Acupuncture in Osteoarthritis of the Knee

May 12, 2006 updated by: Heidelberg University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

125

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

May 15, 2006

Last Update Submitted That Met QC Criteria

May 12, 2006

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKOK1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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