Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis

Study Overview
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Brief Summary
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No consensus has yet been built on the treatment of lateral epicondylitis (LE) due to the lack of evidence. Although conflicting results are present, radial extracorporeal shock wave therapy (rESWT) has increasingly been used in the treatment of tendinopathy

Detailed Description
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ESWT and exercise have beneficial effects on the management of tendinopathies owing to their various mechanisms that showed therapeutic efficacy. Owing to its positive outcomes, extracorporeal shock wave therapy (ESWT) has recently been used in the treatment of musculoskeletal system diseases such as plantar fasciitis, Achilles tendinopathy, calcific rotator cuff tendinopathies, and patellar tendinopathy

Official Title
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Comparison of the Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Device: rESWT
* Other: Supervised exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of LE was made in the clinical examination, and the diagnosis was confirmed with the Southampton Diagnostic Criteria of the presence of epicondyle pain, and epicondyle pain and tenderness on resisted extension of the wrist. Patients with symptoms lasting longer than 3 months with average pain in the previous week detected as 3 or above on a 10-cm visual analogue scale (VAS) who were aged over 18 years Exclusion Criteria: pain in the proximal part of the affected extremity (e.g. shoulder pain, neck pain) abnormal neurogenic symptoms (e.g. radicular pain, numbness) on the affected extremity presence of posterior interosseous nerve entrapment congenital or acquired upper extremity deformities that might affect grip strength systemic musculoskeletal system or neurologic disorders systemic rheumatologic disease or systemic infection presence of malignancy, coagulation disorders, and anticoagulant use inserted cardiac pacemaker history of surgical treatment on the elbow of the affected extremity pregnancy. patients who were administered other treatments such as physical therapy or steroid injections in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rESWT<br>the group receiving rESWT | Device: rESWT<br>* rESWT was administered once per week for 3 weeks using a ShockMaster 500 device with 1.8 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses.<br>|
| Active Comparator: supervised exercises<br>the group receiving supervised exercises | Other: Supervised exercises<br>* A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Patient-rated Tennis Elbow Evaluation score | The Patient-rated Tennis Elbow Evaluation is a specific questionnaire designed for the evaluation of the disease-specific pain and function/disability in LE. The scores were calculated separately and as the total PRTEE score, where 0 represented the best score, and 100 represented the worst score. The PRTEE consists of a pain scale with 5 items questioning pain during rest and specific activities (0 represents 'no pain' and 10 represents 'the highest pain'), and a function/disability scale with 10 items evaluating difficulties experienced during specific and daily activities (0 represents 'no difficulty' and 10 represents 'the highest difficulty) | Change from Baseline at 1 month and 3 months after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Visual Analogue Scale score | The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale | Change from Baseline at 1 month and 3 months after treatment. | 
| Change Roles and Maudsley Score | The Roles and Maudsley score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, no pain, complete movement, and complete activity; 2 points = good, discomfort from time to time, complete movement, and complete activity; 3 points = fair, discomfort after long-duration activity; and 4 points = poor, pain that restricts activity. | Change from Baseline at 1 month and 3 months after treatment. | 
| Change Grip Strength score | Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer | Change from Baseline at 1 month and 3 months after treatment. |