• Spine · Jul 2012

    Randomized Controlled Trial Comparative Study

    A randomized controlled trial on the effectiveness of a classification-based system for subacute and chronic low back pain.

    • Adri T Apeldoorn, Raymond W Ostelo, Hans van Helvoirt, Julie M Fritz, Dirk L Knol, Maurits W van Tulder, and Henrica C W de Vet.
    • Department of Epidemiology and Biostatistics and the EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. a.apeldoorn@vumc.nl
    • Spine. 2012 Jul 15;37(16):1347-56.

    Study DesignA randomized controlled trial.ObjectiveTo assess the effectiveness of Delitto's classification-based treatment approach compared with usual physical therapy care in patients with subacute or chronic low back pain.Summary Of Background DataNo trial has evaluated this approach in patients with subacute and chronic low back pain.MethodsBefore randomization, all patients were classified by research physical therapists according to a modified version of Delitto's classification-based system. Randomization was computer-generated, with centralized allocation concealment. The statistician and the physical therapists were unblinded. Patients and assistants who collected follow-up questionnaires were blinded. Follow-up assessments were completed at 8, 26, and 52 weeks. The primary analysis was performed according to the intention-to-treat principle, using multilevel analysis. The main outcomes were global perceived effect, disability (Oswestry Disability Index, 0-100), and pain intensity (Numerical Rating Scale, 0-10). Secondary outcomes were quality of life, fear-avoidance beliefs, and psychosocial status. RESULTS.: A total of 156 patients were included (classification-based group, n = 74; usual physical therapy group, n = 82). There were no statistically significant differences between the treatment groups for any of the outcomes at any of the follow-up time points. After 8 weeks, patients in the classification-based group had greater global perceived effect scores; adjusted odds ratio of 1.01 (95% confidence interval [CI], 0.31 to 3.28), and higher adjusted Oswestry Disability Index and Numerical Rating Scale scores; mean adjusted differences of 0.48 points (95% CI, -4.59 to 3.63) and 0.49 points (95% CI, -1.34 to 0.37) respectively, but all differences were statistically nonsignificant.ConclusionThe classification-based system used in this study was not effective for improving physical therapy care outcomes in a population of patients with subacute and chronic low back pain.

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