Open Access Study protocol

Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial

Seunghoon Lee12, Joo-Hee Kim12, Kyung-Min Shin1, Jung-Eun Kim1, Tae-Hun Kim3, Kyung-Won Kang1, Minhee Lee1, So-Young Jung1, Mi-Suk Shin1, Ae-Ran Kim1, Hyo-Ju Park1, Kwon-Eui Hong4 and Sun-Mi Choi1*

Author Affiliations

1 Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine, Daejeon, Korea

2 Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Korea

3 Mokhuri Neck and Back Hospital, Seoul, Korea

4 Department of Acupuncture & Moxibustion, College of Korean Medicine, Daejeon University, Daejeon, Korea

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Trials 2013, 14:225  doi:10.1186/1745-6215-14-225

Published: 18 July 2013

Abstract

Background

The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research.

Methods/design

This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit.

Discussion

The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN.

Trial registration

Clinical Research information Service. Unique identifier: KCT0000466.

Keywords:
Electroacupuncture; Painful diabetic neuropathy; Protocol