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Acupuncture in Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring acupuncture, double-blind, sham control, osteoarthritis, pain

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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.

Full Information

NCT ID

NCT00325663

First Posted

May 12, 2006

Last Updated

May 12, 2006

Sponsor

Heidelberg University

Collaborators

The German Society for Traditional Chinese Medicine (DGTCM)

1. Study Identification

Unique Protocol Identification Number

NCT00325663

Brief Title

Acupuncture in Osteoarthritis of the Knee

Official Title

Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee

Study Type

Interventional

2. Study Status

Record Verification Date

April 2004

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

Collaborators

The German Society for Traditional Chinese Medicine (DGTCM)

4. Oversight

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

acupuncture, double-blind, sham control, osteoarthritis, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

125 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Acupuncture

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Max Karner, MD

Organizational Affiliation

University Heidelberg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Johannes Greten, MD

Organizational Affiliation

German Society of Traditional Chinese Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Oliver Gerlach, MD

Organizational Affiliation

Shen-Centre for Traditional Chinese Medicine, Erlangen, Germany

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Frank Brazkiewicz, MD

Organizational Affiliation

Centre for Chinese Medicine, Bremen, Germany

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Acupuncture in Osteoarthritis of the Knee

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