Effectiveness of leech therapy in epicondylitis humeroradialis - a randomized controlled trial - leeches in epicondylitis

• Conditions: In the planned study patients with painful epicondylitis humeroradialis of the ellbow are treated with leeches or a standard treatment.

• Registration Number: EUCTR2005-000893-27-DE
• Lead Sponsor: Prof. Gustav Dobos, Kliniken Essen Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Diagnosis of Epicondylitis
- pain on more than 50% of the days in the last month
- age 20-75 years old
- informed consent
- no planned treatment or operation within the next 3 month

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- other causes of ellbow pain than epicondylitis humeroradialis
- steroid injection within the last 3 weeks
- hemophilia or othe bleeding disorders
- medication with marumar, warfarin, heparin or heparinoids
- anemia
- renal failure
- severe other comorbidity
- pregnancy
- psychosis
- dementia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Background: Leeches therapy has been proven to be successful in the treatment of knee osteoarthritis. Its effects in epicondylitis is unknown.<br><br>Main objective: To evaluate the symptomatic effects of a single leech therapy versus topical adminstration of diclofenac at epicondylitis humeroradialis. Main outomce parameter is assessed by Visual Analogue scale for pain at one week after the intervention.;Secondary Objective: To assess the improvement of Joint function (DASH-Questionaire), related qualitiy of life (SF 36) and isometric strength of the hand extensors.;Primary end point(s): Pain reduction on self rated VAS sum-score at day 7 after the intervetion compared to baseline.