Acupuncture in Osteoarthritis of the Knee
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee|
- 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.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325663
|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|