Acupuncture in Osteoarthritis of the Knee

Phase 1

Completed

• Conditions: Osteoarthritis of the Knee

• Registration Number: NCT00325663
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Status Verified: 2004-04
• Study Start: 2004-04
• Study Completion: 2005-04
• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Last Update Submitted: 2006-05-12
• Study First Posted: 2006-05-15
• Last Update Posted: 2006-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

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