Acupuncture in Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Collaborator:
The German Society for Traditional Chinese Medicine (DGTCM)
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00325663
First received: May 12, 2006
Last updated: NA
Last verified: April 2004
History: No changes posted

May 12, 2006
May 12, 2006
April 2004
Not Provided
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
Same as current
No Changes Posted
Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
Same as current
Not Provided
Not Provided
 
Acupuncture in Osteoarthritis of the Knee
Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee

The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis of the Knee
Procedure: Acupuncture
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
April 2005
Not Provided

Inclusion Criteria:

  • Patients above age 35
  • knee osteoarthritis grade II or III according to the Kellgren classification.

Exclusion Criteria:

  • orthopedic deformations of the knee,
  • malignant disease
  • auto-immune disorders
  • surgery including arthroscopy during the past 12 months
  • pain medication with steroids
  • physical therapy or acupuncture within the last for weeks
  • no or a pain medication in continuous dosage
Both
35 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00325663
AKOK1
Not Provided
Not Provided
Heidelberg University
The German Society for Traditional Chinese Medicine (DGTCM)
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
Heidelberg University
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP