A multidisciplinary pain management program for patients with chronic low back pain: a randomized, single-blind, controlled, feasibility study.
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Multidisciplinary programs are the first recommendation for non-specific chronic low-back pain, but implementing this type of program is complicated to get up and running. The primary aim of this study was to assess the feasibility and appropriateness of the PAINDOC multidisciplinary program for subjects with chronic low-back pain. The secondary objectives were to evaluate the decrease in pain intensity, pain-related disability and pain catastrophizing, as well as the improvement in quality of life with this program. Furthermore, another of the secondary objectives was to calculate the sample size for a future randomized clinical trial./r/nThis study was conducted in a hospital pain unit using two successive recruitment waves. First, the feasibility outcomes (recruitment, completion, and drop-out rates) of a 5-month non-random prospective cohort (n = 227) were recorded. Then, the clinical outcomes (pain intensity, quality of life, disability, and pain catastrophizing) were recorded from a prospective, controlled, two-armed and single-blind feasibility study (ClinicalTrials.gov, NCT05974072). It included 41 participants that were randomly allocated to either the pharmacological treatment (n = 21) arm or PAINDOC program (n = 20) arm./r/nThe recruitment rate was 66%, with the completion rate standing at 80.7% and the drop-out rate at 19.3%. Significant differences and a medium size effect were observed between groups in terms of pain intensity (p = .017, r = .408) at the 4-month follow-up. The intragroup analysis of the PAINDOC group revealed significant lessening in pain intensity (p = < 0.001) and improvements in quality of life (p = .030)./r/nThis study showed that the PAINDOC multidisciplinary program is a feasible treatment for patients with non-specific chronic low-back pain. Furthermore, the exploratory results of this study suggest that it could be an effective treatment to reduce pain intensity and improve on self-reported quality of life in these patients, although a future randomized clinical trial is needed to determine its effectiveness./r/nNCT05974072 (registration date July 11, 2023; retrospectively registered; ClinicalTrials.gov).
