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Leeches for the Treatment of Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00435773
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : April 9, 2007
Sponsor:
Collaborator:
University Hospital, Aachen
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthralgia Procedure: Single Leeching Procedure: Repeated Leeching after 4 weeks Procedure: Placebo Leeching Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Single and Repeated Leech Therapy for the Treatment of Late Stage Knee Osteoarthritis. A Randomized, Placebo Controlled Comparative Trial
Study Start Date : February 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources




Primary Outcome Measures :
  1. KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
  2. WOMAC Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
  3. VAS (Visual analog scale, pain score)before intervention, after 1,4 and 6 weeks, 3 and 6 months

Secondary Outcome Measures :
  1. KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
  2. WOMAC subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
  3. Requirement of pain medication before intervention, after 1,4 and 6 weeks, 3 and 6 months
  4. Adverse events


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

ClinicalTrials.gov Identifier: NCT00435773     History of Changes
Other Study ID Numbers: EK 102/03
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: April 9, 2007
Last Verified: April 2007

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
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms