Immediate effects of a novel lumbar support device on pain modulation and core muscle function in patients with chronic non-specific low back pain: A randomized controlled trial

Background. A novel lumbar support device to be used by people with chronic nonspecific low back pain (CNLBP) was designed, developed and tested in this trial. The study investigated the immediate effects of the novel lumbar support device on pain modulation and core muscle function in comparison to the traditional lumbar support among people with CNLBP. Methods. This study was a single-blinded, repeated measures, randomized controlled trial with four parallel groups design. A total of 80 patients with CNLBP were randomly allocated using stratified block randomization by pain severity to one of the four groups: traditional lumbar support (TLS) as a control group (N = 20), novel lumbar support with hot pack (NLSD + HP) (N = 20), novel lumbar support with biofeedback device (NLSD + BO) (N = 20), and finally the novel lumbar support with an in-built hot pack and biofeedback device (NLSD + HP with BO) as an experimental intervention group (N = 20). Pain intensity (PI), tissue blood flow (TBF), cold pain threshold (CPT), hot pain threshold (HPT), thickness of transversus abdominis muscle (TrA), and lumbopelvic stability (LPS) were assessed at baseline and immediately post-intervention by a blinded assessor. A two-way repeated-measures ANOVA with post-hoc analysis was used to analyze the data. Results. All 80 participants across the 4 groups had similar outcome measures at baseline (p>0.05). Among the participants in the NLSD + HP with BO (Group 4), a significant interaction was noticed in all of the primary outcomes including PI (p < 0.001), TBF (p < 0.001), CPT (p < 0.001), HPT (p<0.001), PPT (p < 0.001), TrA thickness (p < 0.001) and as well as on the secondary outcome lumbopelvic stability (p < 0.001). Post hoc analysis showed that the results from the NLSD + HP with BO (Group 4) was superior than the TLS group in all of the primary and secondary outcomes (p<0.05). Conclusion. The immediate effects of the NLSD + HP with BO demonstrated potential beneficial outcomes on PI, PPT, CPT, HPT, TrA and LPS in comparison to TLS among participants with CNLBP. Further clinical trial evaluating the long-term clinical effects of the novel lumbar support device is needed to understand the overall benefits of the device and its usefulness for people with CNLBP.