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Acupuncture in Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00325663
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : May 15, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis of the Knee Procedure: Acupuncture Phase 1 Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : April 2004
Estimated Study Completion Date : April 2005

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325663


Sponsors and Collaborators
Heidelberg University
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

ClinicalTrials.gov Identifier: NCT00325663     History of Changes
Other Study ID Numbers: AKOK1
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: May 15, 2006
Last Verified: April 2004

Keywords provided by Heidelberg University:
acupuncture
double-blind
sham control
osteoarthritis
pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases