Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial

<p>Abstract</p> <p>Background</p> <p>Use of acupuncture has widely increased in patients with chronic low back pain. However, the evidence supporting its efficacy remains unclear. In this article, we report the design and the protocol of a multi-center randomized sham-c...

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Main Authors: Shin Im, Lee Hyangsook, Park Hi-Joon, Lee Jun-Hwan, Song Mi-Yeon
Format: Article
Language:English
Published: BMC 2010-06-01
Series:BMC Musculoskeletal Disorders
Online Access:http://www.biomedcentral.com/1471-2474/11/118
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author Shin Im
Lee Hyangsook
Park Hi-Joon
Lee Jun-Hwan
Song Mi-Yeon
author_facet Shin Im
Lee Hyangsook
Park Hi-Joon
Lee Jun-Hwan
Song Mi-Yeon
author_sort Shin Im
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Use of acupuncture has widely increased in patients with chronic low back pain. However, the evidence supporting its efficacy remains unclear. In this article, we report the design and the protocol of a multi-center randomized sham-controlled trial to treat chronic low back pain. Our goal is to verify the effect of acupuncture on chronic low back pain.</p> <p>Methods/Design</p> <p>This study is a multi-center randomized sham-controlled trial with 2 parallel arms. Participants included in the study met the following criteria: 1) low back pain lasting for at least the last 3 months, 2) a documented ≥ 5 points on a 10 cm visual analog scale for bothersomeness of low back pain at the time of screening and 3) between 18 and 65 years of age. Participants were blinded to the real and sham acupuncture treatments. The real acupuncture treatment group received real acupuncture 2 times a week, during a total of 12 sessions over 6 weeks. The control group received sham acupuncture during the same period. In order to assess the primary and secondary outcome measures, the participants were asked to fill out a questionnaire at the baseline and 6, 8, 12 and 24 weeks after starting the treatments. The primary outcome was measured using the visual analog scale for bothersomeness of low back pain at 8 weeks after the initiation of treatments.</p> <p>Discussion</p> <p>The result of this trial (which will be available in 2010) will demonstrate the efficacy of using acupuncture to treat chronic low back pain.</p> <p>Trial registration</p> <p>This study is registered with the U.S. National Institutes of Health Clinical Trials registry: NCT00815529</p>
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spelling doaj.art-44a441845bbf4c27afb865e61ad774192022-12-22T03:26:23ZengBMCBMC Musculoskeletal Disorders1471-24742010-06-0111111810.1186/1471-2474-11-118Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trialShin ImLee HyangsookPark Hi-JoonLee Jun-HwanSong Mi-Yeon<p>Abstract</p> <p>Background</p> <p>Use of acupuncture has widely increased in patients with chronic low back pain. However, the evidence supporting its efficacy remains unclear. In this article, we report the design and the protocol of a multi-center randomized sham-controlled trial to treat chronic low back pain. Our goal is to verify the effect of acupuncture on chronic low back pain.</p> <p>Methods/Design</p> <p>This study is a multi-center randomized sham-controlled trial with 2 parallel arms. Participants included in the study met the following criteria: 1) low back pain lasting for at least the last 3 months, 2) a documented ≥ 5 points on a 10 cm visual analog scale for bothersomeness of low back pain at the time of screening and 3) between 18 and 65 years of age. Participants were blinded to the real and sham acupuncture treatments. The real acupuncture treatment group received real acupuncture 2 times a week, during a total of 12 sessions over 6 weeks. The control group received sham acupuncture during the same period. In order to assess the primary and secondary outcome measures, the participants were asked to fill out a questionnaire at the baseline and 6, 8, 12 and 24 weeks after starting the treatments. The primary outcome was measured using the visual analog scale for bothersomeness of low back pain at 8 weeks after the initiation of treatments.</p> <p>Discussion</p> <p>The result of this trial (which will be available in 2010) will demonstrate the efficacy of using acupuncture to treat chronic low back pain.</p> <p>Trial registration</p> <p>This study is registered with the U.S. National Institutes of Health Clinical Trials registry: NCT00815529</p>http://www.biomedcentral.com/1471-2474/11/118
spellingShingle Shin Im
Lee Hyangsook
Park Hi-Joon
Lee Jun-Hwan
Song Mi-Yeon
Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial
BMC Musculoskeletal Disorders
title Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial
title_full Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial
title_fullStr Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial
title_full_unstemmed Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial
title_short Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial
title_sort acupuncture for chronic low back pain protocol for a multicenter randomized sham controlled trial
url http://www.biomedcentral.com/1471-2474/11/118
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