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Combined Multimodal Therapies for Chronic Tennis Elbow: Pilot Study to Test
Protocols for a Randomized Clinical Trial

Article  in  Journal of manipulative and physiological therapeutics · September 2009


DOI: 10.1016/j.jmpt.2009.08.010 · Source: PubMed

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Mohsen Radpasand Edward F Owens


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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 Humeral
Epicondylitis; Musculoskeletal Manipulations; Rehabilitation

ateral epicondylitis, also known as tennis elbow, is The incidence of lateral epicondylitis is approximately

L 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
1% to 3%, with less than half of patients seeking medical
care 11-15; the prevalence has been reported to be between
1% and 10%, depending on the age group investigated.11
radiohumeral joint space, or the proximal muscle bellies.2-5 Women are more often affected than men, with a peak
It is the most common tendinitis and overuse injury of the prevalence at age 42 to 44 (range, 30-50 years) of 9% and
elbow.6-9 There have been reports dating from 1882 to the 3%, respectively.11,14,16-18 These differences may be due to
present about the etiology, diagnosis, and treatment of factors related to employment, psychological-physiological,
lateral epicondylitis with no conclusive results or agreement cultural, and biological factors.17,19 The dominant arm is
about management.10 involved twice as often as the nondominant arm.20 Most
(80%) of the injuries represent chronic, repetitive ones that
tend to be related to a particular profession or a particular
a
Private practice, Shipman Chiropractic Clinic, Davenport, Iowa hobby, whereas the remaining (20%) are related to direct or
52807. indirect acute injuries.20
b
Director, Office of Data Management Wolf-Harris Center for In the United States, work-related disorders of the upper
Clinical Studies Northwestern Health Sciences University, Bloo- extremities account for more than 50% of all occupational
mington, Minn 55431.
Submit requests for reprints to: Mohsen Radpasand, DC, MD, illnesses.21 In particular, in female workers, the claims for
MCR, Shipman Chiropractic Clinic, 1850 East 53rd; Suite 2, epicondylitis have increased by 125% from 1988 to 1995.
Davenport, Iowa 52807, USA Despite the epidemic, a comprehensive treatment of
(e-mails: [email protected] [email protected]). epicondylitis has not been well established.22,23 More than
Paper submitted February 20, 2009; in revised form May 23, 40 different treatments used separately or in combination
2009; accepted June 8, 2009.
0161-4754/$36.00 aiming to reduce pain and increase function have been
Copyright © 2009 by National University of Health Sciences. described.24-27 With all the clinical heterogeneity and overall
doi:10.1016/j.jmpt.2009.08.010 inconclusive finding of the reviews, there are a few valid

571
572 Radpasand and Owens Journal of Manipulative and Physiological Therapeutics
Chronic Tennis Elbow September 2009

studies that suggest potential effectiveness of treatment28; for grammar and material contents. The college institutional
however, the optimal treatment remains undefined.26 review board approved the study protocol and all the forms.
The pathophysiology of this condition is not well During the first baseline visits, we had participants sign
understood. However, it has been suggested that the factors the first consent form and fill out the demographic form
leading to lateral epicondylitis are more cumulative in nature and clinician questionnaire. After having their eligibility
rather than from occasional trauma.29,30 It is known that confirmed during case review sessions, at the second
repetitive and sustained contraction of the extensor carpi baseline visit, we had them sign the second consent form,
radialis brevis (ECRB) and extensor digitorum communis and we conducted the clinical examination and obtained
muscles contribute to the signs and symptoms associated baseline measures. Each participant was then allocated
with this condition.1,7,31-34 This overuse tendinopathy is randomly to one of the package groups and received their
tendinosis or collagen degeneration rather than tendinitis or first treatment. The sequence of the assignment was a
inflammation in nature.35,36 There are 2 nontraumatic predetermined randomization scheme (using a random
biomechanical theories for the pathogenesis of lateral number table) in a 1:1 allocation ratio. All participants
epicondylitis.37 The first one is tensile loading, which were randomized by the use of sealed, opaque, sequentially
postulates that tearing of the extensor muscle tendons arising numbered envelopes. At each visit, all the participants were
from eccentric movements exceeds an endurable rate of requested to fill out the VAS_24hs questionnaire, and every
strain of the tendons fibers.7,34 This theory supports the week the participant also filled out the PRTEE. The PFGS
repetition aspect of the cause rather than duration. The test was measured at the baseline and at the end of third,
second one is radial head compression, which postulates the sixth, ninth, and twelfth visits (Fig 1). All the data were
creation of compression between the radial head, annular collected by the study coordinator and then transferred in
ligament, and ECRB aponeurosis due to the tensile loading an opaque envelope to the data manager. The clinician was
of extensor muscles in combination with elbow extension, blinded to the data, and the participants were instructed not
pronation, and supination.38,39 to discuss anything related to the data collection procedures
This pilot study describes the development and testing of with their clinician.
protocols for a simple systematic multimodal package of
treatment consisting of 12 weeks of conservative manage-
Study Population
ment in a specific sequence for chronic lateral epicondylitis
Participants from the Quad City metropolitan area (a
(CLE) using a high-velocity low-amplitude manipulation
population of 300 000 people) with CLE were recruited
(HVLA), high-voltage pulse galvanic stimulation
from May 5 to June 25, 2008, using fliers and free
(HVPGS), counterforce brace, ice, and exercises for group
weekly newspaper ads. The ads were distributed in
A, and ultrasound, counterforce brace, and exercise for
professional/technical communities. CLE refers to the
group B. Both groups had instructions to restrict usage of
condition with the duration of pain of at least 6 months.
the affected elbow.
The participants were enrolled provided they met the
diagnostic conditions, in addition to the inclusion and
exclusion criteria described below.
METHODS
Overview of Research Design Diagnosis of Lateral Epicondylitis
We developed this pilot study to test forms and Participants with pain for a duration of at least 6 months,
procedures to be used in a future trial and to test the success and with pain over the lateral epicondyle evoked by 2 or
of recruitment strategies, screening procedures, and feasibil- more of the following 4 tests, were included in the studies:
ity of the 12-week proposed treatment plan. We designed (1) pain evoked by palpation of lateral epicondyle8; (2)
several forms and modified others to suit our study. The resisted wrist extension (position: shoulder flexion 60°,
designed forms were the physical examination, pain-free grip nonsupported elbow extension; forearm pronated; wrist
strength (PFGS), visual analog scale (VAS_24hs), baseline extended about 30°; pressure applied to the dorsum of the
consent form for visit 1, baseline consent form for visit 2, second and third metacarpal bones in the direction of flexion
and a clinician questionnaire. The modified forms consisted toward the ulnar side to prove involvement of the ECRB and
of the verbal instruction for the PFGS, the Patient-Rated longus); (3) resisted finger extension (position: 60° of
Tennis Elbow Evaluation (PRTEE), a telephone screening shoulder flexion, elbow extended, forearm pronated, and
form, and patient withdrawal form. All forms were read for finger extended; resisted extension was applied manually on
grammar and material content by the acting director of the digits II to V to prove involvement of the extensor indicis,
research clinic, a fellow at the research center, the study the extensor digitorum, and the extensor digiti minimi;
coordinator, and other research center staff, and were resistance applied on digitus III was the middle-finger test);
pretested on a few patients. A research center faculty and (4) pain in the region of the lateral epicondyle during
member who is an expert in bioethics read the consent forms resisted extension of the middle finger (Maudsley's test),
Journal of Manipulative and Physiological Therapeutics Radpasand and Owens 573
Volume 32, Number 7 Chronic Tennis Elbow

Fig 1. Overview of the study design.


574 Radpasand and Owens Journal of Manipulative and Physiological Therapeutics
Chronic Tennis Elbow September 2009

considered to be a sensitive test indicating that at least a not perform, an activity listed please ESTIMATE the pain or
portion of the extensor is involved.40-42 difficulty you would expect if you performed that activity.”
We think the addition of this sentence reduced data reduction
procedures and saved the study coordinator's time and effort
Inclusion Criteria in data cleaning.
Inclusion criteria include history of epicondylalgia of the Pain-Free Grip Strength __ Gripping to the Point Of Pain. Pain-free
radial humerus, lateral epicondyle pain at rest and during grip strength was measured with a Jamar Digital Hand
resisted dorsiflexion of the wrist with elbow in full extension, Dynamometer (serial no. 41100114; Therapeutic Equipment
pain for at least 6 months, ability to read and verbally Corporation, Clifton, NJ) set at the second handle
comprehend English, and age between 21 and 65 years. position.49-53 The reliability, and validity, of the handheld
dynamometer has been stressed and has been found to be
the standard of objective strength measurements.49,54 Men
Exclusion Criteria
demonstrate greater grip strength than women at any age55-58
Exclusion criteria include treatment by a health care
and grip strength diminishes curvilinearly with age.
practitioner within the proceeding 6 months for lateral There are few functional differences between the mean
epicondylitis, injections of corticosteroid at involved site
scores of right hand–dominant and left hand–dominant
during the preceding 6 months, bilateral elbow symptoms,
subjects.57 Injured hands are weaker than healthy hands.59,60
wrist or hand pathology, signs and symptoms suggesting a The standardized instrumentation, normative data, and
cause other than overuse (eg, cervical radiculopathy), information on test repeatability are available for measures
congenital or acquired elbow deformity, surgery or disloca- of hand grip.57,61-64 In addition, there are also correlations
tion of the elbow, tendon ruptures or fractures in the elbow with stature and weight.65 In our study, we used PFGS
area in the preceding 12 months, known systemic disorders because PFGS is more sensitive to change than maximum
of the musculoskeletal system (eg, myasthenia gravis, grip strength.66 Furthermore, maximum grip strength is least
osteoporosis, hemophilia, fibromyalgia, rheumatoid arthri- valid in demonstrating change.67
tis), neurologic disorders (central or peripheral nervous In addition, we used the written instruction of Haward
system diseases), immobility cast on either elbow or hand of et al58 read by the examiner. To capture the pain threshold
the involved side, pregnancy, pacemaker, or previous over time, we modified the instruction read by the examiner
experience with manipulative therapy to the elbow joint. as such: “The purpose of this is to test your pain-free
maximum hand grip strength. You will be asked to repeat
Selection Criteria for Provider this three times with each side beginning with your right (or
The provider was a chiropractor with a minimum of 10 left if appropriate) side. Please hold the grip strength meter in
years in practice and a track record in treating upper- a comfortable position and when you are ready squeeze the
extremity abnormalities, especially this type of complaint. handle as hard as you are able, to the point where your pain
starts. After one maximum squeeze, relax your hand and I
will take the meter from you and record the measurement.”
Outcome Measures The examiner waited 30 seconds between each measure-
Patient-Rated Tennis Elbow Evaluation. The PRTEE was initially ment. We incorporated the recommendations of Mathiowetz
developed in 1998.43 PRTEE is a simple, reliable,44,45 et al57 and the American Society of Hand Therapists'
valid46 assessment tool that was designed specifically for suggestion of standardized arm position for strength
patients with lateral epicondylitis.44,47 The reliability of tests.63,68 The mean values of the 3 grip strength attempts
PRTEE in patients with lateral epicondylitis has been were calculated.49 The grip strength started with the pain-
established for both the pain (intraclass correlation coeffi- free hand first. In addition to grip strength in kilograms, we
cient [ICC], 0.89) and function (ICC, 0.83) subscales and also collected data on age (years), weight (kilograms), height
also for the overall score (ICC, 0.89) by the developers of the (centimeters), dominant hand, and occupation. Calibration of
questionnaire44 and in other studies (ICC: pain, 0.96; the dynamometer was checked regularly, and the same test
function, 0.92; total, 0.96).47 The overall PRTEE and the instrument was used throughout the study.
pain and function subscales of the PRTEE were analyzed. Visual Analog Scale. We used a100-mm VAS to assess pain in
The function subscale was further broken down into specific the past 24 hours. VAS is a valid and reliable measure of
activity and usual activity.48 chronic and acute pain. 69-73 We designed this form
A common finding with PRTEE is that patients will not ourselves. We took 2 of the questions from PRTEE's pain
know how to answer questions related to movements they components and asked the participants to scale them on VAS
rarely perform. This can result in missing data. We followed pain scales to let us know what their pain was during the past
MacDiarmid's48 suggestion and encouraged participants to 24 hours.
estimate their average difficulty of any task that is rarely The 11-point numeric rating scale (NRS-11) and a 100-
performed. We added this sentence to the form: “If you did mm VAS has similar sensitivity; therefore, choices between
Journal of Manipulative and Physiological Therapeutics Radpasand and Owens 575
Volume 32, Number 7 Chronic Tennis Elbow

the VAS and NRS-11 can be based on subjective has been demonstrated.85 The effectiveness of manipulation
preferences.74 On average, a reduction of approximately 2 may be due to the changes in biomechanical, anatomical, and
points or a reduction of approximately 30% in the NRS nerve relationships that result in unique hypoalgesia
represents a clinically important difference.75 A mean effect,86,87 in addition to the possible effect on breaking
reduction in VAS of 30.0 mm represents a clinically down adhesions for a chronic lesion. This HVLA manip-
important difference in pain severity that corresponds to ulative thrust has been reported previously.88
patients' perception of adequate pain control. Defining
minimal clinical important differences based on adequate Exercises. Exercises consisted of (1) forearm supinator
analgesic control rather than minimal detectable change may and pronator muscles performed with an imbalanced
be more appropriate for future analgesic trials when effective adjustable dumbbell weight, (2) forearm extensor and
treatments for acute pain exist.76 flexor muscle exercises using a free standing dumbbell,
(3) forearm supinator and pronator muscle exercises using
an imbalanced adjustable dumbbell weigh (a hammer), and
Treatment Procedures (4) putty therapeutic exercise. All were performed with
Multimodal Group A isometric contraction at the end range of motion. The goal
was to maintain contractions for 10 seconds, with 10
Overview. Participants were seen 3 times per week for 4 repetitions maximum, twice a day. The goal for all the
weeks, then 2 times per week for 3 weeks, and then once per exercise protocols 1, 2, and 3 were to have the participants
week for 4 weeks. At each visit, participants received HVLA maintain the duration of 10 seconds, with 10 repetitions
treatment at the involved elbow. Then, the involved elbow maximum. In case the participants could not perform that
was placed under the HVPGS with the positive pad placed many repetitions, the clinician instructed the participants to
over the lateral epicondyle and the negative pad placed at the start with the 5 repetitions and to increase by one repetition
base of the scapula on the involved side while lying down each day up to 10 repetitions maximum. The progressions
supine for 10 minutes. Stimulation was delivered to the in load imposed on the muscle could be achieved by
participant's tolerance. Participants were instructed how to increasing the number of repetitions starting from 5 to 10,
place the knob of a hard padded elbow counterforce brace according to the participants' tolerance. These procedures
directly on the most painful point over the lateral epicondyle have been detailed previously.88
rather than on the muscle belly. Exercise protocols were For the forearm extensor muscle exercise with isometric
given at the start of week 6. Each participant was instructed contraction at the end of range, the participant sits in a chair
to remove the brace while performing the exercises and with the upper body in sound postural alignment.81 The
reapply it after the exercises. At the end of week 7, forearm was fully stabilized and the edge of a table was
participants were seen once a week, and the putty therapeutic placed 3 to 6 cm away from the wrist joint. Using a free-
exercise was added. At the end of week 8, participants could standing dumbbell (approximate weight, 500 g), this exercise
remove the brace while at home and wear it while doing had 2 positions, being pure extension at the wrist and then
daily activities. They resumed light daily activities with the radial deviation and extension. At the end of the position, the
involved hand and had the brace off completely at the end of participants squeezed the dumbbell weight as tightly as
week 10. Ice was applied when needed for pain or soreness. possible while holding it for 10 seconds then waited for a few
At the end of week 12, participants received final treatment, seconds and repeated this 10 times maximum.
and all outcome measurements were assessed. For the forearm flexor muscle exercise with isometric
contraction at the end range, the participants sat in a chair
Manipulation. Manipulation was delivered as a HVLA with the upper body in sound postural alignment.81 The
thrust, using the pad of the thumb in a posterior to anterior forearm was fully stabilized and the edge of a table was
direction over the posterior aspect of the radial head, placed 3 to 6 cm away from the wrist joint. Using a free-
approximately on top of the attachment of the extensor standing dumbbell (approximate weight, 500 g), this
tendon to the lateral epicondyle. Participants sat in a chair exercise had 2 positions, pure flexion at the wrist and then
with the upper body erect leaning against the chair's back. radial deviation and flexion. At the end of the position, the
The clinician's opposite hand held the dorsum of the participants squeezed the dumbbell weight as tightly as
participant's wrist. The provider started with the elbow possible while holding it for 10 seconds then waited for a few
slightly flexed, took it to full extension, and applied the thrust seconds and repeated this 10 times maximum.
at the end range while extending the elbow and pronating the To exercise the supinator and pronator muscles of the
forearm. This HVLA manipulation of the elbow is a modified forearm with isometric contraction at the end range,
combination of Cyriax's second manipulation and Kalthen- participants sat in a chair with the upper body in a sound
born's manipulation77 and could be described as a grade 5 postural alignment. 81 Using an imbalanced adjustable
mobilization.78,79 Mobilization treatment of lateral epicon- dumbbell weight (a hammer) with a maximum weight of
dylitis is not a new concept77,80-84 and possible effectiveness 700 g, participants moved from the end range of supination
576 Radpasand and Owens Journal of Manipulative and Physiological Therapeutics
Chronic Tennis Elbow September 2009

Fig 2. Elbow brace with a pad.

to the end range of pronation while the wrist was fixed rigid
and aligned with the forearm. The participants had the full
active control of the weight. The elbow was supported at the
edge of the table while the arm and forearm make a 90° angle Fig 3. Customary placement of the elbow brace.
with each other. The duration per repetition was 10 seconds
with 10 repetitions maximum. At the end of the action, the
participants squeezed the imbalanced weight as tightly as
possible while holding it for 10 seconds, then waited for a
few seconds and repeated this 10 times maximum.
Participants also performed therapeutic putty exercises
for the wrist with isometric contraction at the end range.
Participants sat in a chair with the upper body in a sound
postural alignment. The arm and forearm were held at a 90°
angle to each other with the wrist extended as far as
possible while holding the putty. The putty was pushed
toward the thenar surface of the palm of the hand by flexing
the second through fifth digits as hard as possible, holding it
there for 10 seconds and then releasing and waiting a few
seconds. This was repeated 5 times. The goal was to have
the participants maintain the duration of 10 seconds, with
10 repetitions maximum. In case the participants could not
perform that many repetitions, the clinician instructed the Fig 4. Placement of elbow brace with hard pad over.
participants to start with 5 repetitions and increase by one
repetition each day up to 10 repetitions maximum. The
progressions in load imposed on the muscles could be and pain-conducting nerve fibers. In this study, we used 150
achieved by increasing the number of repetitions starting Hz, for 10-second duration at 19 to 29 mA, for the
from 5 to 10, according to the participants' tolerance. For participants' tolerance.
the putty exercise, we used Penn Ultra-Blue Racquet balls
(Penn Racquet Sports, Phoenix, Ariz). Counterforce Bracing. Between treatments, patients used
In our multimodal treatment protocol, we used the a counterforce elbow brace with the hard pad's knob (Fig 2)
standard HVPGS (LSI II manufactured by LSI International exactly located on top of the most painful area (Fig 3), not
Inc, Overland Park, Kan) for wound healing, for edema in line with the lateral epicondyle, over the proximal one
reduction, for pain relief, to deter formation of adhesion, for third of forearm, which is customary18,20 (Fig 4). Placing
promotion of collagen synthesis with moderate changes in the brace over the ECRB holds the muscle incretion in its
tendon biomechanics89 along with reduction of spasm42,90 place, and holds the elbow in partial flexion, which prevents
immediately after the HVLA manipulation. Devices in this strain and sudden lengthening of the elbow extensor
class are characterized by a unique twin-peak monophasic muscle. The brace was used as a supportive therapy.
waveform with very short pulse duration (microseconds) and Biomechanical studies support the placement of counter-
a therapeutic voltage greater than 100 V. The combination of force bracing, especially with some form of padding
very short pulse duration and high-peak current, yet low total directly over ECRB and show that it reduces the stress
current per second (microcurrent), allows for relatively and forces on the ECRB.91-93 For the counterbalance, we
comfortable stimulation. Furthermore, this combination used the Nexcare Elbow Brace with pad (3M Consumer
provides an efficient means of exciting sensory, motor, Health Care, St Paul, Minn).
Journal of Manipulative and Physiological Therapeutics Radpasand and Owens 577
Volume 32, Number 7 Chronic Tennis Elbow

Icing/Cryotherapy. Each participant was instructed to put


an ice cup over the lateral epicondyle, small enough to cover
only the lateral epicondyle, and to apply it for maximum of
10 minutes. Each was told to remove the ice cup for 15
minutes, repeat 2 times, and to perform this procedure 3
times per day. Each was instructed to have minimal usage of
their affected elbow. Ice was used to decrease inflammation
around the elbow due to its vasoconstrictive role, and based
on the available evidence, cryotherapy seems to be effective
in decreasing pain.94 The evidence of systematic review
suggests that melting iced water applied through a wet towel
for repeated periods of 10 minutes is most effective.95
However, ice was applied cautiously because of the
proximity of the relatively superficial nerve tissue. Nerve
palsies and frostbite after direct ice treatment at very low
temperatures have been reported.96,97

Multimodal Group B

Overview. Participants were seen 3 times per week for 4


weeks, then twice per week for 3 weeks, and finally once per Fig 5. Recruitment flow chart.
week for 4 weeks. This group was treated with ultrasound,
brace, and exercise. The ultrasound was set at 3 MHz, 1.5 W/
cm 2 , and pulsed mode of 1 millisecond on and 5 ultrasound gel, to provide effective conduction between the
milliseconds off. At the end of week 7, participants were ultrasound head (transducer) and the skin,108 whereas the
seen once a week, and the putty therapeutic exercise was head of the ultrasound probe was kept in constant motion and
added. At the end of week 8, participants could remove the in contact with the skin, angled at 90° to the treatment area
brace while at home and wear it while doing daily activities. (the palpable point over the tendon at the junction of ECRB)
They resumed light daily activities with the involved hand to minimize the risk of causing hot spots (undue temperature
and had the brace off completely at the end of week 10. At rise in a single volume of tissue receiving excess
the end of week 12, participants received final treatment and exposure).109 In our study, we used the Intelect Transport
all outcome measurements were assessed. Visit frequency (Chattanooga Group, Hixson, Tenn).
was the same as group A, with bracing all the same. The effects of the ultrasound in the treatment of tennis
elbow have been investigated extensively.28,102,103,110-116
Ultrasound. Ultrasound is a deep heating modality that is Ultrasound provides modest pain reduction over 1 to 3
most effective in heating tissues of deep joints.98 It causes months114,117; however, for the pain reduction, exercise
increases in tissue relaxation, local blood flow, scar tissue along with the ultrasound appears to be more effective than
breakdown, protein synthesis, fibroblast activation,35 and ultrasound alone, or placebo,28,102,113,115 and combining
possible effect on tendon healing.99 The effect of the ultrasound with deep friction massage or corticosteroids is
increase in local blood flow can be used to help reduce local not better than ultrasound alone.115,117
swelling and chronic inflammation.100 A typical ultrasound
treatment will take from 3 to 5 minutes. In our case, where
scar tissue breakdown is the goal, the treatment time will be Statistical Analysis
much longer for the maximum of 8 minutes. In our study, the Data collected at first baseline were age, sex, education,
ultrasound was applied at a dosage of 3 MHz, 1.5 W/cm2, ethnicity, race information, health history (including previ-
and pulsed mode of 1 millisecond on and 5 milliseconds ous medical history and chiropractic experience), physical
off.101-103 The area of the transducer head was 2 cm2.101,102 signs, and symptoms. Symptom status during activities of
Low-intensity pulsed ultrasound accelerated ligament104 and daily living was collected by participant self-report and used
stress fracture healing.105,106 With pulsed mode, the waves to describe our participants' sample and as a mechanism to
are transmitted in short or intermittent transmissions that assess our recruitment methods. At the second baseline visit,
prevent the tissues from heating but still provide mechanical the physical signs and symptoms were obtained by a
effects such as greater permeability of cell walls.107 standard physical examination on all eligible participants
Participants sat in a chair during the procedure. Articles of by a study clinician. These examinations included height and
clothing and jewelry were removed. The therapist cleansed weight, vital signs, orthopedic, and neurologic testing. Plain
the area to be treated and applied a coupling agent, such as film radiographic studies were performed if the study
578 Radpasand and Owens Journal of Manipulative and Physiological Therapeutics
Chronic Tennis Elbow September 2009

clinician found indications for them. Upon physical Table 1. Baseline characteristics of participants with chronic
examination or medical history, the baseline PFGS test tennis elbow
along with patient self-report, VAS_24hs questionnaire, and Frequency n = 5
the PRTEE was performed. The 2 primary outcome Variables Group A Group B Overall
assessments were the PFGS test and the PRTEE. The Sex
VAS_24hs (second participant self-report) was used as Female 0 1 1
Male 3 1 4
secondary outcome measurement.
PFGS was measured at the baseline and at the end of the Ethnicity
third, sixth, ninth, and twelfth visits. Median baseline values Hispanic or Latino 1 0 1
Not Hispanic or Latino 2 2 4
and their range for the 3 grip strength attempts were
analyzed. PRTEE was conducted every week, and Race
VAS_24hs (second participant self-report) was collected White 3 2 5
every time the participant came for testing before the Educational level
treatment. The VAS_24hs, along with the total PRTEE and Trade or technical school 1 0 1
its pain and function subscales were analyzed. The function Some college 1 1 2
Professional or 1 1 2
subscale was further broken down into specific activity and Graduate degree
usual activity. Data were analyzed using SPSS version 15.0
(SPSS Inc, Chicago, Ill). Employment status
Full time 1 2 3
A sample size was estimated after the study was over, Part-time 2 0 2
based on setting the significance level α value at 5% or .05,
and type II error, the β value, where the power would be 1 − Main occupation (or was, if not currently employed)
β. We used the maximum SD to estimate the variability in the Professional/technical
Administrative/managerial
2
0
1
1
3
1
response of interest and tried to use the minimum mean Sales/service 1 0 1
difference—mean in group A minus mean in group B—in the
Smoke (cigars, pipes, or use smokeless tobacco)
measurements so that we could assess the minimum number No 2 2 4
of patients we needed.118-121 SAS V9.1.3 (SAS Institute Inc, Yes 1 0 1
Cary, NC) was used for the sample size calculation.
Age (median [range]) 38.0 (9.0) 44.5 (7.0) 39 (18)

Months of elbow pain 12.0 (6.0) 15 (18) 12 (18)


RESULTS (median [range])
For our 52-day recruitment window, 10 participants were Dominant hand
phone screened, with 1 excluded at the phone screen, 1 was Right 2 2 4
no-call no-show, and 8 were examined at the first baseline Left 0 0 0
Ambidextrous 1 0 1
visit. Of the 8 participants, 2 were no-call no-show for the
second baseline visit. After the second baseline visit, 1 Involved elbow
participant was excluded at case review due to bilateral Right 2 2 4
Left 1 0 1
elbow symptoms, 5 were enrolled, 1 dropped out after 4
weeks of treatment because of unexpected overseas travel, BMI (median [range]) 37.9 (34.15) 24.6 (2.92) 26.2 (37.1)
and 4 completed the treatment protocols (Fig 5). Therefore,
Baseline PFG (kg) (median [range])
we had 50% enrollment rate. Distribution of responses Average of 3 trials, 48.7 (60.7) 16.0 (22.7) 29.3. (85.3)
consisted of 3 from fliers and 7 from advertisement. right hand
A baseline characteristic summarizes 5 enrolled partici- Average of 3 trials, 49.7 (54.3) 38.0 (56.0) 46.0 (80.0)
left hand
pants: 1 female and 4 male white, with participants having a
median age of 39 years and elbow pain for a median of 12 VAS_24hs (median [range])
months. All participants were employed. Mainly, the Least pain 6.0 (13.0) 23.0 (14.0) 13.0 (30.0)
Worst pain 24.0 (63.0) 56.0 (8.0) 52.0 (63.0)
dominant hand was the involved elbow (Table 1). Baseline
characteristics of participants' jobs descriptions show PRTEE (median [range])
working posture and the repetition of work-activity demands Pain component (PN) 13.0 (14.0) 17.0 (4.0) 15.0 (14.0)
Specific activity 10.0 (29.0) 12.0 (2.0) 10.0 (29.0)
were the main reasons for this condition as perceived by component (SA)
them (Table 2). Usual activity 7.0 (9.0) 11 (2.0) 10 (9.0)
Compliance with visit protocols was good at about 98%, component (UA)
Total a 21.5 (33.0) 28.5 (2.0) 40.0 (52.0)
with only 2 of 24 visits missed over the 12 weeks (3-month
period) of treatment. We had success with the forms because BMI, Body mass index.
 
a SA + UA
all the participants filled all the spaces with no questions Total = PN+ .
2
asked and with minimal missed data.
Journal of Manipulative and Physiological Therapeutics Radpasand and Owens 579
Volume 32, Number 7 Chronic Tennis Elbow

Table 2. Baseline characteristics of participants' job description


Frequency n = 5
Variables 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 Fig 6. Pain-free grip strength change.

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 Fig 7. Patient-Rated Tennis Elbow Evaluation total change.
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 Fig 8. Visual analog scale change (24 hours) worst pain.
therapies for CLE (a 12-week multimodal conservative
management in a specific sequence) and to estimate the ment including advertisements in a free weekly newspaper
effect size and variability for future larger clinical studies. that were distributed in professional/technical communities.
Our recruitment may have been skewed toward producing In future trial we will need to allocate funds for advertising to
white-collar participants. We used free methods of recruit- increase the recruitment rate, in addition to directing our
580 Radpasand and Owens Journal of Manipulative and Physiological Therapeutics
Chronic Tennis Elbow September 2009

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.

recruitment strategy toward attracting blue-collar industry reinforcement of either the exercises or the ice protocols.
participants. Our possible success in having few drop-outs We realize that this may be a shortcoming on our part.
was that we explained the complex 12-week (3 months) However, at each treatment visit, the examiner asked about
treatment schedule up front before the start-up, negotiated either exercise or the ice, and whether there had been any
the time schedule, and gave them a copy of their 3-month problem following through. In our future study, we will
schedule. In addition, we explained the pathogenesis of explore the use of registered diary for measuring participant
tendinosis and rationale behind the prolonged treatment compliances. In addition, although the 12-week treatment
schedule. We think pretesting the forms was a success duration is the usual treatment protocol for chronic tennis
because we had minimal missing data. Even with the small elbow, there is a need for at least a 6-month follow-up to
sample size of our participants, our findings were similar to see if changes that occurred were sustainable overtime
other studies' finding2-4,14,122 with regard to age, duration of because a 54% chance of recurrences has been reported in
elbow pain, involvement of the dominant elbow, association “cured ” patients within 6 months.126 However, because of
with repetitive movements of the hands or wrist, and the time limitations, we were unable to do this. In addition, we
occurrence of right-sided epicondylitis twice more frequent- could not justify having a placebo group because of the
ly than left-sided epicondylitis. lengthy treatment schedule. These issues will be addressed
We did see a difference in PFGSs at baseline between the in a larger-scale study.
groups. The painful elbow showed less strength than the Although this pilot study was not designed to address the
nonpainful one, as expected. Some studies had found effectiveness of the counterforce bracing, we wish to explain
association with decreased grip strength and lateral the rationale behind the counterforce bracing placement
epicondylitis.123,124 Therefore, improvement in grip strength position. Cumulative overuse or misuse may cause displace-
measurement could reflect good treatment outcomes.125 In ment or avulsion at the muscle origin, as in Osgood
addition, the PRTEE scores within the groups correlate with Schlatter's, and consequently could result in a decrease in
the severity of the elbow pain: as PFGS decreases, PRTEE microcirculation and anaerobic metabolism in the extensors.
increases. This inverse relationship was also apparent at the Tearing of muscle fibers has been seen at the musculotendi-
end point because as PRTEE decreased the PFGS increased. nous interface.127 The mechanism of injury is due to the
Participants' compliance with the treatment and study excessive eccentric muscular interaction that leads to
protocols appear to be high because there was no considerable ultrastructural changes to skeletal muscle,
expression of dissatisfaction on being in either of the which is an injury-delayed onset of muscle soreness.128
groups. Participants adhered well to treatment schedule Placing the hard knob padded counterforce brace on the
because there was only one dropout. Although we origin site, or at the lateral epicondyle area, is intended to
distributed an exercise booklet and explained all the keep the muscle origin in its place, and when the ECRB
exercises properly, we did not use a diary for the contracts, the brace would stop the muscle from pulling away
Journal of Manipulative and Physiological Therapeutics Radpasand and Owens 581
Volume 32, Number 7 Chronic Tennis Elbow

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.

from its attachment. If the relief of tensile stress on the In regard to the sample size, we at least need 123
attachment helps to decrease pain, it may, at the same time, participants per group to encompass the PFGS calculation.
promote formation of tissue regeneration by increasing the Therefore, for our future larger RCT, we will need a
microcirculation in the area. As Fess and McCollum129 minimum of n = 246 participants, and we will try to launch a
indicated, immobilization allows healing and splinting has a multicentric clinical trial.
positive influence on collagen remodeling through applica-
tion 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
CONCLUSION
tissue growth. Pretesting the forms before the study began was valuable
In contrast, the placement of the counterforce brace in a because it resulted in refinement of items and the
customary place (in line with the lateral epicondyle, over the participants' instructions, which in turn minimized missing
proximal one third of forearm)18,20 would dampen the data. It appears the study protocol and forms used in this
already weakened muscle activity and create more disability. study are sufficient and effective, allowing us to capture the
As Walther et al93 has found, bracing with padding on the required information and would subsequently support a
forearm provides the highest reduction of acceleration larger RCT.
amplitude, and acceleration integrals as compared to padding This study is feasible because we were able to recruit
on the lateral epicondyle. chronic participants. The recruitment rate in our center was
The exercises used in this protocol, in addition to their approximately 1 participant per 10 days with minimal effort,
gradual sequential format and end point of contraction, or expenses in the participant recruitment procedure, and
encompass most elbow activities including supination, there were minimal missed visits. In addition, both
pronation, elbow/wrist extension-flexion, and ulnar/radial multimodal packages appear to reduce pain and increase
deviation. These exercises put the ECRB and extensor carpi functional ability. Therefore, further investigation of these
radialis longus under the maximal muscle strain.130 Placing treatment packages seems feasible and warranted.
these muscles under the maximal strain after a period of pain Although RCTs comparing different treatment strategies
reduction and collagen remodeling has the greatest biome- for lateral epicondylitis have previously been done, to our
chanical effect on increasing functions. One must indicate knowledge, none of the previous studies tried to incorpo-
that these exercises must be performed in a continuous nature rate the HVLA manipulation within the combination
for a minimum of 6 months after the end of treatment to see package of treatment in one of the treatment groups and
the maximal effectiveness. In addition, our study supports used this combination of outcome measurements, as well as
apparent idea of combined effect of exercise and ultrasound using the placement of the counterforce brace, as we have
in the pain reduction.28,113,115 done in this study. Our treatment protocol was toward
582 Radpasand and Owens Journal of Manipulative and Physiological Therapeutics
Chronic Tennis Elbow September 2009

breaking down tendinosis cycle rather than inflammation. 13. Kivi P. The etiology and conservative treatment of humeral
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14. Shiri R, Viikari-Juntura E, Varonen H, Heliovaara M.
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the functional components of this condition in our 15. Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron
multimodal packages of treatment of CLE. In addition, M, Melchior M, et al. Epidemiologic surveillance of upper-
our exercise protocols cover most elbow activities includ- extremity musculoskeletal disorders in the working popu-
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FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST 19. Hooftman WE, van Poppel MN, Van der Beek AJ, Bongers
PM, van Mechelen W. Gender differences in the relations
The authors declare that they have no competing interest. between work-related physical and psychosocial risk factors
This study was supported by a grant from the National and musculoskeletal complaints. Scand J Work Environ
Institutes of Health (NIH) (K30-AT-00977-04) and was Health 2004;30:261-78.
20. Gabel GT. Acute and chronic tendinopathies at the elbow.
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from National Center for Research Resources, NIH. latve trauma disorders of upper extremity. JAMA 1992;267:
838-42.
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