Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial
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- 作者：Hyun-jong Lee (1)
Jung-Chul Seo (2)
Min-Ah Kwak (3)
Sung-Hoon Park (2)
Bo-Mi Min (4)
Min-su Cho (4)
ImHee Shin (5)
Jin-yong Jung (4)
Woon-seok Roh (4)
1. Department of Acupuncture & Moxibustion ; College of Oriental Medicine ; Daegu Haany University ; Daegu ; 165 Sang-dong ; Suseong-gu ; Daegu ; 706-060 ; Republic of Korea
2. Comprehensive and Integrative Medicine Institute ; Daegu ; 3056-6 Daemyeong 4-dong ; Nam-gu ; Daegu ; 705-718 ; Republic of Korea
3. Department of Internal Medicine ; College of Oriental Medicine ; Daegu Haany University ; Daegu ; 165 Sang-dong ; Suseong-gu ; Daegu ; 706-060 ; Republic of Korea
4. Department of Anesthesiology and Pain Medicine ; School of Medicine ; Catholic University of Daegu ; Daegu ; 3056-6 Daemyeong 4-dong ; Nam-gu ; Daegu ; 705-718 ; Republic of Korea
5. Department of Medical Statistics ; School of Medicine ; Catholic University of Daegu ; Daegu ; 3056-6 Daemyeong 4-dong ; Nam-gu ; Daegu ; 705-718 ; Republic of Korea - 关键词：Acupuncture ; Interlaminar epidural steroid injection ; Spondylolisthesis
- 刊名：Trials
- 出版年：2014
- 出版时间：December 2014
- 年：2014
- 卷：15
- 期：1
- 全文大小：225 KB
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- 出版者：BioMed Central
- ISSN：1745-6215
文摘
Background Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis. Methods/Design The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation). Discussion This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis. Trial registration This trial is registered with the US National Institutes of Health Clinical Trials registry: NCT01909284.