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

NCT ID: NCT03834090

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-20
• Study Completion Date: 2016-01-15

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

Conditions

Lateral Epicondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rESWT

the group receiving rESWT

Group Type: EXPERIMENTAL

rESWT

Intervention Type: 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

the group receiving supervised exercises

Group Type: ACTIVE_COMPARATOR

Supervised exercises

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Supervised exercises

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

MUSTAFA CORUM

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2015/369

Identifier Type: -

Identifier Source: org_study_id