Leeches for the Treatment of Knee Osteoarthritis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00435773

Enrollment

118

Registered

2007-02-15

Start date

2004-02-29

Completion date

2004-12-31

Last updated

2007-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthralgia, Osteoarthritis

Keywords

Osteoarthritis, Leeching, Randomized Controlled Trial, Arthralgia

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.

Interventions

PROCEDURESingle Leeching

PROCEDURERepeated Leeching after 4 weeks

PROCEDUREPlacebo Leeching

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	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

Measure	Time frame
KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months	—
Adverse events	—
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026