COMBINED MULTIMODAL THERAPIES FOR CHRONIC TENNIS ELBOW: PILOT STUDY TO TEST PROTOCOLS FOR A RANDOMIZED CLINICAL TRIAL Mohsen Radpasand, DC, MD, MCR,a and Edward Owens, MS, DCb ABSTRACT Objective: The objective of this project was to develop and test protocols for a randomized clinical trial (RCT) of 2 multimodal package therapies for chronic lateral epicondylitis. Methods: Six participants were enrolled after case review and randomized to 1 of 2 groups (4 in group A and 2 in group B). Group A had high-velocity low-amplitude manipulation, high-voltage pulse galvanic stimulation, counterforce bracing, ice, and exercises, whereas group B had ultrasound, counterforce bracing, and exercise. Both groups had 12 weeks of active care and instructed to restrict usage of the affected elbow. Participants filled out a visual analog scale and the Patient Rated Tennis Elbow Evaluation every week. The pain-free grip strength test was measured at baseline, and at the end of the third, sixth, ninth, and twelfth visits. Results: One participant in group A dropped out before the end of care. Both groups demonstrated changes in all of the outcome variables from the baseline to the end point (12 weeks) of treatment. Sample size for a larger future randomized clinical trial was calculated as n = 246 participants. Conclusion: The pilot study demonstrated that the study design is feasible and that patients could be recruited for a 12-week trial of multimodal treatment. A larger trial is warranted in a multicenter setting to detect differences in the effects of these treatment strategies. (J Manipulative Physiol Ther 2009;32:571-585) Key Indexing Terms: Braces; Chiropractic; Cryotherapy; Electric Stimulation Therapy; Lateral Humeral Epicondylitis; Musculoskeletal Manipulations; Rehabilitation Lateral epicondylitis, also known as tennis elbow, is defined as pain over the lateral aspect of the elbow1 that is aggravated by active wrist extension and direct palpation over the lateral epicondyle of the humerus, the radiohumeral joint space, or the proximal muscle bellies.2-5 It is the most common tendinitis and overuse injury of the elbow.6-9 There have been reports dating from 1882 to the present about the etiology, diagnosis, and treatment of lateral epicondylitis with no conclusive results or agreement about management.10 The incidence of lateral epicondylitis is approximately 1% to 3%, with less than half of patients seeking medical care 11-15; the prevalence has been reported to be between
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COMBINED MULTIMODAL THERAPIES FOR CHRONIC
TENNIS
ELBOW: PILOT STUDY TO TEST PROTOCOLS FOR A
RANDOMIZED CLINICAL TRIAL Mohsen Radpasand, DC, MD, MCR,a and Edward Owens, MS, DCb
ABSTRACT
Objective: The objective of this project was to develop and test protocols for a randomized clinical
trial (RCT) of
2 multimodal package therapies for chronic lateral epicondylitis.
Methods: Six participants were enrolled after case review and randomized to 1 of 2 groups (4 in
group A and 2 in group
B). Group A had high-velocity low-amplitude manipulation, high-voltage pulse galvanic stimulation,
counterforce
bracing, ice, and exercises, whereas group B had ultrasound, counterforce bracing, and exercise. Both
groups had
12 weeks of active care and instructed to restrict usage of the affected elbow. Participants filled out a
visual analog scale
and the Patient Rated Tennis Elbow Evaluation every week. The pain-free grip strength test was
measured at baseline,
and at the end of the third, sixth, ninth, and twelfth visits.
Results: One participant in group A dropped out before the end of care. Both groups demonstrated
changes in all of the
outcome variables from the baseline to the end point (12 weeks) of treatment. Sample size for a larger
future randomized
clinical trial was calculated as n = 246 participants.
Conclusion: The pilot study demonstrated that the study design is feasible and that patients could be
recruited for
a 12-week trial of multimodal treatment. A larger trial is warranted in a multicenter setting to detect
differences in
the effects of these treatment strategies. (J Manipulative Physiol Ther 2009;32:571-585)
Key Indexing Terms: Braces; Chiropractic; Cryotherapy; Electric Stimulation Therapy; Lateral
. Table 2. Baseline characteristics of participants' job description Variables
Frequency n = 5
Group A Group B Overall
Working posture: arm lifted in front of body
1/4 to 1/2 of time 2 0 2
3/4 to almost all the time 1 2 3
Working posture: hands bended or twisted
1/4 to 1/2 of time 2 1 3
3/4 to almost all the time 0 1 2
Repetitive movements: movement of fingers or hands
1/4 to 1/2 of time 2 0 2
3/4 to almost all the time 1 2 3
Repetitive movements: some movement of arms
1/4 to 1/2 of time 2 2 4
3/4 to almost all the time 1 0 1
Work activity demands
Light repetitive 2 1 3
Heavy intermediate 0 1 1
Heavy repetitive 1 0 1
The multimodal group B had elbow pain for a longer
duration, lower PFGS score at the baseline, and slightly
higher PRTEE on all levels compared with multimodal
group A. Both multimodal package groups demonstrate
changes in all of the outcome variables from the baseline
to the end point (12 weeks) of treatment (Figs 6-8). For
the multimodal package group A, there was a 59% change
for PRTEE total, 3.2% change for PFGS, and 51.4%
VAS_24hs worst pain felt compared to 9.5%, 169.0%, and
65.1%, respectively, for the multimodal package group B
(Tables 3 and 4). The painful elbow showed less strength
than the nonpainful one, and it is noticeable that there is
an inverse relationship between PRTEE and PFGS, as we
would expect.
With the use of PFGS to estimate sample size, n = 69 in
each 2 groups and with the use of PRTEE total, n = 123 in
each 2 groups. Therefore, it is recommended that at least 123
participants (some more would be ideal considering the
potential loss to follow-up) be recruited for each 2 groups in
a future study to achieve a power of .80; that is, a real
significant difference in terms of PFGS and PRTEE between
the 2 groups/treatments.
DISCUSSION
Our purpose was to develop and test protocols for a
randomized clinical trial (RCT) of combined multimodal
therapies for CLE (a 12-week multimodal conservative
management in a specific sequence) and to estimate the
effect size and variability for future larger clinical studies.
Our recruitment may have been skewed toward producing
white-collar participants. We used free methods of recruitment
including advertisements in a free weekly newspaper
that were distributed in professional/technical communities.
In future trial we will need to allocate funds for advertising to
increase the recruitment rate, in addition to directing our Table 2. Baseline characteristics of participants' job description Variables
Frequency n = 5
Group A Group B Overall
Working posture: arm lifted in front of body
1/4 to 1/2 of time 2 0 2
3/4 to almost all the time 1 2 3
Working posture: hands bended or twisted
1/4 to 1/2 of time 2 1 3
3/4 to almost all the time 0 1 2
Repetitive movements: movement of fingers or hands
1/4 to 1/2 of time 2 0 2
3/4 to almost all the time 1 2 3
Repetitive movements: some movement of arms
1/4 to 1/2 of time 2 2 4
3/4 to almost all the time 1 0 1
Work activity demands
Light repetitive 2 1 3
Heavy intermediate 0 1 1
Heavy repetitive 1 0 1
Fig 6. Pain-free grip strength change.
Fig 7. Patient-Rated Tennis Elbow Evaluation total change.
Fig 8. Visual analog scale change (2 Table 3. Outcome variables for multimodal group A Variables Mean (SD) Change from baseline to end point % Change
VAS_24hs_least at baseline 9.0 (4.3)
VAS_24hs_least at end point 7.5 (5.0) −1.5 a 16.7
VAS_24hs_worst at baseline 34.0 (25.5)
VAS_24hs_worst at end point 21.5 (16.3) −17.5 a 51.4
PRTEE pain component at baseline 19.0 (8.5)
PRTEE pain component at end point 8.0 (2.9) −11.a 58.0
PRTEE special activity component at baseline 22.5 (17.7)
PRTEE special activity component at end point 6.5 (2.1) −16.a 71.1
PRTEE usual activity component at baseline 11.0 (5.7)
PRTEE usual activity component at end point 7.0 (2.8) −4.a 36.3
PRTEE total at baseline 35.8 (20.1)
PRTEE total at end point 14.8 (5.3) −21.a 59.0
PFGS at baseline 56.2 (18.0)
PFGS at end point 58.0 (34.4) +1.8 b 3.2
a Negative: improved.
b Positive: increased function—improved. 4 hours) worst pain
recruitment strategy toward attracting blue-collar industry
participants. Our possible success in having few drop-outs
was that we explained the complex 12-week (3 months)
treatment schedule up front before the start-up, negotiated
the time schedule, and gave them a copy of their 3-month
schedule. In addition, we explained the pathogenesis of
tendinosis and rationale behind the prolonged treatment
schedule. We think pretesting the forms was a success
because we had minimal missing data. Even with the small
sample size of our participants, our findings were similar to
other studies' finding2-4,14,122 with regard to age, duration of
elbow pain, involvement of the dominant elbow, association
with repetitive movements of the hands or wrist, and the
occurrence of right-sided epicondylitis twice more frequently
than left-sided epicondylitis.
We did see a difference in PFGSs at baseline between the
groups. The painful elbow showed less strength than the
nonpainful one, as expected. Some studies had found
association with decreased grip strength and lateral
epicondylitis.123,124 Therefore, improvement in grip strength
measurement could reflect good treatment outcomes.125 In
addition, the PRTEE scores within the groups correlate with
the severity of the elbow pain: as PFGS decreases, PRTEE
increases. This inverse relationship was also apparent at the
end point because as PRTEE decreased the PFGS increased.
Participants' compliance with the treatment and study
protocols appear to be high because there was no
expression of dissatisfaction on being in either of the
groups. Participants adhered well to treatment schedule
because there was only one dropout. Although we
distributed an exercise booklet and explained all the
exercises properly, we did not use a diary for the
reinforcement of either the exercises or the ice protocols.
We realize that this may be a shortcoming on our part.
However, at each treatment visit, the examiner asked about
either exercise or the ice, and whether there had been any
problem following through. In our future study, we will
explore the use of registered diary for measuring participant
compliances. In addition, although the 12-week treatment
duration is the usual treatment protocol for chronic tennis
elbow, there is a need for at least a 6-month follow-up to
see if changes that occurred were sustainable overtime
because a 54% chance of recurrences has been reported in
―cured ‖ patients within 6 months.126 However, because of
time limitations, we were unable to do this. In addition, we
could not justify having a placebo group because of the
lengthy treatment schedule. These issues will be addressed
in a larger-scale study.
Although this pilot study was not designed to address the
effectiveness of the counterforce bracing, we wish to explain
the rationale behind the counterforce bracing placement
position. Cumulative overuse or misuse may cause displacement
or avulsion at the muscle origin, as in Osgood
Schlatter's, and consequently could result in a decrease in
microcirculation and anaerobic metabolism in the extensors.
Tearing of muscle fibers has been seen at the musculotendinous
interface.127 The mechanism of injury is due to the
excessive eccentric muscular interaction that leads to
considerable ultrastructural changes to skeletal muscle,
which is an injury-delayed onset of muscle soreness.128
Placing the hard knob padded counterforce brace on the
origin site, or at the lateral epicondyle area, is intended to
keep the muscle origin in its place, and when the ECRB
contracts, the brace would stop the muscle from pulling away Table 3. Outcome variables for multimodal group A Variables Mean (SD) Change from baseline to end point % Change
VAS_24hs_least at baseline 9.0 (4.3)
VAS_24hs_least at end point 7.5 (5.0) −1.5 a 16.7
VAS_24hs_worst at baseline 34.0 (25.5)
VAS_24hs_worst at end point 21.5 (16.3) −17.5 a 51.4
PRTEE pain component at baseline 19.0 (8.5)
PRTEE pain component at end point 8.0 (2.9) −11.a 58.0
PRTEE special activity component at baseline 22.5 (17.7)
PRTEE special activity component at end point 6.5 (2.1) −16.a 71.1
PRTEE usual activity component at baseline 11.0 (5.7)
PRTEE usual activity component at end point 7.0 (2.8) −4.a 36.3
PRTEE total at baseline 35.8 (20.1)
PRTEE total at end point 14.8 (5.3) −21.a 59.0
PFGS at baseline 56.2 (18.0)
PFGS at end point 58.0 (34.4) +1.8 b 3.2
a Negative: improved.
b Positive: increased function—improved. from its attachment. If the relief of tensile stress on the
attachment helps to decrease pain, it may, at the same time,
promote formation of tissue regeneration by increasing the
microcirculation in the area. As Fess and McCollum129
indicated, immobilization allows healing and splinting has a
positive influence on collagen remodeling through application
of low-load forces. They go on to emphasize that no
other currently available modality is able to hold a constant
low-load tension for a prolonged time sufficient to cause
tissue growth.
In contrast, the placement of the counterforce brace in a
customary place (in line with the lateral epicondyle, over the
proximal one third of forearm)18,20 would dampen the
already weakened muscle activity and create more disability.
As Walther et al93 has found, bracing with padding on the
forearm provides the highest reduction of acceleration
amplitude, and acceleration integrals as compared to padding
on the lateral epicondyle.
The exercises used in this protocol, in addition to their
gradual sequential format and end point of contraction,
encompass most elbow activities including supination,
pronation, elbow/wrist extension-flexion, and ulnar/radial
deviation. These exercises put the ECRB and extensor carpi
radialis longus under the maximal muscle strain.130 Placing
these muscles under the maximal strain after a period of pain
reduction and collagen remodeling has the greatest biomechanical
effect on increasing functions. One must indicate
that these exercises must be performed in a continuous nature
for a minimum of 6 months after the end of treatment to see
the maximal effectiveness. In addition, our study supports
apparent idea of combined effect of exercise and ultrasound
in the pain reduction.28,113,115
In regard to the sample size, we at least need 123
participants per group to encompass the PFGS calculation.
Therefore, for our future larger RCT, we will need a
minimum of n = 246 participants, and we will try to launch a
multicentric clinical trial.
CONCLUSION
Pretesting the forms before the study began was valuable
because it resulted in refinement of items and the
participants' instructions, which in turn minimized missing
data. It appears the study protocol and forms used in this
study are sufficient and effective, allowing us to capture the
required information and would subsequently support a
larger RCT.
This study is feasible because we were able to recruit
chronic participants. The recruitment rate in our center was
approximately 1 participant per 10 days with minimal effort,
or expenses in the participant recruitment procedure, and
there were minimal missed visits. In addition, both
multimodal packages appear to reduce pain and increase
functional ability. Therefore, further investigation of these
treatment packages seems feasible and warranted.
Although RCTs comparing different treatment strategies
for lateral epicondylitis have previously been done, to our
knowledge, none of the previous studies tried to incorporate
the HVLA manipulation within the combination
package of treatment in one of the treatment groups and
used this combination of outcome measurements, as well as
using the placement of the counterforce brace, as we have
done in this study. Our treatment protocol was toward Table 4. Outcome variables for multimodal group B Variables Mean (SD) Change from baseline to end point % Change
VAS_24hs_least at baseline 23.0 (9.9)
VAS_24hs_least at end point 10.5 (10.7) −12.5 a 54.3
VAS_24hs_worst at baseline 56.0 (5.7)
VAS_24hs_worst at end point 19.5 (22.0) −36.5 a 65.1
PRTEE pain component at baseline 17.0 (2.9)
PRTEE pain component at end point 7.5 (5.0) −9.5 a 56.0
PRTEE special activity component at baseline 12.0 (4.2)
PRTEE special activity component at end point 6.5 (0.8) −5.5 a 46.0
PRTEE usual activity component at baseline 11.0 (1.4)
PRTEE usual activity component at end point 6.5 (0.7) −4.5 a 41.0
PRTEE total at end point 28.5 (1.4)
PRTEE total at end point 14.2 (28.1) −2.7 a 9.5
PFGS at baseline 16.0 (16.0)
PFGS at end point 43.5 (41.7) +27.b 169.0
a Negative: improved.
b Positive: increased function—improved. breaking down tendinosis cycle rather than inflammation.
Therefore, to break down the tendinosis cycle and to
produce new collagen, we used rest, modalities, and HVLA
mobilization. We also tried to address the pain as well as
the functional components of this condition in our
multimodal packages of treatment of CLE. In addition,
our exercise protocols cover most elbow activities including