Effects of osteopathic manipulative treatment associated with transcranial direct current stimulation in individuals with chronic low back pain: A double-blind, randomised placebo-controlled trial

Objective To evaluate the effectiveness of osteopathic manipulative treatment (OMT) associated with transcranial direct current stimulation (tDCS) in reducing pain, disability, and improving quality of life in participants with non-specific chronic low back pain. Design A randomised double-blind clinical trial. Setting Clinical outpatient unit. Subjects 72 participants with non-specific chronic low back pain were randomised into three groups: active tDCS + OMT (n = 24), sham tDCS + sham OMT (n = 24), and sham tDCS + OMT (n = 24). Interventions Evaluations were performed before, after the intervention, and one month post-intervention. tDCS consisted of ten 20-minute sessions over two weeks (five sessions per week). OMT was administered once per week, with two sessions conducted before the first and sixth tDCS sessions. Main measures Pain, disability, and quality of life were assessed at baseline, after two weeks, and at one month of follow-up. Results The visual analogue scale showed a significant decrease in all groups (p < 0.001). However, tDCS + OMT and sham tDCS + OMT demonstrated a clinically significant reduction compared to the sham combination (effect size n(2) = 0.315). Roland-Morris scores decreased across all groups without specific group effects. EuroQoL 5-Dimension 3-Level improvement was observed only in the tDCS + OMT and sham tDCS + OMT groups (significant difference between T2 and T0, p = 0.002). Conclusion The combination of OMT and tDCS did not provide clinically significant improvement over OMT alone in participants with non-specific chronic low back pain.