Background & Aims
Multidisciplinary programs that address chronic pain through a biopsychosocial approach are the first recommendation for non-specific chronic low back pain. Disciplines such as pain neuroscience education, therapeutic exercise, cognitive behavioral therapy-based psychotherapy, therapeutic education and mindfulness meditation are five therapies that in isolation have been shown to improve pain and quality of life, among others. However, the implementation of programs that integrate multiple therapies can be complex in terms of resource availability, coordination of health professionals and patient adherence to treatment.
The study aims to evaluate the feasibility and appropriateness of the PAINDOC multidisciplinary program for subjects with chronic low back pain. Secondary objectives are 1) to evaluate the difference in pain intensity, pain-related disability, quality of life, and pain catastrophizing, 2) to calculate the sample size for a future randomized clinical.
Methods
The multidisciplinary treatment program named Comprehensive Care Program for Chronic Pain Patients (PAINDOC) integrates 5 different parts (Empowered Relief®, pain neuroscience education, mindfulness meditation, therapeutic exercise and cognitive behavioral therapy) provided by different health professionals in the pain unit of the Hospital Clinic de Barcelona. It consists of 8 face-to-face group sessions carried out over 2 months.
This study was conducted using 2 different recruitment waves. Firstly, feasibility outcomes (recruitment, completion and drop-out rates) were recorded from a 5-month non-random prospective cohort (n=227). Secondly, clinical outcomes (pain intensity, quality of life, disability, and pain catastrophizing) were recorded using a prospective, controlled, randomized, two-armed, single-blinded feasibility study (ClinicalTrials.gov, NCT05974072) in which 41 participants were randomly allocated to either pharmacological treatment (n=21) or PAINDOC program (n=20).
Results
Recruitment rate was 66%, completion rate was 80,7% and drop-out rate 19,3%. Significant differences and a medium size effect was observed between groups in pain intensity at rest (p=.017, r=.408) at the 4-month follow-up.
Intragroup analysis of the PAINDOC group revealed significant improvements in pain intensity (p=<.001) and quality of life (p=.030) over time.
Sample size estimation was performed using the software G*Power3 and pain intensity using a VAS was used as a primary outcome measure. Thus, with a d=.929, a power of .95, and an ? level of .05, it was estimated that 26 participants would be required for each group (a total sample size of 52). Therefore, accounting for a 20% drop-out rate, the full trial enrollment goal was set to 31 participants per group (a total sample size of 62 subjects).
Conclusions
This study showed that the PAINDOC multidisciplinary program is a feasible and potentially effective treatment in reducing pain intensity and self-reported quality of life in patients with non-specific chronic low back pain. Such intervention could also be beneficial for improving chronic low back pain-related disability and pain catastrophizing. Future studies should seek to clarify whether the PAINDOC program can achieve such improvements.
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