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

NCT03834090 | Completed

• 1 other identifier: 2015/369
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change Visual Analogue Scale score

  Change from Baseline at 1 month and 3 months after treatment.

• Change Roles and Maudsley Score

  Change from Baseline at 1 month and 3 months after treatment.

• Change Grip Strength score

  Change from Baseline at 1 month and 3 months after treatment.

Study Arms (2)

rESWT

EXPERIMENTAL

the group receiving rESWT

Device: rESWT

supervised exercises

ACTIVE COMPARATOR

the group receiving supervised exercises

Other: Supervised exercises

Interventions

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.

rESWT

Supervised exercises OTHER

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

supervised exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: February 20, 2015
• Primary Completion: August 15, 2015
• Study Completion: January 15, 2016
• Last Updated: February 7, 2019

Record last verified: 2019-02