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

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834090
• Other study ID #: 2015/369
• Status: Completed
• Phase: N/A
• Start date: February 20, 2015
• Est. completion date: January 15, 2016

Study information

• Verified date: February 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 15, 2016
• Est. primary completion date: August 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.