Prospective randomized study of the effect of autologous concentrated thrombocytes versus corticosteroid injections in lateral epicondylitis.

Phase 4

Withdrawn

• Conditions: lateral epicondylitis; tennis elbow; 10043237

• Registration Number: NL-OMON29929
• Lead Sponsor: Ortomed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

-Men and women with lateral epicondylitis > 3 months
-Pain with palpation of the lateral epicondyl
-Pain not responding to wearing a brace or manual therapy

Exclusion Criteria

-Deformities of the elbow, arthrosis, previous surgery or trauma of the elbow confirmed by X-ray(AP,lateral).
-Surgical treatment or corticosteroidinjections for lateral epicondylitis in last 6 months.
-Cervical radiculopathy or carpal tunnel syndrome in medical history.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Each patient randomly assigned to a treatment and with at least one non-missing<br /><br>pre- and post-baseline measurement, will be classified at each visit, as either<br /><br>a treatment success or failure. Patients with a painscore reduction of >25%<br /><br>compared to baseline, did not require pain medication beyond the protocol<br /><br>defined allowable amount, and did not require escape therapy will be considered<br /><br>a treatment success.<br /><br><br /><br>The absolute change from baseline to endpoint means the baseline value is<br /><br>subtracted from the endpoint value. Percent change is defined as the absolute<br /><br>change multiplied by 100 divided by the baseline value. For patients whose pain<br /><br>improves, these values will be less than zero. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>