Leeches for the Treatment of Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435773
• Other study ID #: EK 102/03
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2007
• Last updated: April 6, 2007
• Start date: February 2004
• Est. completion date: December 2004

Study information

• Verified date: April 2007
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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 patient group compared to a control group, who were both blinded to the actual treatment modality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthralgia
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Single Leeching

• Repeated Leeching after 4 weeks

• Placebo Leeching

Locations

Country	Name	City	State
Germany	Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany	Aachen

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	University Hospital, Aachen

Country where clinical trial is conducted

Germany, 

References & Publications (34)

Altman R, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA, Buckwalter J, Dougados M, Ehrlich G, Lequesne M, Lohmander S, Murphy WA Jr, Rosario-Jansen T, Schwartz B, Trippel S. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop. Osteoarthritis Cartilage. 1996 Dec;4(4):217-43. — View Citation

Ascenzi P, Amiconi G, Bode W, Bolognesi M, Coletta M, Menegatti E. Proteinase inhibitors from the European medicinal leech Hirudo medicinalis: structural, functional and biomedical aspects. Mol Aspects Med. 1995;16(3):215-313. Review. — View Citation

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40. — View Citation

Brown JE, Baugh RF, Hougie C. The inhibition of the intrinsic generation of activated factor X by heparin and hirudin. Thromb Res. 1980 Jan 1-15;17(1-2):267-72. — View Citation

Bush D, Fritz H, Knight C, Mount J, Scott K. A hirudin-sensitive, growth-related proteinase from human fibroblasts. Biol Chem. 1998 Feb;379(2):225-9. — View Citation

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. — View Citation

de Chalain TM. Exploring the use of the medicinal leech: a clinical risk-benefit analysis. J Reconstr Microsurg. 1996 Apr;12(3):165-72. — View Citation

Dippenaar R, Smith J, Goussard P, Walters E. Meningococcal purpura fulminans treated with medicinal leeches. Pediatr Crit Care Med. 2006 Sep;7(5):476-8. — View Citation

Englund M, Lohmander LS. Patellofemoral osteoarthritis coexistent with tibiofemoral osteoarthritis in a meniscectomy population. Ann Rheum Dis. 2005 Dec;64(12):1721-6. Epub 2005 Apr 20. — View Citation

Fenollar F, Fournier PE, Legre R. Unusual case of Aeromonas sobria cellulitis associated with the use of leeches. Eur J Clin Microbiol Infect Dis. 1999 Jan;18(1):72-3. — View Citation

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. — View Citation

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. — View Citation

Hernández-Díaz S, García-Rodríguez LA. Epidemiologic assessment of the safety of conventional nonsteroidal anti-inflammatory drugs. Am J Med. 2001 Feb 19;110 Suppl 3A:20S-7S. Review. — View Citation

Hernández-Díaz S, Varas-Lorenzo C, García Rodríguez LA. Non-steroidal antiinflammatory drugs and the risk of acute myocardial infarction. Basic Clin Pharmacol Toxicol. 2006 Mar;98(3):266-74. — View Citation

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. — View Citation

Hochberg MC. Multidisciplinary integrative approach to treating knee pain in patients with osteoarthritis. Ann Intern Med. 2003 Nov 4;139(9):781-3. — View Citation

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

Ikizceli I, Avsarogullari L, Sözüer E, Yürümez Y, Akdur O. Bleeding due to a medicinal leech bite. Emerg Med J. 2005 Jun;22(6):458-60. — View Citation

Kessler S, Lang S, Puhl W, Stöve J. [The Knee Injury and Osteoarthritis Outcome Score--a multifunctional questionnaire to measure outcome in knee arthroplasty]. Z Orthop Ihre Grenzgeb. 2003 May-Jun;141(3):277-82. German. — View Citation

Lahav A, Burks RT, Greis PE, Chapman AW, Ford GM, Fink BP. Clinical outcomes following osteochondral autologous transplantation (OATS). J Knee Surg. 2006 Jul;19(3):169-73. — View Citation

Lineaweaver WC, Hill MK, Buncke GM, Follansbee S, Buncke HJ, Wong RK, Manders EK, Grotting JC, Anthony J, Mathes SJ. Aeromonas hydrophila infections following use of medicinal leeches in replantation and flap surgery. Ann Plast Surg. 1992 Sep;29(3):238-44. Review. — View Citation

Markwardt F, Hauptmann J, Nowak G, Klessen C, Walsmann P. Pharmacological studies on the antithrombotic action of hirudin in experimental animals. Thromb Haemost. 1982 Jun 28;47(3):226-9. — View Citation

Michalsen A, Klotz S, Lüdtke 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. — View Citation

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. — View Citation

Pilcher H. Medicinal leeches: stuck on you. Nature. 2004 Nov 4;432(7013):10-1. — View Citation

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. — View Citation

Rigbi M, Levy H, Eldor A, Iraqi F, Teitelbaum M, Orevi M, Horovitz A, Galun R. The saliva of the medicinal leech Hirudo medicinalis--II. Inhibition of platelet aggregation and of leukocyte activity and examination of reputed anaesthetic effects. Comp Biochem Physiol C. 1987;88(1):95-8. — View Citation

Roos EM, Klässbo M, Lohmander LS. WOMAC osteoarthritis index. Reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Western Ontario and MacMaster Universities. Scand J Rheumatol. 1999;28(4):210-5. — View Citation

Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. — View Citation

Scott K. Is hirudin a potential therapeutic agent for arthritis? Ann Rheum Dis. 2002 Jun;61(6):561-2. — View Citation

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. Review. — View Citation

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. — View Citation

Whitaker IS, Rao J, Izadi D, Butler PE. Historical Article: Hirudo medicinalis: ancient origins of, and trends in the use of medicinal leeches throughout history. Br J Oral Maxillofac Surg. 2004 Apr;42(2):133-7. — View Citation

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. — View Citation

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
Primary	WOMAC Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
Primary	VAS (Visual analog scale, pain score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
Secondary	KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
Secondary	WOMAC subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
Secondary	Requirement of pain medication before intervention, after 1,4 and 6 weeks, 3 and 6 months
Secondary	Adverse events