Evidence-Based Medicine Online First, published on January 27, 2016 as 10.1136/ebmed-2015-110350 Therapeutics/Prevention

Randomised controlled trial

Four sessions of spinal manipulation, simple exercises and education are not better than usual care for patients with acute low back pain 10.1136/ebmed-2015-110350 Leonardo Oliveira Pena Costa Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Sao Paulo, Brazil Correspondence to: Leonardo Oliveira Pena Costa, Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno 448, Tatuapé, São Paulo 03071-000, Brazil; [email protected]

Commentary on: Fritz JM, Magel JS, McFadden M, et al. Early physical therapy vs usual care in patients with recent-onset low back pain: a randomized clinical trial. JAMA 2015;314:14.

Context Although there is evidence from observational studies that early physiotherapy reduces costs associated with treatment in patients with acute low back pain (LBP), current guidelines do not endorse early physiotherapy for these patients. This randomised controlled trial is the first study aiming to investigate if early physiotherapy is better than usual care for this population.

Methods This trial recruited 220 adult patients with acute LBP no more than 16 days from the onset of symptoms, without symptoms distal to the knee and with an Oswestry Disability Index score of 20 or higher. Patients with serious spinal pathologies, nerve root compromise, pregnancy and previous lumbar surgery were excluded. A clinical prediction rule was used to select patients who were more likely to benefit from spinal manipulation. Patients were randomly allocated to one of two groups. Concealed allocation was achieved by using sealed opaque envelopes. Patients from both groups were educated about favourable prognosis of acute LBP and were advised to stay active. They also received a copy of the back book. Patients from the usual care group received their care from their physician and were advised to receive their care as needed. Patients from the early physiotherapy group received a total of four sessions of treatment over 3 weeks. This programme involved spinal manipulation and progressive range of motion and specific stabilisation exercises. Outcomes were measured at baseline, 1, 3 and 12 months after randomisation. The outcomes were: disability, pain intensity, catastrophisation, fear avoidance beliefs and a global measure of change. The primary outcome was disability at 3 months. All outcomes were measured by a blinded assessor at 4 weeks and through a website for the remaining time points. Treatment providers and patients were not blinded.

Findings Early physiotherapy was better than usual care for the primary outcome of disability at 3 months with a mean difference of −3.2 points (95% CI −5.9 to −0.47). This difference, although statistically significant, cannot be considered as clinically relevant (minimal clinically important difference, 6 points). Most between-group differences related to secondary outcomes were neither statistically significant nor clinically relevant in favour of the early physiotherapy group, including differences in pain or healthcare utilisation.

Commentary This is the first randomised controlled trial that has investigated the effects of early use of general spinal manipulation and exercises in patients with acute low back pain. Given that the prognosis of patients with acute LBP is favourable in a large proportion of patients,1 the results of this trial are not surprising. Based on previous studies on the effects of usual care in patients with acute LBP, it is almost impossible to meet an effect larger than the minimal clinical important difference. We should consider stopping doing clinical trials in this group with highly favourable prognosis. Most of these patients only need good advice and reassurance. On the other hand, clinical trials recruiting patients with poorer prognosis are strongly needed. One limitation of this trial is related to the clinical prediction rule used. Patients were selected on two criteria: duration of symptoms lower than 16 days and no pain or numbness distal to the knee. There is evidence that these two criteria have a small positive likelihood ratio of 1.18 (95% CI 1.09 to 1.42). However, the full clinical prediction rule for manipulation is based on five criteria.2 The presence of four of five criteria increases the likelihood of success from 45% to 95% ( positive likelihood ratio=24.4 (95% CI 4.6 to 139.4)). With regards to the exercise programme, it seems that the treatment provided was quite standardised (ie, not tailored to patient’s presentation) and only delivered for a small period of time (4 sessions). This type of exercise programme may not be generalisable for many physiotherapy settings and caution must be taken while interpreting the results of this trial. Finally, a common issue in physiotherapy trials is to name physiotherapy as an intervention. The interventions used in this trial are only a fraction of what physiotherapists use in their clinical practice. Branding these interventions as physiotherapy is misleading for patients, media and stakeholders.

Implications for practice Patients with good prognosis usually benefit from simple, good quality primary care treatment. Physiotherapy-specific care should be considered for patients with moderate to high risk to become chronic. Twitter Follow Leonardo Oliveira Pena Costa at @lcos3060 Competing interests None declared. Provenance and peer review Commissioned; internally peer reviewed. References 1. da C Menezes Costa L, Maher CG, Hancock MJ, et al. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ 2012;184:E613–24. 2. Flynn T, Fritz J, Whitman J, et al. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine 2002;27:2835–43.

Evid Based Med Month 2016 | volume 0 | number 0 |

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Four sessions of spinal manipulation, simple exercises and education are not better than usual care for patients with acute low back pain.

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