Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial.
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
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).


CONCLUSIONS
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.


BACKGROUND
This trial is registered with the US National Institutes of Health Clinical Trials registry: NCT01909284.
Hyun-Jong
HJ
Lee
Jung-Chul
JC
Seo
Min-Ah
MA
Kwak
Sung-Hoon
SH
Park
Bo-Mi
BM
Min
Min-Su
MS
Cho
ImHee
I
Shin
Jin-Yong
JY
Jung
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. usno@cu.ac.kr.
Woon-Seok
WS
Roh
D015670:Acupuncture Therapy; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D004334:Drug Administration Schedule; D006801:Humans; D007268:Injections, Epidural; D017116:Low Back Pain / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D010147:Pain Measurement; D010865:Pilot Projects; D056910:Republic of Korea; D012107:Research Design; D013168:Spondylolisthesis / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D013256:Steroids / Q000008:administration & dosage; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D013256:Steroids