Abstract
Parkin-Smith GF, Norman IJ, Briggs E, Angier E, Wood TG, Brantingham JW. A structured
protocol of evidence-based conservative care compared with usual care for acute nonspecific
low back pain: a randomized clinical trial.
Objective
To compare a protocol of evidence-based conservative care with usual care for acute
nonspecific low back pain (LBP) of less than 6 weeks' duration.
Design
Parallel-group randomized trial.
Setting
Three practices in the United Kingdom.
Participants
Convenience sample of 149 eligible patients were invited to participate in the study,
with 118 volunteers being consented and randomly allocated to a treatment group.
Interventions
The experimental group received evidence-based treatments for acute nonspecific LBP
as prescribed in a structured protocol of care developed for this study. The control
group received usual conservative care. Participants in both groups could receive
up to 7 treatments over a 4-week period.
Main Outcome Measures
Oswestry Low Back Disability Index (ODI), visual analog scale (VAS), and Patient Satisfaction
Questionnaire, alongside estimation of clinically meaningful outcomes.
Results
Total dropout rate was 14% (n=16), with 13% of data missing. Missing data were replaced
using a multiple imputation method. Participants in both groups received an average
of 6 treatments. There was no statistically significant difference in disability (ODI)
scores at the end of week 4 (P=.33), but there was for pain (VAS) scores (P<.001). Interestingly, there were statistically significant differences between the
2 groups for both disability and pain measures at the midpoint of the treatment period
(P<.001). Patient satisfaction with care was equally high (85%) in both groups. Minimally
clinically important differences in scores and number needed to treat scores (NNT<6)
indicated that the experimental treatment (protocol of care) offered a clinically
meaningful benefit over the control treatment (usual care), particularly at the midpoint
of the treatment period.
Conclusions
Overall, the 2 treatment groups were similar based on primary or secondary outcome
measure scores for the full treatment period (4 weeks, with up to 7 treatments). However,
there were statistically significant and clinically meaningful differences in both
disability and pain scores at week 2 (midpoint) with 4 treatments, suggesting that
the protocol of care had a more rapid effect than usual care.
Key Words
List of Abbreviations:
ANCOVA (analysis of covariance), LBP (low back pain), MCID (minimally clinically important difference), MMT (manual and manipulative therapy), NNT (number needed to treat), ODI (Oswestry Low Back Disability Index), PSQ (Patient Satisfaction Questionnaire), VAS (visual analog scale)To read this article in full you will need to make a payment
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Article info
Footnotes
No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.
Australia New Zealand Clinical Trials Registration Number: ANZCTR12610000530022.
Identification
Copyright
© 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
