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

Not Applicable

Completed

• Conditions: Lateral Epicondylitis
• Interventions: Device: rESWT; Other: Supervised exercises

• Registration Number: NCT03834090
• Lead Sponsor: Istanbul University

Brief Summary

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

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

Study Timeline

• Study Start: 2015-02-20
• Primary Completion: 2015-08-15
• Study Completion: 2016-01-15
• Status Verified: 2019-02
• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-06
• Last Update Submitted: 2019-02-06
• Study First Posted: 2019-02-07
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rESWT	rESWT	the group receiving rESWT
supervised exercises	Supervised exercises	the group receiving supervised exercises

Primary Outcome Measures

Name	Time	Method
Change Patient-rated Tennis Elbow Evaluation score	Change from Baseline at 1 month and 3 months after treatment.	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)

Secondary Outcome Measures

Name	Time	Method
Change Visual Analogue Scale score	Change from Baseline at 1 month and 3 months after treatment.	The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale
Change Roles and Maudsley Score	Change from Baseline at 1 month and 3 months after treatment.	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 Grip Strength score	Change from Baseline at 1 month and 3 months after treatment.	Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer