Leeches for the Treatment of Knee Osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis; Arthralgia

• Registration Number: NCT00435773
• Lead Sponsor: RWTH Aachen University

Brief Summary

Previous studies have not addressed the question, whether or not a repeated leeching can supply symptomatic relief of osteoarthritic pain for extended periods of time. We present a randomized study to the effectiveness of single and repeated leech therapy in cases with advanced osteoarthritis of the knee using a large patient group compared to a control group, who were both blinded to the actual treatment modality.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study Completion: 2004-12
• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-15
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-06
• Last Update Posted: 2007-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Osteoarthritis of the knee
• Persistent osteoarthritic symptoms for at least 6 months
• Radiographic evidence of late stage osteoarthritis of the knee (stage III-IV)
• History of conservative management including pain medication and physical therapy

Exclusion Criteria

• Anticoagulant treatment or history of hemophilia
• History or presence of rheumatic diseases leading to secondary osteoarthritis
• Presence of hematological, hepatic, renal or immunological disease
• Insulin-dependant diabetes mellitus
• Intraarticular injections or systemic application of corticosteroids during the 3 preceding months
• History of surgery of the affected knee during the last 3 months or joint replacement
• History of previous leech therapy
• Lack of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
WOMAC Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
VAS (Visual analog scale, pain score)before intervention, after 1,4 and 6 weeks, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
WOMAC subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
Requirement of pain medication before intervention, after 1,4 and 6 weeks, 3 and 6 months
Adverse events

Trial Locations

Locations (1)

Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany; 🇩🇪 Aachen, Germany