Effectiveness of leech therapy in osteoarthritis of the thumb joint (rhizarthrosis) - a randomized controlled trial - leeches in rhizarthrosis

Conditions: eeches therapy has been successully evaluated in symptomatic knee osteoarthrits for pain relief. In the planned study patients with painful rhizarthrosis (arthrosis of the thumb joint) will be recruited and treated with once topical leeches therapy or over 4 weeks with an established topical analgetic standard treatment (topical diclofenac gel).

Registration Number: EUCTR2005-000503-33-DE

Lead Sponsor: Department Integrative Medicine, Kliniken Essen Mitte

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 32

Inclusion Criteria

-Established Rhizarthrosis
-Pain on more than 50% of days in the last 3 months
-Pain severity on VAS (0-10) > 4.
-Patients 40 to 85 years old
-Informed consent
-No planned local treatment or operation within the next 3 months
-no intraarticular injections within the last 3 months
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

-known hemophilia or bleeding disorder in history
-medication with marcumar, 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: To evaluate the symptomatic effect of a single leech therapy versus topical diclofenac on pain reduction of the basal thumb joint, assessed by Visual Analogue scale, at one week and two months after the intervention (single leech therapy or daily topical diclofenac) ;Secondary Objective: To assess the impact on joint function (DASH- questionnaire) and related quality of life (SF-36) and joint vigor (Vigorimetry);Primary end point(s): Pain reduction on self-rated VAS at day 7 after the intervention<br>

Secondary Outcome Measures