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A Randomized Controlled Trial on the Effectiveness of a Classification-Based System for Subacute and Chronic Low Back Pain

Apeldoorn, Adri T. PhD*,†; Ostelo, Raymond W. PhD*,‡; van Helvoirt, Hans MA§; Fritz, Julie M. PhD; Knol, Dirk L. PhD*; van Tulder, Maurits W. PhD*,‡; de Vet, Henrica CW PhD*

doi: 10.1097/BRS.0b013e31824d9f2b
Randomized Trial

Study Design. A randomized controlled trial.

Objective. To 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 Data. No trial has evaluated this approach in patients with subacute and chronic low back pain.

Methods. Before 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.

Conclusion. The 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.

Patients with subacute and chronic low back pain were randomly assigned to receive treatment on the basis of a modified version of Delitto's classification–based treatment approach or usual physical therapy care. This randomized controlled trial found that this approach did not improve usual physical therapy care outcomes in this population.

*Department of Epidemiology and Biostatistics and the EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands;

Medical Centre Alkmaar, Alkmaar, the Netherlands

Department of Health Sciences and the EMGO+ Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University, Amsterdam, the Netherlands

§Medical Back Neck Centre, The Hague, the Netherlands

Department of Physical Therapy, University of Utah, and Intermountain Health Care, Salt Lake City, UT

Address correspondence and reprint requests to Adri T. Apeldoorn, PhD, Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, VU University Medical Centre, Van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands; E-mail: a.apeldoorn@vumc.nl

Acknowledgment date: July 12, 2011. First revision date: December 10, 2011. Acceptance date: January 30, 2012.

The manuscript submitted does not contain information about medical device(s)/drug(s).

The Netherlands Organisation for Health Research and Development grant funds were received to support this work.

No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.

© 2012 Lippincott Williams & Wilkins, Inc.