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Leeches for the Treatment of Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Arthralgia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Single Leeching
Repeated Leeching after 4 weeks
Placebo Leeching
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Leeching, Randomized Controlled Trial, Arthralgia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

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

Full Information

First Posted
February 14, 2007
Last Updated
April 6, 2007
Sponsor
RWTH Aachen University
Collaborators
University Hospital, Aachen
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1. Study Identification

Unique Protocol Identification Number
NCT00435773
Brief Title
Leeches for the Treatment of Knee Osteoarthritis
Official Title
Single and Repeated Leech Therapy for the Treatment of Late Stage Knee Osteoarthritis. A Randomized, Placebo Controlled Comparative Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
RWTH Aachen University
Collaborators
University Hospital, Aachen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Arthralgia
Keywords
Osteoarthritis, Leeching, Randomized Controlled Trial, Arthralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
118 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Single Leeching
Intervention Type
Procedure
Intervention Name(s)
Repeated Leeching after 4 weeks
Intervention Type
Procedure
Intervention Name(s)
Placebo Leeching
Primary Outcome Measure Information:
Title
KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
Title
WOMAC Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
Title
VAS (Visual analog scale, pain score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
Secondary Outcome Measure Information:
Title
KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
Title
WOMAC subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
Title
Requirement of pain medication before intervention, after 1,4 and 6 weeks, 3 and 6 months
Title
Adverse events

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Andereya, MD
Organizational Affiliation
Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Leeches for the Treatment of Knee Osteoarthritis

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