Integration of a Mobilisation Device into a Multidisciplinary Rehabilitation Programme for Chronic Low Back Pain: A Pilot Randomised Controlled Trial

Background: Multidisciplinary rehabilitation programmes (MRPs) are recommended to reduce pain and disability in chronic low back pain (CLBP); however, their efficacy remains uncertain due to variability in study quality. This pilot study aimed to determine the effect of integrating the LumbaCure® device (ODIX s.a., Belgium), a seat designed to mobilise the lower back, into an MRP, compared with the standard MRP, on disability. Methods: In this randomised, open-label, controlled pilot study, adults with non-specific CLBP were assigned to a standard Belgian MRP or the same programme including 15 min of LumbaCure® per session. The primary outcome was the between-group difference in relative change in disability (Oswestry Disability Index, ODI) from baseline to the end of intervention period. Secondary outcomes included pain intensity, the Tampa Scale for Kinesiophobia-17, Pain Catastrophizing Scale (PCS), Patient-Specific Functional Scale, participant satisfaction, and safety. Analyses included all randomised participants. Statistical significance was set at p < 0.05; Cohen’s d effect sizes are reported as an estimate of magnitude, given the exploratory nature of this pilot study. Results: Of 50 randomised participants, 34 completed the study (16 Control, 18 LumbaCure®), with no device-related dropouts. At the intervention end, the change in ODI score did not differ significantly between groups, although it was larger in the LumbaCure® group (Cohen’s d = 0.42). Most secondary outcomes improved more in the LumbaCure® group, but the between-group difference was only significant for the PCS. Within-group improvements at the intervention end were consistently significant for all outcomes in the LumbaCure® group, but none reached significance in the Control group. No serious adverse events were identified. Conclusions: The integration of LumbaCure® into a standard Belgian MRP enhanced improvements in disability and pain catastrophising. These preliminary findings suggest that a larger, adequately powered randomised controlled trial is warranted. Trial registration: ClinicalTrials.gov: NCT06662032 on 16 October 2024, Retrospectively registered