A Structured Protocol of Evidence-based Conservative Care Compared with Usual Care for Acute Nonspecific Low Back Pain: A Randomized Clinical Trial
Gregory F. Parkin-Smith, MTech(Chiro), MSc, DrHC,
Ian J. Norman, BSc, MSc, PhD,
Emma Briggs, BSc, PhD, RN,
Elizabeth Angier, BSc, MSc(Chiro),
Timothy G. Wood, BSc, MTech(Chiro),
James W. Brantingham, DC, PhD
School of Chiropractic & Sports Science,
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.
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