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

Phase 4

Completed

• Conditions: lateral epicondylitis; tenniselbow; 10028377

• Registration Number: NL-OMON30936
• Lead Sponsor: BioMet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

-Men and women with lateral epicondylitis > 6 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<br /><br>non-missing pre- and postbasdeline measurement, wiuoll be classified at each<br /><br>visit, as either succes or failure. Patients with a painscore reducytion>25 %<br /><br>cpmpared to the baseline, did not require pain medication beyond protocol<br /><br>defined allowable amount, and did not require escape therapy will be considerd<br /><br>a treatment succes.<br /><br><br /><br>The absolute change from baseline to endpoint means the baseline value is<br /><br>substracted from the endpoint value.Percent change is defined as the absolute<br /><br>change multiplied by 100 divided by the baseline value.<br /><br>For patients whose pain improves, these values will be less than zero. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.v.t.</p><br>