Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467].
BACKGROUND
Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60-70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis.


METHODS
Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results.


CONCLUSIONS
This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment.
Vas
Jorge
J
Unidad de Tratamiento del Dolor, Centro de Salud Dos Hermanas A, Segovia s/n, 41700 Dos Hermanas, Spain. jvas@acmas.com
Perea-Milla
Emilio
E
Mendez
Camila
C
Silva
Luis Carlos
LC
Herrera Galante
Antonia
A
Aranda Regules
Jose Manuel
JM
Martinez Barquin
Dulce M
DM
Aguilar
Inmaculada
I
Faus
Vicente
V
D000082:Acetaminophen / Q000627:therapeutic use; D026881:Acupuncture / Q000191:economics; D000208:Acute Disease; D000328:Adult; D000639:Amitriptyline / Q000031:analogs & derivatives / Q000627:therapeutic use; D000700:Analgesics / Q000627:therapeutic use; D001499:Bayes Theorem; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004008:Diclofenac / Q000627:therapeutic use; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D017116:Low Back Pain / Q000175:diagnosis / Q000628:therapy*; D015337:Multicenter Studies as Topic / Q000379:methods*; D010147:Pain Measurement; D017060:Patient Satisfaction; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome
D000700:Analgesics; D004008:Diclofenac; D000639:Amitriptyline; D000082:Acetaminophen; C004704:cyclobenzaprine; D007052:Ibuprofen