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Sponsors and Collaborators: |
University of Heidelberg The German Society for Traditional Chinese Medicine (DGTCM) |
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Information provided by: | University of Heidelberg |
ClinicalTrials.gov Identifier: | NCT00325663 |
The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee
Condition | Intervention | Phase |
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Osteoarthritis of the Knee |
Procedure: Acupuncture |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee |
Estimated Enrollment: | 125 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | April 2005 |
Background: Acupuncture is one of the most frequently used complementary therapeutic approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings of previous randomized controlled studies, controversy persists whether the observed effects are specific to acupuncture or non-specific consequences of needling.
Objective: To compare classical Chinese acupuncture, semi-standardized modern acupuncture and non-specific needling by means of a double-blinded repeated measures cross-over design.
Intervention: Within three weeks all patients receive three treatment modalities in a random order in a double-blind study design.
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
Ages Eligible for Study: | 35 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Max Karner, MD | University Heidelberg |
Study Director: | Johannes Greten, MD | German Society of Traditional Chinese Medicine |
Study Chair: | Oliver Gerlach, MD | Shen-Centre for Traditional Chinese Medicine, Erlangen, Germany |
Study Chair: | Frank Brazkiewicz, MD | Centre for Chinese Medicine, Bremen, Germany |
Study ID Numbers: | AKOK1 |
Study First Received: | May 12, 2006 |
Last Updated: | May 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00325663 |
Health Authority: | Germany: Ethikkomission der Medizinischen Fakultät Heidelberg |
acupuncture double-blind sham control osteoarthritis pain |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |