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

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: mohsen.radpasand@gmail.com8 eowens@nwhealth.edu). 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 handdominant and left handdominant 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 value at 5% or .05, and type II error, the value, where the power would be 1 . We used the maximum SD to estimate the variability in the response of interest and tried to use the minimum mean differencemean in group Aminus mean in group Bin 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 112 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 Group A Group B Overall Working posture: arm lifted in front of body 1/4 to 1/2 of time 2 0 2

3/4 to almost all the time 1 2 3 Working posture: hands bended or twisted 1/4 to 1/2 of time 2 1 3 3/4 to almost all the time 0 1 2 Repetitive movements: movement of fingers or hands 1/4 to 1/2 of time 2 0 2 3/4 to almost all the time 1 2 3 Repetitive movements: some movement of arms 1/4 to 1/2 of time 2 2 4 3/4 to almost all the time 1 0 1 Work activity demands Light repetitive 2 1 3 Heavy intermediate 0 1 1 Heavy repetitive 1 0 1

The multimodal group B had elbow pain for a longer duration, lower PFGS score at the baseline, and slightly higher PRTEE on all levels compared with multimodal group A. Both multimodal package groups demonstrate changes in all of the outcome variables from the baseline to the end point (12 weeks) of treatment (Figs 6-8). For the multimodal package group A, there was a 59% change for PRTEE total, 3.2% change for PFGS, and 51.4% VAS_24hs worst pain felt compared to 9.5%, 169.0%, and 65.1%, respectively, for the multimodal package group B (Tables 3 and 4). The painful elbow showed less strength than the nonpainful one, and it is noticeable that there is an inverse relationship between PRTEE and PFGS, as we would expect. With the use of PFGS to estimate sample size, n = 69 in each 2 groups and with the use of PRTEE total, n = 123 in each 2 groups. Therefore, it is recommended that at least 123 participants (some more would be ideal considering the potential loss to follow-up) be recruited for each 2 groups in a future study to achieve a power of .80; that is, a real significant difference in terms of PFGS and PRTEE between the 2 groups/treatments.

DISCUSSION
Our purpose was to develop and test protocols for a randomized clinical trial (RCT) of combined multimodal therapies for CLE (a 12-week multimodal conservative management in a specific sequence) and to estimate the effect size and variability for future larger clinical studies. Our recruitment may have been skewed toward producing white-collar participants. We used free methods of recruitment including advertisements in a free weekly newspaper that were distributed in professional/technical communities. In future trial we will need to allocate funds for advertising to increase the recruitment rate, in addition to directing our Table 2. Baseline characteristics of participants' job description
Variables Frequency n = 5 Group A Group B Overall Working posture: arm lifted in front of body

1/4 to 1/2 of time 2 0 2 3/4 to almost all the time 1 2 3 Working posture: hands bended or twisted 1/4 to 1/2 of time 2 1 3 3/4 to almost all the time 0 1 2 Repetitive movements: movement of fingers or hands 1/4 to 1/2 of time 2 0 2 3/4 to almost all the time 1 2 3 Repetitive movements: some movement of arms 1/4 to 1/2 of time 2 2 4 3/4 to almost all the time 1 0 1 Work activity demands Light repetitive 2 1 3 Heavy intermediate 0 1 1 Heavy repetitive 1 0 1

Fig 6. Pain-free grip strength change. Fig 7. Patient-Rated Tennis Elbow Evaluation total change. Fig 8. Visual analog scale change (2 Table 3. Outcome variables for multimodal group A
Variables Mean (SD) Change from baseline to end point % Change VAS_24hs_least at baseline 9.0 (4.3) VAS_24hs_least at end point 7.5 (5.0) 1.5 a 16.7 VAS_24hs_worst at baseline 34.0 (25.5) VAS_24hs_worst at end point 21.5 (16.3) 17.5 a 51.4 PRTEE pain component at baseline 19.0 (8.5) PRTEE pain component at end point 8.0 (2.9) 11.a 58.0 PRTEE special activity component at baseline 22.5 (17.7) PRTEE special activity component at end point 6.5 (2.1) 16.a 71.1 PRTEE usual activity component at baseline 11.0 (5.7) PRTEE usual activity component at end point 7.0 (2.8) 4.a 36.3 PRTEE total at baseline 35.8 (20.1) PRTEE total at end point 14.8 (5.3) 21.a 59.0 PFGS at baseline 56.2 (18.0) PFGS at end point 58.0 (34.4) +1.8 b 3.2 a Negative: improved. b Positive: increased functionimproved. 4 hours) worst pain

recruitment strategy toward attracting blue-collar industry participants. Our possible success in having few drop-outs was that we explained the complex 12-week (3 months) treatment schedule up front before the start-up, negotiated the time schedule, and gave them a copy of their 3-month schedule. In addition, we explained the pathogenesis of tendinosis and rationale behind the prolonged treatment schedule. We think pretesting the forms was a success because we had minimal missing data. Even with the small sample size of our participants, our findings were similar to other studies' finding2-4,14,122 with regard to age, duration of elbow pain, involvement of the dominant elbow, association with repetitive movements of the hands or wrist, and the occurrence of right-sided epicondylitis twice more frequently than left-sided epicondylitis. We did see a difference in PFGSs at baseline between the groups. The painful elbow showed less strength than the nonpainful one, as expected. Some studies had found association with decreased grip strength and lateral

epicondylitis.123,124 Therefore, improvement in grip strength measurement could reflect good treatment outcomes.125 In addition, the PRTEE scores within the groups correlate with the severity of the elbow pain: as PFGS decreases, PRTEE increases. This inverse relationship was also apparent at the end point because as PRTEE decreased the PFGS increased. Participants' compliance with the treatment and study protocols appear to be high because there was no expression of dissatisfaction on being in either of the groups. Participants adhered well to treatment schedule because there was only one dropout. Although we distributed an exercise booklet and explained all the exercises properly, we did not use a diary for the reinforcement of either the exercises or the ice protocols. We realize that this may be a shortcoming on our part. However, at each treatment visit, the examiner asked about either exercise or the ice, and whether there had been any problem following through. In our future study, we will explore the use of registered diary for measuring participant compliances. In addition, although the 12-week treatment duration is the usual treatment protocol for chronic tennis elbow, there is a need for at least a 6-month follow-up to see if changes that occurred were sustainable overtime because a 54% chance of recurrences has been reported in cured patients within 6 months.126 However, because of time limitations, we were unable to do this. In addition, we could not justify having a placebo group because of the lengthy treatment schedule. These issues will be addressed in a larger-scale study. Although this pilot study was not designed to address the effectiveness of the counterforce bracing, we wish to explain the rationale behind the counterforce bracing placement position. Cumulative overuse or misuse may cause displacement or avulsion at the muscle origin, as in Osgood Schlatter's, and consequently could result in a decrease in microcirculation and anaerobic metabolism in the extensors. Tearing of muscle fibers has been seen at the musculotendinous interface.127 The mechanism of injury is due to the excessive eccentric muscular interaction that leads to considerable ultrastructural changes to skeletal muscle, which is an injury-delayed onset of muscle soreness.128 Placing the hard knob padded counterforce brace on the origin site, or at the lateral epicondyle area, is intended to keep the muscle origin in its place, and when the ECRB contracts, the brace would stop the muscle from pulling away Table 3. Outcome variables for multimodal group A
Variables Mean (SD) Change from baseline to end point % Change VAS_24hs_least at baseline 9.0 (4.3) VAS_24hs_least at end point 7.5 (5.0) 1.5 a 16.7 VAS_24hs_worst at baseline 34.0 (25.5) VAS_24hs_worst at end point 21.5 (16.3) 17.5 a 51.4

PRTEE pain component at baseline 19.0 (8.5) PRTEE pain component at end point 8.0 (2.9) 11.a 58.0 PRTEE special activity component at baseline 22.5 (17.7) PRTEE special activity component at end point 6.5 (2.1) 16.a 71.1 PRTEE usual activity component at baseline 11.0 (5.7) PRTEE usual activity component at end point 7.0 (2.8) 4.a 36.3 PRTEE total at baseline 35.8 (20.1) PRTEE total at end point 14.8 (5.3) 21.a 59.0 PFGS at baseline 56.2 (18.0) PFGS at end point 58.0 (34.4) +1.8 b 3.2 a Negative: improved. b Positive: increased functionimproved. from its attachment. If

the relief of tensile stress on the attachment helps to decrease pain, it may, at the same time, promote formation of tissue regeneration by increasing the microcirculation in the area. As Fess and McCollum129 indicated, immobilization allows healing and splinting has a positive influence on collagen remodeling through application of low-load forces. They go on to emphasize that no other currently available modality is able to hold a constant low-load tension for a prolonged time sufficient to cause tissue growth. In contrast, the placement of the counterforce brace in a customary place (in line with the lateral epicondyle, over the proximal one third of forearm)18,20 would dampen the already weakened muscle activity and create more disability. As Walther et al93 has found, bracing with padding on the forearm provides the highest reduction of acceleration amplitude, and acceleration integrals as compared to padding on the lateral epicondyle. The exercises used in this protocol, in addition to their gradual sequential format and end point of contraction, encompass most elbow activities including supination, pronation, elbow/wrist extension-flexion, and ulnar/radial deviation. These exercises put the ECRB and extensor carpi radialis longus under the maximal muscle strain.130 Placing these muscles under the maximal strain after a period of pain reduction and collagen remodeling has the greatest biomechanical effect on increasing functions. One must indicate that these exercises must be performed in a continuous nature for a minimum of 6 months after the end of treatment to see the maximal effectiveness. In addition, our study supports apparent idea of combined effect of exercise and ultrasound in the pain reduction.28,113,115 In regard to the sample size, we at least need 123 participants per group to encompass the PFGS calculation. Therefore, for our future larger RCT, we will need a minimum of n = 246 participants, and we will try to launch a multicentric clinical trial.

CONCLUSION
Pretesting the forms before the study began was valuable because it resulted in refinement of items and the participants' instructions, which in turn minimized missing

data. It appears the study protocol and forms used in this study are sufficient and effective, allowing us to capture the required information and would subsequently support a larger RCT. This study is feasible because we were able to recruit chronic participants. The recruitment rate in our center was approximately 1 participant per 10 days with minimal effort, or expenses in the participant recruitment procedure, and there were minimal missed visits. In addition, both multimodal packages appear to reduce pain and increase functional ability. Therefore, further investigation of these treatment packages seems feasible and warranted. Although RCTs comparing different treatment strategies for lateral epicondylitis have previously been done, to our knowledge, none of the previous studies tried to incorporate the HVLA manipulation within the combination package of treatment in one of the treatment groups and used this combination of outcome measurements, as well as using the placement of the counterforce brace, as we have done in this study. Our treatment protocol was toward Table 4. Outcome variables for multimodal group B
Variables Mean (SD) Change from baseline to end point % Change VAS_24hs_least at baseline 23.0 (9.9) VAS_24hs_least at end point 10.5 (10.7) 12.5 a 54.3 VAS_24hs_worst at baseline 56.0 (5.7) VAS_24hs_worst at end point 19.5 (22.0) 36.5 a 65.1 PRTEE pain component at baseline 17.0 (2.9) PRTEE pain component at end point 7.5 (5.0) 9.5 a 56.0 PRTEE special activity component at baseline 12.0 (4.2) PRTEE special activity component at end point 6.5 (0.8) 5.5 a 46.0 PRTEE usual activity component at baseline 11.0 (1.4) PRTEE usual activity component at end point 6.5 (0.7) 4.5 a 41.0 PRTEE total at end point 28.5 (1.4) PRTEE total at end point 14.2 (28.1) 2.7 a 9.5 PFGS at baseline 16.0 (16.0) PFGS at end point 43.5 (41.7) +27.b 169.0 a Negative: improved. b Positive: increased functionimproved. 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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