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

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

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

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Device: rESWT; Other: Supervised exercises

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rESWT; the group receiving rESWT	Device: rESWT; 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.
Active Comparator: supervised exercises; the group receiving supervised exercises	Other: Supervised exercises; A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2015
• Primary Completion (Actual): August 15, 2015
• Study Completion (Actual): January 15, 2016

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 2015/369

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No