Skip to main content
OpenTrials
Completed

NCT Number: NCT03834090

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RESWT

Device

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.

Supervised exercises

Other

A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors

Primary outcomes

  1. Change Patient-rated Tennis Elbow Evaluation score

    Time frame: 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 outcomes

  1. Change Visual Analogue Scale score

    Time frame: 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

  2. Change Roles and Maudsley Score

    Time frame: 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".

  3. Change Grip Strength score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 7, 2019
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.