Leeches for the Treatment of Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Aachen
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00435773
First received: February 14, 2007
Last updated: April 6, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Arthralgia
Procedure: Single Leeching
Procedure: Repeated Leeching after 4 weeks
Procedure: Placebo Leeching
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Single and Repeated Leech Therapy for the Treatment of Late Stage Knee Osteoarthritis. A Randomized, Placebo Controlled Comparative Trial

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 118
Study Start Date: February 2004
Estimated Study Completion Date: December 2004
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435773

Locations
Germany
Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
University Hospital, Aachen
Investigators
Study Chair: Stefan Andereya, MD Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00435773     History of Changes
Other Study ID Numbers: EK 102/03
Study First Received: February 14, 2007
Last Updated: April 6, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by RWTH Aachen University:
Osteoarthritis
Leeching
Randomized Controlled Trial
Arthralgia

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthralgia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014