Acupuncture in Osteoarthritis of the Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Max Karner, MD

Role: PRINCIPAL_INVESTIGATOR

University Heidelberg

Johannes Greten, MD

Role: STUDY_DIRECTOR

German Society of Traditional Chinese Medicine

Oliver Gerlach, MD

Role: STUDY_CHAIR

Shen-Centre for Traditional Chinese Medicine, Erlangen, Germany

Frank Brazkiewicz, MD

Role: STUDY_CHAIR

Centre for Chinese Medicine, Bremen, Germany

Other Identifiers

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AKOK1

Identifier Type: -

Identifier Source: org_study_id