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Open Access Study protocol

Comparing the effects of individualized, standard, sham and no acupuncture in the treatment of knee osteoarthritis: a multicenter randomized controlled trial

Eun-Jung Kim1, Chi-Yeon Lim2, Eun-Yong Lee3, Seung-Deok Lee1 and Kap-Sung Kim14*

Author Affiliations

1 College of Korean Medicine, Dongguk University, Gyeongju, South Korea

2 Department of Medicine, Dongguk University, Gyeongju, South Korea

3 College of Oriental(Korean) Medicine, Semyung University, Chung-ju, South Korea

4 Department of Acupuncture and Moxibustion, Dongguk University International Hospital, Siksa-dong, Ilsandong-gu, Goyang, Gyeonggi-do, South Korea

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Trials 2013, 14:129  doi:10.1186/1745-6215-14-129

Published: 7 May 2013

Abstract

Background

Acupuncture is an effective yet complex therapy, integrating syndrome differentiation, selection of appropriate acupoints and skillful needling techniques. Clinicians carefully tailor acupuncture treatment to each patient. However, most clinical trials of acupuncture have been based on a standardized formula of points for every patient without properly accounting for individualdifferences and, as a result, have not been reflective of the true efficacy of clinical practice. To determine the efficacy of meridian-based syndrome differentiation and Sa-am acupuncture, we have designed a simple pragmatic trial providing individualized treatments while working within a general framework.

Methods/Design

The study is designed to be a parallel, patient- and assessor-blind, randomized controlled trial (RCT). A total of250 patients with knee osteoarthritis (OA) will be recruited from two independent hospitals, Semyung University Oriental Medicine Hospital in Chung-ju and Dongguk University Oriental Hospital in Ilsan, South Korea. Patients will be randomly allocated into four treatment groups: 1. individualized, meridian-based syndrome differentiation and Sa-am acupuncture treatment;2. standard acupuncture treatment;3. sham acupuncture treatment; and 4. no acupuncture treatment. Patients in groups 1 to 3 will be treated by certified oriental medicine doctors twice a week for 6 weeks. The primary outcome measure will be the self-reported total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change. The trial will also include secondary outcome measures.

Discussion

This trial is designed to determine the efficacy of individualized acupuncture treatment in patients with knee OA by comparing the differences between individualized, standard, sham and no acupuncture treatments. The results of this trial may validate the efficacy of individualized acupuncture therapy, encouraging its widespread use.

Trial registration

ClinicalTrials.gov: NCT01569230

Keywords:
Acupuncture; Syndrome differentiation; Sa-am acupuncture; Individualized treatment; Knee osteoarthritis; RCT