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OsteoarthritisPhase 2NCT00435773

Leeches for the Treatment of Knee Osteoarthritis

A Phase 2 study testing Single Leeching and Repeated Leeching after 4 weeks in people with Osteoarthritis and Arthralgia, run by RWTH Aachen University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteoarthritis, Arthralgia
What is being tested?
Single Leeching and Repeated Leeching after 4 weeks
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
1 siteGermany
Study dates
Feb 2004to Dec 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Aachen, 52074

Other trials in Germany

About this study

Official title: 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.

Being tested
Single Leeching, Repeated Leeching after 4 weeks, Placebo Leeching
Keywords
Osteoarthritis, Leeching, Randomized Controlled Trial, Arthralgia
Medical subject headings
Osteoarthritis, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single LeechingProcedure or surgery

  • Repeated Leeching after 4 weeksProcedure or surgery

  • Placebo LeechingProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months

  2. WOMAC Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months

  3. VAS (Visual analog scale, pain score)before intervention, after 1,4 and 6 weeks, 3 and 6 months

Secondary outcomes (4)

  1. KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months

  2. WOMAC subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months

  3. Requirement of pain medication before intervention, after 1,4 and 6 weeks, 3 and 6 months

  4. Adverse events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2007 (estimated)
  2. Study startFeb 2004
  3. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
118 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00435773
Sponsor's protocol ID
EK 102/03
Status last verified
Apr 2007
First submitted
14 Feb 2007
Last updated
9 Apr 2007
Results posted
No

Publications

  • Hyson JM. Leech therapy: a history. J Hist Dent. 2005 Mar;53(1):25-7.

    PubMed 15926663

  • Whitaker IS, Izadi D, Oliver DW, Monteath G, Butler PE. Hirudo Medicinalis and the plastic surgeon. Br J Plast Surg. 2004 Jun;57(4):348-53. doi: 10.1016/j.bjps.2003.12.016.

    PubMed 15145739

  • Rao J, Whitaker IS. Use of Hirudo medicinalis by maxillofacial surgical units in the United Kingdom: current views and practice. Br J Oral Maxillofac Surg. 2003 Feb;41(1):54-5. doi: 10.1016/s0266-4356(02)00284-x. No abstract available.

    PubMed 12576043

  • Weinfeld AB, Yuksel E, Boutros S, Gura DH, Akyurek M, Friedman JD. Clinical and scientific considerations in leech therapy for the management of acute venous congestion: an updated review. Ann Plast Surg. 2000 Aug;45(2):207-12. doi: 10.1097/00000637-200045020-00021.

    PubMed 10949353

  • Dabb RW, Malone JM, Leverett LC. The use of medicinal leeches in the salvage of flaps with venous congestion. Ann Plast Surg. 1992 Sep;29(3):250-6. doi: 10.1097/00000637-199209000-00010.

    PubMed 1524375

  • Hayden RE, Phillips JG, McLear PW. Leeches. Objective monitoring of altered perfusion in congested flaps. Arch Otolaryngol Head Neck Surg. 1988 Dec;114(12):1395-9. doi: 10.1001/archotol.1988.01860240045021.

    PubMed 3190866

  • Hernandez-Diaz S, Varas-Lorenzo C, Garcia Rodriguez LA. Non-steroidal antiinflammatory drugs and the risk of acute myocardial infarction. Basic Clin Pharmacol Toxicol. 2006 Mar;98(3):266-74. doi: 10.1111/j.1742-7843.2006.pto_302.x.

    PubMed 16611201

  • Hernandez-Diaz S, Garcia-Rodriguez LA. Epidemiologic assessment of the safety of conventional nonsteroidal anti-inflammatory drugs. Am J Med. 2001 Feb 19;110 Suppl 3A:20S-7S. doi: 10.1016/s0002-9343(00)00682-3.

    PubMed 11173046

  • Pilcher H. Medicinal leeches: stuck on you. Nature. 2004 Nov 4;432(7013):10-1. doi: 10.1038/432010a. No abstract available.

    PubMed 15525954

  • Michalsen A, Moebus S, Spahn G, Esch T, Langhorst J, Dobos GJ. Leech therapy for symptomatic treatment of knee osteoarthritis: results and implications of a pilot study. Altern Ther Health Med. 2002 Sep-Oct;8(5):84-8.

    PubMed 12233807

  • Michalsen A, Klotz S, Ludtke R, Moebus S, Spahn G, Dobos GJ. Effectiveness of leech therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2003 Nov 4;139(9):724-30. doi: 10.7326/0003-4819-139-9-200311040-00006.

    PubMed 14597456

  • Hochberg MC. Multidisciplinary integrative approach to treating knee pain in patients with osteoarthritis. Ann Intern Med. 2003 Nov 4;139(9):781-3. doi: 10.7326/0003-4819-139-9-200311040-00013. No abstract available.

    PubMed 14597463

  • Guyatt GH, Sackett DL, Cook DJ. Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 1993 Dec 1;270(21):2598-601. doi: 10.1001/jama.270.21.2598. No abstract available.

    PubMed 8230645

  • Wolfe F, Lane NE. The longterm outcome of osteoarthritis: rates and predictors of joint space narrowing in symptomatic patients with knee osteoarthritis. J Rheumatol. 2002 Jan;29(1):139-46.

    PubMed 11824950

  • Hochberg MC, Altman RD, Brandt KD, Moskowitz RW. Design and conduct of clinical trials in osteoarthritis: preliminary recommendations from a task force of the Osteoarthritis Research Society. J Rheumatol. 1997 Apr;24(4):792-4.

    PubMed 9101520

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Single Leeching and Repeated Leeching after 4 weeks in people with Osteoarthritis and Arthralgia, run by RWTH Aachen University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00435773, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2007; AzTrials last refreshed its copy on 7 Nov 2026.

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