Objective: To evaluate the effect on disability, kinesiophobia, pain, and the quality of life of a long-lasting multidisciplinary program based on cognitive-behavioral therapy and targeted against fear-avoidance beliefs in patients with chronic low back pain.
Methods: Study design: parallel-group, randomized, superiority controlled study. Ninety patients were randomly assigned to a multidisciplinary program consisting of cognitive-behavior therapy and exercise training (experimental group, 45 patients) or exercise training alone (control group, 45 patients). Before treatment (T1), 5 weeks later (instructive phase, T2), and 12 (posttreatment analysis, T3) and 24 months after the end of the instructive phase (1-year follow-up, T4), all of the patients completed a booklet containing the Roland-Morris Disability Questionnaire Scale (primary outcome), the Tampa Scale for Kinesiophobia, a pain numerical rating scale, and the Short-Form Health Survey. A linear mixed model for repeated measures was used to analyze each outcome measure, and the reliable change index/clinically significant change method was used to assess the clinical significance of the changes.
Results: The linear mixed model analysis showed a remarkable group, time, and interaction effect for group * time in all of the primary and secondary outcomes (P always <0.001). The majority of the patients in the experimental group achieved a reliable and clinically significant improvement, whereas the majority of those in the control group experienced no change.
Conclusions: The long-lasting multidisciplinary program was superior to the exercise program in reducing disability, fear-avoidance beliefs and pain, and enhancing the quality of life of patients with chronic low back pain. The effects were clinically tangible and lasted for at least 1 year after the intervention ended.
*Physical Medicine and Rehabilitation Unit, Scientific Institute of Lissone (Milan), Institute of Care and Research, Salvatore Maugeri Foundation, IRCCS
†Neuroengineering and Medical Robotics Laboratory, Bioengineering Department, Politecnico di Milano
‡Consorzio Valutazioni Biologiche e Farmacologiche, Pavia University and Scientific Institute of Pavia, Institute of Care and Research, Salvatore Maugeri Foundation, IRCCS, Milan
§Physical and Rehabilitation Medicine, Tor Vergata University of Rome, Rome, Italy
The authors declare no conflict of interest.
Reprints: Marco Monticone, MD, PhD, Via Monsignor Bernasconi 16, 20035 Lissone MI, Milan, Italy (e-mail: firstname.lastname@example.org).
Received December 14, 2011
Accepted November 26, 2012