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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000503-33-DE

Enrollment

Registered

2005-05-06

Start date

2005-09-02

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leeches 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).

Interventions

Trade Name: natural leech (Hirudo Medicinalis) Product Name: natural leech Pharmaceutical Form: Trade Name: Voltaren Emulgel Product Name: Voltaren Emulgel Pharmaceutical Form: Gel

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026