Combined Multimodal Therapies for Chronic Tennis

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

1% and 10%, depending on the age group investigated.11

Women are more often affected than men, with a peak

prevalence at age 42 to 44 (range, 30-50 years) of 9% and

3%, respectively.11,14,16-18 These differences may be due to

factors related to employment, psychological-physiological,

cultural, and biological factors.17,19 The dominant arm is

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

hobby, whereas the remaining (20%) are related to direct or

indirect acute injuries.20

In the United States, work-related disorders of the upper

extremities account for more than 50% of all occupational

illnesses.21 In particular, in female workers, the claims for

epicondylitis have increased by 125% from 1988 to 1995.

Despite the epidemic, a comprehensive treatment of

epicondylitis has not been well established.22,23 More than

40 different treatments used separately or in combination

aiming to reduce pain and increase function have been

described.24-27 With all the clinical heterogeneity and overall

inconclusive finding of the reviews, there are a few valid a Private practice, Shipman Chiropractic Clinic, Davenport, Iowa

52807.

b Director, Office of Data Management Wolf-Harris Center for

Clinical Studies Northwestern Health Sciences University, Bloomington,

Minn 55431.

Submit requests for reprints to: Mohsen Radpasand, DC, MD,

MCR, Shipman Chiropractic Clinic, 1850 East 53rd; Suite 2,

Davenport, Iowa 52807, USA

(e-mails: [email protected] [email protected]).

Paper submitted February 20, 2009; in revised form May 23,

2009; accepted June 8, 2009.

0161-4754/$36.00

Copyright © 2009 by National University of Health Sciences.

doi:10.1016/j.jmpt.2009.08.010

571studies that suggest potential effectiveness of treatment28;

however, the optimal treatment remains undefined.26

The pathophysiology of this condition is not well

understood. However, it has been suggested that the factors

leading to lateral epicondylitis are more cumulative in nature

rather than from occasional trauma.29,30 It is known that

repetitive and sustained contraction of the extensor carpi

radialis brevis (ECRB) and extensor digitorum communis

muscles contribute to the signs and symptoms associated

with this condition.1,7,31-34 This overuse tendinopathy is

tendinosis or collagen degeneration rather than tendinitis or

inflammation in nature.35,36 There are 2 nontraumatic

biomechanical theories for the pathogenesis of lateral

epicondylitis.37 The first one is tensile loading, which

postulates that tearing of the extensor muscle tendons arising

from eccentric movements exceeds an endurable rate of

strain of the tendons fibers.7,34 This theory supports the

repetition aspect of the cause rather than duration. The

second one is radial head compression, which postulates the

creation of compression between the radial head, annular

ligament, and ECRB aponeurosis due to the tensile loading

of extensor muscles in combination with elbow extension,

pronation, and supination.38,39

This pilot study describes the development and testing of

protocols for a simple systematic multimodal package of

treatment consisting of 12 weeks of conservative management

in a specific sequence for chronic lateral epicondylitis

(CLE) using a high-velocity low-amplitude manipulation

(HVLA), high-voltage pulse galvanic stimulation

(HVPGS), counterforce brace, ice, and exercises for group

A, and ultrasound, counterforce brace, and exercise for

group B. Both groups had instructions to restrict usage of

the affected elbow.

METHODS

Overview of Research Design We developed this pilot study to test forms and

procedures to be used in a future trial and to test the success

of recruitment strategies, screening procedures, and feasibility

of the 12-week proposed treatment plan. We designed

several forms and modified others to suit our study. The

designed forms were the physical examination, pain-free grip

strength (PFGS), visual analog scale (VAS_24hs), baseline

consent form for visit 1, baseline consent form for visit 2,

and a clinician questionnaire. The modified forms consisted

of the verbal instruction for the PFGS, the Patient-Rated

Tennis Elbow Evaluation (PRTEE), a telephone screening

form, and patient withdrawal form. All forms were read for

grammar and material content by the acting director of the

research clinic, a fellow at the research center, the study

coordinator, and other research center staff, and were

pretested on a few patients. A research center faculty

member who is an expert in bioethics read the consent forms

for grammar and material contents. The college institutional

review board approved the study protocol and all the forms.

During the first baseline visits, we had participants sign

the first consent form and fill out the demographic form

and clinician questionnaire. After having their eligibility

confirmed during case review sessions, at the second

baseline visit, we had them sign the second consent form,

and we conducted the clinical examination and obtained

baseline measures. Each participant was then allocated

randomly to one of the package groups and received their

first treatment. The sequence of the assignment was a

predetermined randomization scheme (using a random

number table) in a 1:1 allocation ratio. All participants

were randomized by the use of sealed, opaque, sequentially

numbered envelopes. At each visit, all the participants were

requested to fill out the VAS_24hs questionnaire, and every

week the participant also filled out the PRTEE. The PFGS

test was measured at the baseline and at the end of third,

sixth, ninth, and twelfth visits (Fig 1). All the data were

collected by the study coordinator and then transferred in

an opaque envelope to the data manager. The clinician was

blinded to the data, and the participants were instructed not

to discuss anything related to the data collection procedures

with their clinician.

Study Population Participants from the Quad City metropolitan area (a

population of 300 000 people) with CLE were recruited

from May 5 to June 25, 2008, using fliers and free

weekly newspaper ads. The ads were distributed in

professional/technical communities. CLE refers to the

condition with the duration of pain of at least 6 months.

The participants were enrolled provided they met the

diagnostic conditions, in addition to the inclusion and

exclusion criteria described below.

Diagnosis of Lateral Epicondylitis Participants with pain for a duration of at least 6 months,

and with pain over the lateral epicondyle evoked by 2 or

more of the following 4 tests, were included in the studies:

(1) pain evoked by palpation of lateral epicondyle8; (2)

resisted wrist extension (position: shoulder flexion 60°,

nonsupported elbow extension; forearm pronated; wrist

extended about 30°; pressure applied to the dorsum of the

second and third metacarpal bones in the direction of flexion

toward the ulnar side to prove involvement of the ECRB and

longus); (3) resisted finger extension (position: 60° of

shoulder flexion, elbow extended, forearm pronated, and

finger extended; resisted extension was applied manually on

digits II to V to prove involvement of the extensor indicis,

the extensor digitorum, and the extensor digiti minimi;

resistance applied on digitus III was the middle-finger test);

and (4) pain in the region of the lateral epicondyle during

resisted extension of the middle finger (Maudsley's test

considered to be a sensitive test indicating that at least a

portion of the extensor is involved.40-42

Inclusion Criteria Inclusion criteria include history of epicondylalgia of the

radial humerus, lateral epicondyle pain at rest and during

resisted dorsiflexion of the wrist with elbow in full extension,

pain for at least 6 months, ability to read and verbally

comprehend English, and age between 21 and 65 years.

Exclusion Criteria Exclusion criteria include treatment by a health care

practitioner within the proceeding 6 months for lateral

epicondylitis, injections of corticosteroid at involved site

during the preceding 6 months, bilateral elbow symptoms,

wrist or hand pathology, signs and symptoms suggesting a

cause other than overuse (eg, cervical radiculopathy),

congenital or acquired elbow deformity, surgery or dislocation

of the elbow, tendon ruptures or fractures in the elbow

area in the preceding 12 months, known systemic disorders

of the musculoskeletal system (eg, myasthenia gravis,

osteoporosis, hemophilia, fibromyalgia, rheumatoid arthritis),

neurologic disorders (central or peripheral nervous

system diseases), immobility cast on either elbow or hand of

the involved side, pregnancy, pacemaker, or previous

experience with manipulative therapy to the elbow joint.

Selection Criteria for Provider The provider was a chiropractor with a minimum of 10

years in practice and a track record in treating upperextremity

abnormalities, especially this type of complaint.

Outcome Measures Patient-Rated Tennis Elbow Evaluation. The PRTEE was initially

developed in 1998.43 PRTEE is a simple, reliable,44,45

valid46 assessment tool that was designed specifically for

patients with lateral epicondylitis.44,47 The reliability of

PRTEE in patients with lateral epicondylitis has been

established for both the pain (intraclass correlation coefficient

[ICC], 0.89) and function (ICC, 0.83) subscales and

also for the overall score (ICC, 0.89) by the developers of the

questionnaire44 and in other studies (ICC: pain, 0.96;

function, 0.92; total, 0.96).47 The overall PRTEE and the

pain and function subscales of the PRTEE were analyzed.

The function subscale was further broken down into specific

activity and usual activity.48

A common finding with PRTEE is that patients will not

know how to answer questions related to movements they

rarely perform. This can result in missing data. We followed

MacDiarmid's48 suggestion and encouraged participants to

estimate their average difficulty of any task that is rarely

performed. We added this sentence to the form: ―If you did

not perform, an activity listed please ESTIMATE the pain or

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

in data cleaning.

Pain-Free Grip Strength__Gripping to the Point Of Pain. Pain-free

grip strength was measured with a Jamar Digital Hand

Dynamometer (serial no. 41100114; Therapeutic Equipment

Corporation, Clifton, NJ) set at the second handle

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

demonstrate greater grip strength than women at any age55-58

and grip strength diminishes curvilinearly with age.

There are few functional differences between the mean

scores of right hand–dominant and left hand–dominant

subjects.57 Injured hands are weaker than healthy hands.59,60

The standardized instrumentation, normative data, and

information on test repeatability are available for measures

of hand grip.57,61-64 In addition, there are also correlations

with stature and weight.65 In our study, we used PFGS

because PFGS is more sensitive to change than maximum

grip strength.66 Furthermore, maximum grip strength is least

valid in demonstrating change.67

In addition, we used the written instruction of Haward

et al58 read by the examiner. To capture the pain threshold

over time, we modified the instruction read by the examiner

as such: ―The purpose of this is to test your pain-free

maximum hand grip strength. You will be asked to repeat

this three times with each side beginning with your right (or

left if appropriate) side. Please hold the grip strength meter in

a comfortable position and when you are ready squeeze the

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.‖ The examiner waited 30 seconds between each measurement.

We incorporated the recommendations of Mathiowetz

et al57 and the American Society of Hand Therapists'

suggestion of standardized arm position for strength

tests.63,68 The mean values of the 3 grip strength attempts

were calculated.49 The grip strength started with the painfree

hand first. In addition to grip strength in kilograms, we

also collected data on age (years), weight (kilograms), height

(centimeters), dominant hand, and occupation. Calibration of

the dynamometer was checked regularly, and the same test

instrument was used throughout the study.

Visual Analog Scale. We used a100-mm VAS to assess pain in

the past 24 hours. VAS is a valid and reliable measure of

chronic and acute pain.69-73 We designed this form

ourselves. We took 2 of the questions from PRTEE's pain

components and asked the participants to scale them on VAS

pain scales to let us know what their pain was during the past

24 hours.

The 11-point numeric rating scale (NRS-11) and a 100- mm VAS has similar sensitivity;

therefore, choices between mm VAS has similar sensitivity; therefore, choices between the

VAS and NRS-11 can be based on subjective

preferences.74 On average, a reduction of approximately 2

points or a reduction of approximately 30% in the NRS

represents a clinically important difference.75 A mean

reduction in VAS of 30.0 mm represents a clinically

important difference in pain severity that corresponds to

patients' perception of adequate pain control. Defining

minimal clinical important differences based on adequate

analgesic control rather than minimal detectable change may

be more appropriate for future analgesic trials when effective

treatments for acute pain exist.76

Treatment Procedures Multimodal Group A Overview. Participants were seen 3 times per week for 4

weeks, then 2 times per week for 3 weeks, and then once per

week for 4 weeks. At each visit, participants received HVLA

treatment at the involved elbow. Then, the involved elbow

was placed under the HVPGS with the positive pad placed

over the lateral epicondyle and the negative pad placed at the

base of the scapula on the involved side while lying down

supine for 10 minutes. Stimulation was delivered to the

participant's tolerance. Participants were instructed how to

place the knob of a hard padded elbow counterforce brace

directly on the most painful point over the lateral epicondyle

rather than on the muscle belly. Exercise protocols were

given at the start of week 6. Each participant was instructed

to remove the brace while performing the exercises and

reapply it after the exercises. At the end of week 7,

participants were seen once a week, and the putty therapeutic

exercise was added. At the end of week 8, participants could

remove the brace while at home and wear it while doing

daily activities. They resumed light daily activities with the

involved hand and had the brace off completely at the end of

week 10. Ice was applied when needed for pain or soreness.

At the end of week 12, participants received final treatment,

and all outcome measurements were assessed.

Manipulation. Manipulation was delivered as a HVLA

thrust, using the pad of the thumb in a posterior to anterior

direction over the posterior aspect of the radial head,

approximately on top of the attachment of the extensor

tendon to the lateral epicondyle. Participants sat in a chair

with the upper body erect leaning against the chair's back.

The clinician's opposite hand held the dorsum of the

participant's wrist. The provider started with the elbow

slightly flexed, took it to full extension, and applied the thrust

at the end range while extending the elbow and pronating the

forearm. This HVLA manipulation of the elbow is a modified

combination of Cyriax's second manipulation and Kalthenborn's

manipulation77 and could be described as a grade 5

mobilization.78,79 Mobilization treatment of lateral epicondylitis

is not a new concept77,80-84 and possible effectiveness

has been demonstrated.85 The effectiveness of manipulation

may be due to the changes in biomechanical, anatomical, and

nerve relationships that result in unique hypoalgesia

effect,86,87 in addition to the possible effect on breaking

down adhesions for a chronic lesion. This HVLA manipulative

thrust has been reported previously.88

Exercises. Exercises consisted of (1) forearm supinator

and pronator muscles performed with an imbalanced

adjustable dumbbell weight, (2) forearm extensor and

flexor muscle exercises using a free standing dumbbell,

(3) forearm supinator and pronator muscle exercises using

an imbalanced adjustable dumbbell weigh (a hammer), and

(4) putty therapeutic exercise. All were performed with

isometric contraction at the end range of motion. The goal

was to maintain contractions for 10 seconds, with 10

repetitions maximum, twice a day. The goal for all the

exercise protocols 1, 2, and 3 were 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 participants to

start with the 5 repetitions and to increase by one repetition

each day up to 10 repetitions maximum. The progressions

in load imposed on the muscle could be achieved by

increasing the number of repetitions starting from 5 to 10,

according to the participants' tolerance. These procedures

have been detailed previously.88

For the forearm extensor muscle exercise with isometric

contraction at the end of range, the participant sits in a chair

with the upper body in sound postural alignment.81 The

forearm was fully stabilized and the edge of a table was

placed 3 to 6 cm away from the wrist joint. Using a freestanding

dumbbell (approximate weight, 500 g), this exercise

had 2 positions, being pure extension at the wrist and then

radial deviation and extension. At the end of the position, the

participants squeezed the dumbbell weight as tightly as

possible while holding it for 10 seconds then waited for a few

seconds and repeated this 10 times maximum.

For the forearm flexor muscle exercise with isometric

contraction at the end range, the participants sat in a chair

with the upper body in sound postural alignment.81 The

forearm was fully stabilized and the edge of a table was

placed 3 to 6 cm away from the wrist joint. Using a freestanding

dumbbell (approximate weight, 500 g), this

exercise had 2 positions, pure flexion at the wrist and then

radial deviation and flexion. At the end of the position, the

participants squeezed the dumbbell weight as tightly as

possible while holding it for 10 seconds then waited for a few

seconds and repeated this 10 times maximum.

To exercise the supinator and pronator muscles of the

forearm with isometric contraction at the end range,

participants sat in a chair with the upper body in a sound

postural alignment.81 Using an imbalanced adjustable

dumbbell weight (a hammer) with a maximum weight of 700 g, participants moved from the

end range of supination

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

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

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

achieved by increasing the number of repetitions starting

from 5 to 10, according to the participants' tolerance. For

the putty exercise, we used Penn Ultra-Blue Racquet balls

(Penn Racquet Sports, Phoenix, Ariz).

In our multimodal treatment protocol, we used the

standard HVPGS (LSI II manufactured by LSI International

Inc, Overland Park, Kan) for wound healing, for edema

reduction, for pain relief, to deter formation of adhesion, for

promotion of collagen synthesis with moderate changes in

tendon biomechanics89 along with reduction of spasm42,90

immediately after the HVLA manipulation. Devices in this

class are characterized by a unique twin-peak monophasic

waveform with very short pulse duration (microseconds) and

a therapeutic voltage greater than 100 V. The combination of

very short pulse duration and high-peak current, yet low total

current per second (microcurrent), allows for relatively

comfortable stimulation. Furthermore, this combination

provides an efficient means of exciting sensory, motor,

and pain-conducting nerve fibers. In this study, we used 150

Hz, for 10-second duration at 19 to 29 mA, for the

participants' tolerance.

Counterforce Bracing. Between treatments, patients used

a counterforce elbow brace with the hard pad's knob (Fig 2)

exactly located on top of the most painful area (Fig 3), not

in line with the lateral epicondyle, over the proximal one

third of forearm, which is customary18,20 (Fig 4). Placing

the brace over the ECRB holds the muscle incretion in its

place, and holds the elbow in partial flexion, which prevents

strain and sudden lengthening of the elbow extensor

muscle. The brace was used as a supportive therapy.

Biomechanical studies support the placement of counterforce

bracing, especially with some form of padding

directly over ECRB and show that it reduces the stress

and forces on the ECRB.91-93 For the counterbalance, we

used the Nexcare Elbow Brace with pad (3M Consumer

Health Care, St Paul, Minn).

Fig 2. Elbow brace with a pad.

Fig 4. Placement of elbow brace with hard pad over

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

week for 4 weeks. This group was treated with ultrasound,

brace, and exercise. The ultrasound was set at 3 MHz, 1.5 W/

cm2, and pulsed mode of 1 millisecond on and 5

milliseconds off. At the end of week 7, participants were

seen once a week, and the putty therapeutic exercise was

added. At the end of week 8, participants could remove the

brace while at home and wear it while doing daily activities.

They resumed light daily activities with the involved hand

and had the brace off completely at the end of week 10. At

the end of week 12, participants received final treatment and

all outcome measurements were assessed. Visit frequency

was the same as group A, with bracing all the same.

Ultrasound. Ultrasound is a deep heating modality that is

most effective in heating tissues of deep joints.98 It causes

increases in tissue relaxation, local blood flow, scar tissue

breakdown, protein synthesis, fibroblast activation,35 and

possible effect on tendon healing.99 The effect of the

increase in local blood flow can be used to help reduce local

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

much longer for the maximum of 8 minutes. In our study, the

ultrasound was applied at a dosage of 3 MHz, 1.5 W/cm2,

and pulsed mode of 1 millisecond on and 5 milliseconds

off.101-103 The area of the transducer head was 2 cm2.101,102

Low-intensity pulsed ultrasound accelerated ligament104 and

stress fracture healing.105,106 With pulsed mode, the waves

are transmitted in short or intermittent transmissions that

prevent the tissues from heating but still provide mechanical

effects such as greater permeability of cell walls.107

Participants sat in a chair during the procedure. Articles of

clothing and jewelry were removed. The therapist cleansed

the area to be treated and applied a coupling agent, such as

ultrasound gel, to provide effective conduction between the

ultrasound head (transducer) and the skin,108 whereas the

head of the ultrasound probe was kept in constant motion and

in contact with the skin, angled at 90° to the treatment area

(the palpable point over the tendon at the junction of ECRB)

to minimize the risk of causing hot spots (undue temperature

rise in a single volume of tissue receiving excess

exposure).109 In our study, we used the Intelect Transport

(Chattanooga Group, Hixson, Tenn).

The effects of the ultrasound in the treatment of tennis

elbow have been investigated extensively.28,102,103,110-116

Ultrasound provides modest pain reduction over 1 to 3

months114,117; however, for the pain reduction, exercise

along with the ultrasound appears to be more effective than

ultrasound alone, or placebo,28,102,113,115 and combining

ultrasound with deep friction massage or corticosteroids is

not better than ultrasound alone.115,117

Statistical Analysis Data collected at first baseline were age, sex, education,

ethnicity, race information, health history (including previous

medical history and chiropractic experience), physical

signs, and symptoms. Symptom status during activities of

daily living was collected by participant self-report and used

to describe our participants' sample and as a mechanism to

assess our recruitment methods. At the second baseline visit,

the physical signs and symptoms were obtained by a

standard physical examination on all eligible participants

by a study clinician. These examinations included height and

weight, vital signs, orthopedic, and neurologic testing. Plain

film radiographic studies were performed if the study clinician found indications for them.

Upon physical

examination or medical history, the baseline PFGS test

along with patient self-report, VAS_24hs questionnaire, and

the PRTEE was performed. The 2 primary outcome

assessments were the PFGS test and the PRTEE. The

VAS_24hs (second participant self-report) was used as

secondary outcome measurement.

PFGS was measured at the baseline and at the end of the

third, sixth, ninth, and twelfth visits. Median baseline values

and their range for the 3 grip strength attempts were

analyzed. PRTEE was conducted every week, and

VAS_24hs (second participant self-report) was collected

every time the participant came for testing before the

treatment. The VAS_24hs, along with the total PRTEE and

its pain and function subscales were analyzed. The function

subscale was further broken down into specific activity and

usual activity. Data were analyzed using SPSS version 15.0

(SPSS Inc, Chicago, Ill).

A sample size was estimated after the study was over,

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 − β. We used the maximum SD to estimate the variability in the

response of interest and tried to use the minimum mean

difference—mean in group Aminus mean in group B—in the

measurements so that we could assess the minimum number

of patients we needed.118-121 SAS V9.1.3 (SAS Institute Inc,

Cary, NC) was used for the sample size calculation.

RESULTS

For our 52-day recruitment window, 10 participants were

phone screened, with 1 excluded at the phone screen, 1 was

no-call no-show, and 8 were examined at the first baseline

visit. Of the 8 participants, 2 were no-call no-show for the

second baseline visit. After the second baseline visit, 1

participant was excluded at case review due to bilateral

elbow symptoms, 5 were enrolled, 1 dropped out after 4

weeks of treatment because of unexpected overseas travel,

and 4 completed the treatment protocols (Fig 5). Therefore,

we had 50% enrollment rate. Distribution of responses

consisted of 3 from fliers and 7 from advertisement.

A baseline characteristic summarizes 5 enrolled participants:

1 female and 4 male white, with participants having a

median age of 39 years and elbow pain for a median of 12

months. All participants were employed. Mainly, the

dominant hand was the involved elbow (Table 1). Baseline

characteristics of participants' jobs descriptions show

working posture and the repetition of work-activity demands

were the main reasons for this condition as perceived by

them (Table 2).

Compliance with visit protocols was good at about 98%,

with only 2 of 24 visits missed over the 12 weeks (3-month

period) of treatment. We had success with the forms because

all the participants filled all the spaces with no questions

asked and with minimal missed data. Table 1. Baseline characteristics of participants with chronic

tennis elbow Variables

Frequency n = 5

Group A Group B Overall

Sex

Female 0 1 1

Male 3 1 4

Ethnicity

Hispanic or Latino 1 0 1

Not Hispanic or Latino 2 2 4

Race

White 3 2 5

Educational level

Trade or technical school 1 0 1

Some college 1 1 2

Professional or

Graduate degree

1 1 2

Employment status

Full time 1 2 3

Part-time 2 0 2

Main occupation (or was, if not currently employed)

Professional/technical 2 1 3

Administrative/managerial 0 1 1

Sales/service 1 0 1

Smoke (cigars, pipes, or use smokeless tobacco)

No 2 2 4

Yes 1 0 1

Age (median [range]) 38.0 (9.0) 44.5 (7.0) 39 (18)

Months of elbow pain

(median [range])

12.0 (6.0) 15 (18) 12 (18)

Dominant hand

Right 2 2 4

Left 0 0 0

Ambidextrous 1 0 1

Involved elbow

Right 2 2 4

Left 1 0 1

BMI (median [range]) 37.9 (34.15) 24.6 (2.92) 26.2 (37.1)

Baseline PFG (kg) (median [range])

Average of 3 trials,

right hand

48.7 (60.7) 16.0 (22.7) 29.3. (85.3)

Average of 3 trials,

left hand

49.7 (54.3) 38.0 (56.0) 46.0 (80.0)

VAS_24hs (median [range])

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)

PRTEE (median [range])

Pain component (PN) 13.0 (14.0) 17.0 (4.0) 15.0 (14.0)

Specific activity

component (SA)

10.0 (29.0) 12.0 (2.0) 10.0 (29.0)

Usual activity

component (UA)

7.0 (9.0) 11 (2.0) 10 (9.0)

Total a 21.5 (33.0) 28.5 (2.0) 40.0 (52.0)

BMI, Body mass index. a

Total = PN+

SA + UA

2

_ _

. Table 2. Baseline characteristics of participants' job description Variables

Frequency n = 5


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


Repetitive movements: movement of fingers or hands

1/4 to 1/2 of time 2 0 2


Repetitive movements: some movement of arms

1/4 to 1/2 of time 2 2 4


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


Working posture: arm lifted in front of body

1/4 to 1/2 of time 2 0 2


Working posture: hands bended or twisted

1/4 to 1/2 of time 2 1 3


Repetitive movements: movement of fingers or hands

1/4 to 1/2 of time 2 0 2


Repetitive movements: some movement of arms

1/4 to 1/2 of time 2 2 4


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






PRTEE pain component at end point 8.0 (2.9) −11.a 58.0


PRTEE special activity component at end point 6.5 (2.1) −16.a 71.1


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 end point 58.0 (34.4) +1.8 b 3.2


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






PRTEE pain component at end point 7.5 (5.0) −9.5 a 56.0


PRTEE special activity component at end point 6.5 (0.8) −5.5 a 46.0


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 end point 43.5 (41.7) +27.b 169.0


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

supination, pronation, elbow/wrist extension-flexion,

and ulnar/radial deviation, along with the end-point

contraction, which put the ECRB and extensor carpi

radialis longus under the maximal muscle strain. Our

long-term goal is to identify a specific regimen of treatment

that is most effective in treatment of CLE and its disability.

Eventually, we are hoping to propose an evidence-based

treatment with the twin therapeutic objectives of pain relief

and functional recovery.

FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST

The authors declare that they have no competing interest.

This study was supported by a grant from the National

Institutes of Health (NIH) (K30-AT-00977-04) and was

conducted in a facility constructed with support of a

Research Facilities Improvement Grant (C06 RR15433)

from National Center for Research Resources, NIH.

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Combined Multimodal Therapies for Chronic Tennis

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