Acupuncture in Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325663
• Other study ID #: AKOK1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 12, 2006
• Last updated: May 12, 2006
• Start date: April 2004
• Est. completion date: April 2005

Study information

• Verified date: April 2004
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethikkomission der Medizinischen Fakultät Heidelberg
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Procedure:
• Acupuncture

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	The German Society for Traditional Chinese Medicine (DGTCM)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
Secondary	Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.