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;
lcos3060@gmail.com
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 physio-
therapy reduces costs associated with treatment in patients with acute
low back pain (LBP), current guidelines do not endorse early physiother-
apy 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, preg-
nancy 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 ses-
sions 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 ran-
domisation. The outcomes were: disability, pain intensity, catastrophisa-
tion, 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 differ-
ence, 6 points). Most between-group differences related to secondary out-
comes 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 evi-
dence 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 cri-
teria increases the likelihood of success from 45% to 95% ( positive likeli-
hood 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 physio-
therapy 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.
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