Acupuncture in Osteoarthritis of the Knee - Full Text View

Sponsors and Collaborators:	University of Heidelberg The German Society for Traditional Chinese Medicine (DGTCM)
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00325663

Purpose

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
Osteoarthritis of the Knee	Procedure: Acupuncture	Phase I Phase II

MedlinePlus related topics: Acupuncture Osteoarthritis

U.S. FDA Resources

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

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.

Secondary Outcome Measures:

Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.

Estimated Enrollment:	125
Study Start Date:	April 2004
Estimated Study Completion Date:	April 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	35 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325663

Sponsors and Collaborators

University of Heidelberg

The German Society for Traditional Chinese Medicine (DGTCM)

Investigators

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

More Information

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

Keywords provided by University of Heidelberg:

acupuncture
double-blind
sham control
osteoarthritis
pain

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Pain
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009