Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trialReportar como inadecuado




Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 15:105

First Online: 02 April 2014Received: 21 October 2013Accepted: 20 March 2014DOI: 10.1186-1745-6215-15-105

Cite this article as: Lee, H., Seo, JC., Kwak, MA. et al. Trials 2014 15: 105. doi:10.1186-1745-6215-15-105

Abstract

BackgroundSpondylolisthesis 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-DesignThe 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.

DiscussionThis 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 registrationThis trial is registered with the US National Institutes of Health Clinical Trials registry:NCT01909284.

KeywordsAcupuncture Interlaminar epidural steroid injection Spondylolisthesis AbbreviationsALTalanine aminotransferase

ASTaspartate aminotransferase

BUNserum urea nitrogen

ESRerythrocyte sedimentation rate

Hcthematocrit

MCHmean corpuscular hemoglobin

MCHCmean corpuscular hemoglobin concentration

MCVmean corpuscular volume

ODIOswestry Disability Index

PPIPresent Pain Intensity

RBCred blood cell

SF-MPQShort form McGill pain questionnaire

VASVisual analogue scale

WBCwhite blood cell.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-105 contains supplementary material, which is available to authorized users.

Hyun-jong Lee, Jung-Chul Seo contributed equally to this work.

Download fulltext PDF



Autor: Hyun-jong Lee - Jung-Chul Seo - Min-Ah Kwak - Sung-Hoon Park - Bo-Mi Min - Min-su Cho - ImHee Shin - Jin-yong Jung - Woon-

Fuente: https://link.springer.com/







Documentos relacionados