Clinical relevance of combined treatment with exercise in patients with chronic low back pain: a randomized controlled trial

Low back pain is a widespread public health concern owing to its high prevalence rates according to the Global Burden of Diseases. This study aimed to investigate the effect of exercise alone or in combination with manual therapy and kinesiotherapy on pain sensitivity, disability, kinesiophobia, self-efficacy, and catastrophizing in patients with chronic low back pain (CLBP). A total of 55 participants were enrolled and randomly allocated to one of three groups: (1) exercise alone group (ET; n = 19), (2) exercise + manual therapy group (ETManual therapy; n = 18), and (3) exercise + kinesio tape group (ETkinesiotape; n = 18). The interventions consisted of core stabilization exercises (ET group), prior spinal manipulation with core exercises (ETManual therapy group), and combined application of kinesiotape plus core stabilization exercises (ETkinesiotape group). The primary outcome was disability. The secondary outcomes were pain sensitization, kinesiophobia, catastrophizing, and self-efficacy. Assessments were performed at baseline and at weeks 3, 6, and 12. All therapies applied achieved significant improvements over time after 12 weeks in all parameters analyzed. ETmanualtherapy showed the greatest changes in all variables, with significant differences from the rest of the interventions in Oswestry (ODI) (3 and 6 weeks, respectively). A clinically significant cutoff point was achieved for the ETmanualtherapy group in the ODI parameter (-54.71%, -63.16% and -87.70% at 3, 6, and 12 weeks, respectively). Manual therapy prior to the core exercise technique was the most effective approach to improve health-related functionality compared with exercise alone or exercise combined with kinesiotape in patients with CLBP.Clinical Trial Registration Number: NCT05544890.