Sponsor: Haydarpasa Numune Training and Research Hospital
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Overview
This randomized single-blind controlled trial aims to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Sixty participants aged 18-65 years will be randomized into two groups. The dry needling group will receive ultrasound-guided tendon fenestration once weekly for five sessions, while the ESWT group will receive radial extracorporeal shock wave therapy once weekly for five sessions. All participants will be given a standardized home exercise program. Pain, function, grip strength, pressure pain threshold, quality of life, and ultrasonographic findings will be evaluated at baseline, post-treatment, and at 3- and 6-month follow-up. The primary outcome is change in pain severity measured by Visual Analog Scale.
Description
This prospective, randomized, parallel-group, single-blind clinical trial is designed to compare the effectiveness of ultrasound-guided dry needling and extracorporeal shock wave therapy in patients with lateral epicondylitis. Participants aged 18-65 years with symptoms lasting at least six weeks will be randomly assigned in a 1:1 ratio using computer-generated block randomization with sealed opaque envelopes. Due to the nature of the interventions, participants and treating physicians will not be blinded; however, all clinical and ultrasonographic assessments will be performed by an investigator blinded to treatment allocation.
Participants in the dry needling group will receive ultrasound-guided tendon fenestration targeting the pathologic area of the common extensor tendon. The procedure will be performed once weekly for five sessions. Participants in the ESWT group will receive radial extracorporeal shock wave therapy applied to the most tender point over the lateral epicondyle using standard treatment parameters. ESWT will also be administered once weekly for five sessions.
All participants will receive a standardized home exercise program consisting of eccentric strengthening and stretching exercises for the wrist extensors. Assessments will be performed at baseline, immediately after treatment, and at 3- and 6-month follow-up visits. Outcome measures will include pain intensity, functional status, grip strength, pressure pain threshold, quality of life, and ultrasonographic tendon characteristics including grayscale and Power Doppler findings.
Who can participate
Inclusion Criteria:
* Adults aged 18 to 65 years
* Clinical diagnosis of lateral epicondylitis
* Symptoms persisting for at least 6 weeks
* Pain over the lateral epicondyle aggravated by wrist extension or gripping activities
* Positive provocative tests consistent with lateral epicondylitis (e.g., Cozen's test and/or Mill's test)
* Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
* Previous surgery for lateral epicondylitis in the affected elbow
* Corticosteroid injection, PRP injection, prolotherapy, mesotherapy, or ESWT to the affected elbow within the previous 6 months
* Bilateral lateral epicondylitis requiring simultaneous treatment
* Cervical radiculopathy or other neurologic disorders affecting the upper extremity
* Inflammatory rheumatic disease
* Elbow osteoarthritis or significant structural elbow pathology
* Full-thickness tendon tear or other major tendon injury on imaging
* Pregnancy or breastfeeding
* Active infection, skin lesion, or wound at the treatment site
* Use of anticoagulant therapy or bleeding disorder
* Inability to comply with follow-up assessments