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Leeches for the Treatment of ...

Leeches for the Treatment of Knee Osteoarthritis

Last Updated: 2007-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-12-31

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.

Detailed Description

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Conditions

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Osteoarthritis Arthralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Single Leeching

Intervention Type PROCEDURE

Repeated Leeching after 4 weeks

Intervention Type PROCEDURE

Placebo Leeching

Intervention Type PROCEDURE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Stefan Andereya, MD

Role: STUDY_CHAIR

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

Locations

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

Aachen, , Germany

Site Status

Countries

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Germany

References

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

Reference Type BACKGROUND

PMID: 15926663 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15145739 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12576043 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10949353 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 1524375 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 3190866 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16611201 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11173046 (View on PubMed)

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

Reference Type BACKGROUND

PMID: 15525954 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12233807 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14597456 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14597463 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8230645 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11824950 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9101520 (View on PubMed)

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. doi: 10.1016/s1063-4584(05)80101-3. No abstract available.

Reference Type BACKGROUND

PMID: 11048620 (View on PubMed)

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. doi: 10.2519/jospt.1998.28.2.88.

Reference Type BACKGROUND

PMID: 9699158 (View on PubMed)

Roos EM, Klassbo 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. doi: 10.1080/03009749950155562.

Reference Type BACKGROUND

PMID: 10503556 (View on PubMed)

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. doi: 10.1016/S0266-4356(03)00242-0.

Reference Type BACKGROUND

PMID: 15013545 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 3068365 (View on PubMed)

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. doi: 10.1055/s-0030-1248101.

Reference Type BACKGROUND

PMID: 16893154 (View on PubMed)

Englund M, Lohmander LS. Patellofemoral osteoarthritis coexistent with tibiofemoral osteoarthritis in a meniscectomy population. Ann Rheum Dis. 2005 Dec;64(12):1721-6. doi: 10.1136/ard.2005.035568. Epub 2005 Apr 20.

Reference Type BACKGROUND

PMID: 15843446 (View on PubMed)

Kessler S, Lang S, Puhl W, Stove 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. doi: 10.1055/s-2003-40083. German.

Reference Type BACKGROUND

PMID: 12822074 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 7112494 (View on PubMed)

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. doi: 10.1016/0049-3848(80)90314-x. No abstract available.

Reference Type BACKGROUND

PMID: 7376133 (View on PubMed)

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. doi: 10.1097/01.PCC.0000235422.23812.B4.

Reference Type BACKGROUND

PMID: 16878049 (View on PubMed)

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. doi: 10.1016/0098-2997(95)00002-x. No abstract available.

Reference Type BACKGROUND

PMID: 8569452 (View on PubMed)

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 Comp Pharmacol Toxicol. 1987;88(1):95-8. doi: 10.1016/0742-8413(87)90052-1.

Reference Type BACKGROUND

PMID: 2890494 (View on PubMed)

Scott K. Is hirudin a potential therapeutic agent for arthritis? Ann Rheum Dis. 2002 Jun;61(6):561-2. doi: 10.1136/ard.61.6.561. No abstract available.

Reference Type BACKGROUND

PMID: 12006337 (View on PubMed)

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. doi: 10.1515/bchm.1998.379.2.225.

Reference Type BACKGROUND

PMID: 9524076 (View on PubMed)

de Chalain TM. Exploring the use of the medicinal leech: a clinical risk-benefit analysis. J Reconstr Microsurg. 1996 Apr;12(3):165-72. doi: 10.1055/s-2007-1006471.

Reference Type BACKGROUND

PMID: 8726336 (View on PubMed)

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. doi: 10.1097/00000637-199209000-00008.

Reference Type BACKGROUND

PMID: 1524373 (View on PubMed)

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. doi: 10.1007/s100960050232. No abstract available.

Reference Type BACKGROUND

PMID: 10192721 (View on PubMed)

Ikizceli I, Avsarogullari L, Sozuer E, Yurumez Y, Akdur O. Bleeding due to a medicinal leech bite. Emerg Med J. 2005 Jun;22(6):458-60. doi: 10.1136/emj.2003.013847.

Reference Type BACKGROUND

PMID: 15911965 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EK 102/03

Identifier Type: -

Identifier Source: org_study_id

Leeches for the Treatment of Knee Osteoarthritis

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Interventions

Single Leeching

Repeated Leeching after 4 weeks

Placebo Leeching

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

University Hospital, Aachen

RWTH Aachen University

Principal Investigators

Stefan Andereya, MD

Locations

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

Countries

References

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

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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. doi: 10.2519/jospt.1998.28.2.88.

Roos EM, Klassbo 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. doi: 10.1080/03009749950155562.

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. doi: 10.1016/S0266-4356(03)00242-0.

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.

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. doi: 10.1055/s-0030-1248101.

Englund M, Lohmander LS. Patellofemoral osteoarthritis coexistent with tibiofemoral osteoarthritis in a meniscectomy population. Ann Rheum Dis. 2005 Dec;64(12):1721-6. doi: 10.1136/ard.2005.035568. Epub 2005 Apr 20.

Kessler S, Lang S, Puhl W, Stove 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. doi: 10.1055/s-2003-40083. German.

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.

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. doi: 10.1016/0049-3848(80)90314-x. No abstract available.

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. doi: 10.1097/01.PCC.0000235422.23812.B4.

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. doi: 10.1016/0098-2997(95)00002-x. No abstract available.

Scott K. Is hirudin a potential therapeutic agent for arthritis? Ann Rheum Dis. 2002 Jun;61(6):561-2. doi: 10.1136/ard.61.6.561. No abstract available.

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. doi: 10.1515/bchm.1998.379.2.225.

de Chalain TM. Exploring the use of the medicinal leech: a clinical risk-benefit analysis. J Reconstr Microsurg. 1996 Apr;12(3):165-72. doi: 10.1055/s-2007-1006471.

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. doi: 10.1097/00000637-199209000-00008.

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. doi: 10.1007/s100960050232. No abstract available.

Ikizceli I, Avsarogullari L, Sozuer E, Yurumez Y, Akdur O. Bleeding due to a medicinal leech bite. Emerg Med J. 2005 Jun;22(6):458-60. doi: 10.1136/emj.2003.013847.

Other Identifiers

EK 102/03