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NCT Number: NCT00435773

Leeches for the Treatment of Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Arthralgia Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany

Aachen, 52074, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Leeching

Procedure

Repeated Leeching after 4 weeks

Procedure

Placebo Leeching

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • University Hospital, Aachen

Registry information

Official study title

Single and Repeated Leech Therapy for the Treatment of Late Stage Knee Osteoarthritis. A Randomized, Placebo Controlled Comparative Trial

Important dates

Study start
2004
Study completion
2004
First posted
Feb 15, 2007
Registry last updated
Apr 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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