Leeches for the Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Arthralgia

Intervention / Treatment
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* Procedure: Single Leeching
* Procedure: Repeated Leeching after 4 weeks
* Procedure: Placebo Leeching


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Single Leeching|nan|
|Procedure: Repeated Leeching after 4 weeks|nan|
|Procedure: Placebo Leeching|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Leeching, Randomized Controlled Trial, Arthralgia