Leeches for the Treatment of Knee Osteoarthritis

April 6, 2007 updated by: RWTH Aachen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Adverse events
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

University Hospital, Aachen

Investigators

  • Study Chair: Stefan Andereya, MD, Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (ESTIMATE)

February 15, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2007

Last Update Submitted That Met QC Criteria

April 6, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 102/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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