ABSTRACT
BACKGROUND: A biopsychosocial rehabilitation is recommended for chronic nonspecific low back pain (CNLBP); however, its effectiveness compared to the traditional supervised exercise therapy of CNLBP treatment is still unclear. METHODS: This was a parallel-group randomized controlled clinical trial. The sample consisted of 180 participants of both sexes, aged ≥18 years, with CNLBP for ≥3 months. Using web randomization and concealed allocation, they were assigned to three groups; graded activity receiving cognitive-behavioral therapy, group-based combined exercise therapy and education (GA; n = 59), supervised group-based combined exercise therapy and education (SET; n = 63), and a control group receiving usual care (n = 58). Interventions were administered for 4 weeks (8 sessions). The primary outcome was pain intensity. Outcome measures were collected baseline, after interventions (4 weeks), and during two follow-up periods (3 and 6 months). RESULTS: After the intervention, GA had a significant large effect on pain reduction compared to the control group (MD of 22.64 points; 95% CI = 16.10 to 29.19; p < 0.0001; Cohen's d = 1.70), as well as SET compared with the control group (MD of 21.08 points; 95% CI = 14.64 to 27.52; p < 0.0001; Cohen's d = 1.39), without significant difference between two intervention groups. At 3 and 6 months of follow-up, GA had a statistically significantly better effect in reducing pain, disability and fear-avoidance beliefs, and improving spinal extensor endurance, range of extension and quality of life compared to SET and the control group. A statistically significantly better effect of SET compared with the control group was found in reducing pain, disability, fear-avoidance beliefs, and improving the physical component of quality of life. Harms were not reported. CONCLUSION: This study suggests that graded activity and group-based supervised exercise therapy have beneficial effects over the control group in the treatment of CNLBP. The graded activity was more beneficial than supervised group-based exercise therapy only during the follow-up. TRIAL REGISTRATION: Clinicaltrials.gov (NCT04023162; registration date: 17/07/2019).
