Abstract
BackgroundLow 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/DesignRandomised 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.DiscussionThis 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.
Highlights
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
Improvement perceived by the patient (IPP) A Likert-type scale of 7 points is recommended for evaluating the improvement perceived by the patient with nonspecific low back pain [40], but opinions differ concerning the categories to be used
Clinical experience has shown that uncomplicated lumbalgia responds rapidly to acupuncture, which achieves a reduction in pain intensity and duration, and contributes to the prompt return of patients to their normal working activity
Summary
Various excellent studies have analysed the effects of acupuncture on chronic acute low back pain, for example Brinkhaus et al [50]. The choice of acupuncture points for the study group treated with genuine acupuncture was based on 'distance puncture', taking into consideration the standard categories of acute low back pain according to TCM. The doctors participating in the project were free to select up to 4 points, but were required to justify their decision Another important consideration is the use of 'dynamic puncture' (xingzhen), which in most cases facilitates immediate analgesia. The group that was given placebo acupuncture, completely inert, served to isolate the non-specific effects of acupuncture treatment; this group received the same number of sessions as did the experimental group, the same evaluation procedure, the same physical contact and the impression of having received real acupuncture treatment. A placebo must be inert, and so the method adopted (with no penetration of the skin), we believe, is the most valid one
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