Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint

Not Applicable

Terminated

• Conditions: Rhizarthrosis
• Interventions: Biological: Leeches; Drug: Diclofenac

• Registration Number: NCT03020368
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

In this trial the investigators want to prove the efficacy and safety of a one-time topical leech application at patients with symptomatic primary arthrosis of the first carpometacarpal joint in comparison to the standard therapy with topical diclofenac.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Male and female patients aged 35 to 85 years
• Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0 to 100 mm (relative to the last 24 hours)
• Complaints for at least 3 months
• X-ray Stadium Eaton I-IV at least once secured

Exclusion Criteria

• Anticoagulation (Marcumar, Heparin)
• Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies
• Combination therapy of ASA and thienopyridines
• Pain medication with opioid analgesics
• Systemic medication with corticoids or immunosuppressants
• Intraarterticular injections or RSO within the last 3 months
• Past or planned surgery on the affected joint in the next 2 months
• Pregnancy, lactation
• Insulin-dependent type I diabetes mellitus
• Acute psychotic disorders
• Severe comorbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leeches	Leeches	One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base
Diclofenac	Diclofenac	3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder and Hand (DASH)	Change after 28 and 56 days

Secondary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	Change after 7, 28 and 56 days
Medication on demand	Documentation between baseline and day 56	Documentation in daily diary

Trial Locations

Locations (1)

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus; 🇩🇪 Berlin, Germany