Abstract
BackgroundLow back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally. Current guidelines for the treatment of LBP recommend pharmacological and non-pharmacological strategies. The aim of this study was to compare usual clinical practice with the effectiveness of a biopsychosocial multidisciplinary intervention in reducing disability, severity of pain and improving quality of life in a working population of patients with subacute (2–12 weeks), non-specific LBP.MethodsLongitudinal cluster randomized clinical trial conducted in 39 Primary Health Care Centres (PHCC) of Barcelona, with patients aged 18–65 years (n = 501; control group = 239; 26 PHCC, intervention group = 262; 13 PHCC). The control group received usual clinical care. The intervention group received usual clinical care plus a biopsychosocial multidisciplinary intervention, which consisted of physiotherapy, cognitive-behavioural therapy and medication. The main outcomes were changes in the Roland Morris Disability Questionnaire (RMDQ), and the minimal clinically important differences. Secondary outcomes were changes in the McGill Pain (MGPQ) and Quality of Life (SF-12) questionnaires. Assessment was conducted at baseline, 3 and 12 months. Analysis was by intention-to-treat and analyst-blinded. Multiple imputations were used.ResultsOf the 501 enrolled patients, 421 (84%) provided data at 3 months, and 387 (77.2%) at 12 months. Mean age was 46.8 years (SD: 11.5) and 64.7% were women. In the adjusted analysis of the RMDQ outcome, only the intervention group showed significant changes at 3 months (− 1.33 points, p = 0.005) and at 12 months (− 1.11 points, p = 0.027), but minimal clinically important difference were detected in both groups. In the adjusted analysis of the RMDQ outcome, the intervention group improvement more than the control group at 3 months (− 1.33 points, p = 0.005) and at 12 months (− 1.11 points, p = 0.027). The intervention group presented a significant difference. Both groups presented a minimal clinically important difference, but more difference in the intervention group. The intervention group presented significant differences in the MGPQ scales of current pain intensity and VAS scores at 3 months. No statistically significant differences were found in the physical and mental domains of the SF-12.ConclusionsA multidisciplinary biopsychosocial intervention in a working population with non-specific subacute LBP has a small positive impact on disability, and on the level of pain, mainly at short-term, but no difference on quality of life.Trial registrationISRCTN21392091 (17 oct 2018) (Prospectively registred).
Highlights
Low back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally
In the adjusted analysis of the Roland Morris Disability Questionnaire (RMDQ) outcome, only the intervention group showed significant changes at 3 months (− 1.33 points, p = 0.005) and at 12 months (− 1.11 points, p = 0.027), but minimal clinically important difference were detected in both groups
A total of 501 subjects were included in the study; 262 subjects (13 Primary Health Care Centres (PHCC)) were allocated to the intervention group and 239 subjects (26 PHCC) to the control group
Summary
Low back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally. Low back pain (LBP) is a common health problem that affects approximately 80–85% of the general population at least once in their lifetime and has a global prevalence between 17 and 32%, of which 11–12% are disabled by this condition [1, 2]. Despite the wide range of treatments and health-care resources devoted to LBP, back-related disability and burden have increased, in recent years [6]. A study carried out in 36 Primary Health Care Centres (PHCC) in Spain showed that despite guideline-based management, the pain continued in 37% and had worsened in 10% of patients after two months [7]. The natural history of LBP can be extremely variable and recurrences are common, with, approximately 65% of patients still experiencing pain one year after the onset of this condition [8, 9]
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