Clinical trial NCT00435773: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Arthralgia
Keywords: Osteoarthritis
Leeching
Randomized Controlled Trial
Arthralgia
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: University Hospital, Aachen
First posted: 2007-02-15
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
measure: WOMAC Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
measure: VAS (Visual analog scale, pain score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
Secondary outcomes:
measure: KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
measure: WOMAC subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
measure: Requirement of pain medication before intervention, after 1,4 and 6 weeks, 3 and 6 months
measure: Adverse events
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany
Study officials:
affiliation: Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany
name: Stefan Andereya, MD
role: STUDY_CHAIR
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