Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis

Study Overview
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Brief Summary
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The aim of this study; to determine the effectiveness of ESWT, ultrasound and phonophoresis treatments on pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments to each other.

Detailed Description
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Lateral epicondylitis is the most common cause of elbow lateral pain in adults. Pain that occurs in LE and radiates to the humerus and forearm is characteristic of this disease. The main complaints being pain and decreased grip strength, both of which may affect activities of daily living. The patient's complaints regress with rest,but but can increase again during daily activities such as grasping, repetitive hand movements, holding door handles, turning keys, lifting heavy loads. Diagnosis of lateral epicondylitis is largely based on clinical history and examination. Conservative treatment is the first line treatment. Generally, %90 of patients with LE benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity modification, topical and oral NSAIDs, splinting, stretching and strengthening exercises, various injections, prolotherapy and electrotherapy modalities. Laser, TENS, ultrasound, phonophoresis, iontophoresis and ESWT are electrotherapeutic agents that can be used in therapy to relieve pain and promote healing. Research on physical treatments for LE has not yet proven superiority of one specific approach. Although many studies have been done for ESWT, ultrasound and phonophoresis, there is not any study that compares these three modalities.In addition, there ara fewer studies about measuring the effect of these treatment methods which contain control groups. In this study, our aim is to investigate the efficacy of ESWT, ultrasound therapy and phonophoresis methods used in the treatment of LE and to compare the efficacy of these three treatments against each other and control group.

Official Title
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Comparing the Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis: A Randomized Controlled Trial

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Device: ESWT
* Device: Phonophoresis
* Device: Ultrasound
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18-65 years Pain on the lateral side of the elbow for at least 4 weeks Tenderness over the lateral epicondyle Positive in at least two of the lateral epicondylitis spesific tests (Cozen test, Maudley test and Mills test) Exclusion Criteria: Be younger than 18 Having had ESWT treatment in the elbow area before History of injection, surgery, physical therapy in the elbow area in the last 3 months Previous elbow surgery History of radius/ulna fracture A history of cervical and shoulder problems having bilateral symptoms concomitant medial epicondylitis Malignancy Pregnancy Systemic rheumatologic disease or systemic infection inserted cardiac pacemaker presence of coagulation disorders Cognitive disfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: ESWT(Extracorporeal Shock Wave Therapy)<br>Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program | Device: ESWT<br>* Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises<br>|
| Experimental: Phonophoresis<br>Group 2 ( n=17) will be given five times a week, total 10 sessions of diclofenac phonophoresis + home exercise program | Device: Phonophoresis<br>* Group 2 ( n=17) will be given five times a week total 10 sessions of diclofenac phonophoresis + home exercise program Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises<br>|
| Experimental: Ultrasound therapy<br>Group 2 (n=17) will be given five times a week, total 10 sessions of ultrasound therapy+ home exercise program | Device: Ultrasound<br>* Group 3 (n=17) will be given five times a week total 10 sessions of ultrasound therapy+ home exercise program Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises<br>|
| Other: Control goup<br>Group 4 ( n=17) will be given home exercise program | Other: Control group<br>* Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | The self-evaluation of pain severity during rest, activity,night and with palpation was calculated using a 10-cm VAS scale | Change from Baseline at 1 month after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Rated Tennis Elbow Evaluation (PRTEE) scales | The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis | Change from Baseline at 1 month after treatment. | 
| Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score | The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness | Change from Baseline at 1 month after treatment. | 
| 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, 2 points = good, 3 points = fair and 4 points = poor. | Change from Baseline at 1 month after treatment. | 
| Health Assessment Questionnaire (HAQ) score | This is a self-reported questionnaire covering 20 items in eight domains related to measuring difficulty in performing activities of daily living: dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities | Change from Baseline at 1 month after treatment. | 
| Grip Strength score | Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer | Change from Baseline at 1 month after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lateral epicondylitis, extracorporeal shock wave therapy, ultrasound, phonophoresis