.

Tefner et al.24 received a score of 8/10 on the PEDro scale. The study

evaluated the effects of mud pack therapy compared to a control sham mud-pack

therapy on quality of life and function of patients with knee osteoarthritis. Subjects

were treated 5 consecutive days for 2 weeks. Data of the outcome measure

assessing the improvement of function and quality of life were collected 2.5

months after of the application of both thermal modalities. Although mud pack

therapy was favored as an alternative intervention for improving function among

older adults suffering with knee OA, this study was not statistically significant

with a minimal effect size.

Synthesis of Results

The Q-statistic value measuring perceived pain with the VAS in this meta-

analysis was 8.621, which is larger than the 2 degrees of freedom, while the p-

value was 0.013 determining the studies were heterogeneous. Mud pack therapy

has a least 95% confidence to provide moderate grand effect size (ES= -0.656)

when compared to hot pack treatment for the reduction of knee osteoarthritis pain.

The 3 studies used to determine the efficacy of mud pack therapy to decrease pain

have individual effect sizes ranging from a small to a medium effect size. Sarsan

et al. and Gungen et al. have confidence intervals that include the zero y-axis,

11 11

therefore are individually not statistically significant. Antunez et al is the noted

outlier with a medium effect size compared to the other studies. (Figure 2) As

previously reported, these studies are heterogeneous with variability in their

methods. Antunez et al. was the only study with a large sample size, though only

collected post-treatment data after the 11th visit. Subjects were allowed to use

analgesics throughout the trial, and the K-L grade levels were not reported for the

subjects diagnosed with knee OA.

The statistical analysis results for the WOMAC across the studies

determine the Q-statistic value of 1.464 and p-value of 0.481 signifying

homogeneity among the studies. The combined effect size (ES= -0.383), which

indicates mud pack therapy has a medium grand effect size on improving function

compared to hot pack treatment. The 3 studies used to analyze the effectiveness of

functional improvement using mud pack therapy determined individual effect

sizes ranging from a small to medium effect size as noted on the negative x-axis to

decrease disability on the WOMAC data analysis (Figure 2). The Metaanalyst

software reported Sarsan et al. and Tefner et al. are individually not statistically

significant, while the zero y-axis is not included in the confidence interval for the

study conducted by Gungen et al. As previously stated, homogeneity was

determined with minimal variability as all 3 studies had similar sample sizes,

using subjects within the same age range, collecting data 2.5 to 3 months post-

treatment, with comparable methods (Figure 2).

A decrease in pain level using the VAS and an improvement in function

with the WOMAC are represented by a negative effect size on the x-axis in the

forest plots (Figures 1 & 2). The confidence intervals for the grand effect sizes

analyzing pain and function outcome measures do not include the zero y-axis,

which indicates statistical significance. Mud pack therapy has statistical

12 12

significance with 95% confidence to decrease pain and improve functionality for

older adults suffering from knee osteoarthritis. Therefore, the alternative

hypothesis is accepted for this meta-analysis.

DISCUSSION

The purpose of this meta-analysis was to investigate the effectiveness of

mud pack therapy versus hot pack treatment in order to reduce pain and improve

functionality for older adults suffering with knee osteoarthritis. The meta-analysis

intended to bridge the gap in the literature as mud pack therapy is not currently

utilized in the field of physical therapy in the United States.17 It is important to

consider additional conservative treatments as surgical options are not readily

available for early stages of knee OA and patients in the later stages do not always

agree to a total knee arthoplasty.25 The degenerative joint disease has no effective

remedy and is considered the leading cause of pain and functional limitation

among older adults. 2,14-17 Therefore, introducing and investigating additional

interventions may improve the quality of life for the older adult population

affected by knee osteoarthritis.2

The data extracted from the selected articles for the VAS and WOMAC

outcome measures were inputted into the Metaanalyst 3.13 software in order to

generate collective statistical results. The meta-analysis indicates moderate grand

effectiveness for treating knee OA patients compared to the application of hot

pack treatment. The effects of mud pack therapy to relieve knee joint pain resulted

in a Q-statistic of 8.621, which is greater than the 2 degrees of freedom.

Heterogeneity was determined among the studies to investigate the reduction of

knee OA pain using of mud pack therapy. Therefore, a random-effect model was

applied to estimate the mean of distribution of the statistical data. While mud pack

therapy has not been extensively studied in the United States for the efficacy of

treating knee osteoarthritis; the analyzed data from this meta-analysis contains

meaningful findings as a viable physical therapy intervention. Mud pack therapy

14 14

has been reported to save approximately $730 (672 Euro) annually in healthcare

costs per patient, reducing medical visits, corticosteroid injections, and the

purchase of analgesics.26 The addition of mud pack therapy as a conservative,

topical thermal agent can be applied to the practice of physical therapy. It is easily

administered, increasing patient satisfaction, and optimizing compliance during

continued physical therapy treatment.

Although mud pack therapy has statistical significance in favor of

decreasing pain and improving function with a medium grand effect size, the

results must be interpreted with caution. It is necessary to address the limitations

causing variability among the selected studies as heterogeneity was previously

stated regarding the statistical analysis for pain management. One of the

limitations to recognize is the lack of studies used for this meta-analysis. Since

mud pack therapy has been studied in other countries outside of the United States,

it must be considered that quality studies were excluded from this meta-analysis

because they were not published in the English language.

Sample sizes for 3 out of the 4 studies used a small number of subjects

ranging between 15-26 participants for both the experimental and the control

groups. Antunez et al. was the only study in this meta-analysis with a considerably

large sample sizes selecting 61 subjects for the experimental group and 60 subjects

for the control group. The severity of knee osteoarthritis using the Kellgren-

Lawrence scale among the subjects varied due to the constraint in population

sizes. Tefner et al. accepted subjects with a K-L grade from 1 to 3, while Sarsan et

al. used subjects with a grade of 2 to 3 on the K-L scale. Gungen et al. conducted

the study using participants with advanced stages of K-L 3 to 4. Antunez et al.

stated the participants were diagnosed with osteoarthritis of the knee, but omitted

the stage of progression for the degenerative disease.21-24

15 15

Another limitation in the design across all 4 studies was the variation of

standardization for intervention parameters and protocols. In order to assess

internal validity, the selected randomized control trials were critically appraised

for their quality. The PEDro scores ranged between 5 to 8, from an average to

moderately high quality appraisal posing a threat to internal validity. The value of

the studies and threat to internal validity are also a factor in heterogeneity as the

analysis revealed a large difference between the upper and lower confidence

intervals. Since patients were not blinded in 3 out of the 4 studies, patients could

have possibly been biased when reporting self-perceived scores disrupting the

purpose of optimizing patient outcomes. Temperature and time duration of the

treatment application for both mud pack therapy and hot pack treatments varied

minimally between 30 to 45°C with a time duration from 20 to 30 minutes. Many

authors have studied the role and the mechanism of heat therapy as serum beta-

endorphin levels increase together as pain decreases, suggesting the role of

endogenous opoids.27-30 The lack of consistency to administer the experimental

and control interventions at a standard temperature and timeframe are factors

which may have resulted in heterogeneity among the studies.

Recommendations for the future direction on the effects of mud pack

therapy would need to be considered in order to implement this novel intervention

into the field of physical therapy. Objective functional outcome measures would

better quantify the improvements of physical function, increased distance, and

speed by using the 6-minute walk test and gait velocity. Currently, studies

attempting to record an improvement in functionality and quality of life utilize

surveys that are self-rated by the subjects. Although the Visual Analog Scale

quantifies pain, there is an absence of a gold standard as subjects perceive pain

differently, thus criterion validity cannot be evaluated appropriately.18 Antunez et

16 16

al. and Tefner et al. noted a decrease of NSAIDS and drug use such as

paracetamol for pain management. The experimental group receiving mud pack

therapy showed a continuous downward trend at the subsequent post-treatment

visit and were significant by the last visit compared to baseline.23,24 Therefore,

future studies should log the intake of analgesics from base line to post treatment

to objectively measure an improvement in pain management. Contrary to the

studies conducted by Antunez et al. and Tefner et al., the effect sizes for the VAS

and WOMAC in the study by Gungen et al. were the outliers in the data analysis.

The small effect size for perceived pain (ES= -0.125) has no correlation to the

moderate improvement in function (ES= -0.695) the subjects gained with the

application of mud pack therapy. Studies should also focus on noting the quantity

of biochemical markers at the cellular level. Bellometti et al. reported mud pack

treatments decrease chemical biomarkers serum levels affect the integrity of the

knee articulation.30,31 Therefore, data collected 6 to 12 months after treatment will

help determine if mud pack therapy would have a carry-over effect to delay the

onset of inflammation, pain, and cartilage degradation caused by interlukin-6,

tumor necrosis factor-alpha, and YKL-40.22,27-29,31

CONCLUSION

This meta-analysis determined the use of mud pack therapy to be

statistically significant to reduce pain and improve functionality for people

suffering with knee osteoarthritis. The medium grand effect size reported from the

statistical analysis demonstrates mud pack therapy would optimize patient

outcomes. However, due to the novelty of the intervention in the United States, it

is important to recognize more studies are needed with larger sample sizes,

improved methodological processes, and longer follow-up periods. In order to

mitigate the affects of knee OA, it is important to continue evaluating the clinical

efficacy of mud pack therapy as a conservative treatment to advance the field of

physical therapy.

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TABLES

23 23

Table 1. Study Characteristics

Criterion

Meta-Analysis Studies

Antunez et

al.

Gungen et

al.

Sarsan et

al.

Tefner et

al.

1. Random Allocation of

subjects

X

X

X

X

2. Allocation concealed

3. Similar groups at

baseline

X

X

X

X

4. Subjects blinded

X

5. Therapists

administering treatment

blinded

6. Assessors blinded

X

X

7. One key outcome

obtained from 85% of

subjects

X

X

X

X

8. Data of one key

outcome was analyzed by

“intention to treat”

X

9. Between-group

statistics for one key

outcome reported

X

X

X

X

10. Point measure and

measure of variability

for one key outcome

X

X

X

X

Total Score 5 5 6 8

FIGURES

25 25

Figure 1. Data analysis-pain

Figure 2. Data-analysis-function

APPENDIX: PEDRO SCALE

27 27

28 28