Effectiveness of Motorised Lumbar Support for Non-specific Low Back Pain

LBP represents a common musculoskeletal conditions, causing substantial disability and economic burden. Several strategies, such as education, exercise, manual therapy, psychological techniques and lumbar supports have been recommended for LBP mangement. While traditional semi-rigid lumbar supports are commonly prescribed to alleviate LBP symptoms, their effectiveness remains limited by their static mechanical properties and lack of adaptability to movement patterns. A motorized lumbar support, may offer a novel approach through application of controlled decompressive forces while maintaining functional mobility. An innovative battery-powered orthosis that provides adjustable traction between thoracic and pelvic components, potentially addressing underlying mechanical factors contributing to pain, will be tested in participants with chronic LBP.

This single-blind, parallel-group clinical trial aims to compare the effectiveness of a motorized lumbar support with that of a standard semi-rigid lumbar support in adults suffering from non-specific LBP. Eligible participants will be adults aged 18 to 65 years experiencing LBP with an average pain score of at least 3 out of 10 in the past week, pain related-disability ≥10% at ODI, and pain relief must be present during manual traction (measured by a moderate improvement (+3) on a global rating of change scale. Exclusion criteria include specific spinal pathologies (e.g., fractures, spinal stenosis, cancer), presence of neuropathic pain (leg and back, of 4 at the DN4), pregnancy, high BMI (\>32), respiratory and circulatory issues, osteoporosis, recent rib or pelvic fractures, and any contraindications to wearing lumbar supports. A total of 70 participants will be randomly assigned to wear either a motorized lumbar support or a semi-rigid lumbar support . The motorized lumbar support is a battery-powered lumbar orthosis with thoracic and abdominal belts connected by lateral supports. It applies adjustable decompression force to the spine while allowing movement. Each participant will be instructed to wear the assigned support for at least four hours per day over three weeks, excluding while sleeping.

To minimize bias in data collection, subjective variables will be evaluated using REDCap while objective variables will be collectedat research centre. The primary outcomes include daily pain intensity and physical functioning. Secondary subjective outcomes include pain-related disability, average pain intensity of the past week, pain catastrophizing, fear of movement, self-efficacy, acceptability and adverse effects.

The statistician performing the statistical analyses will be blinded to group allocation. Linear mixed models incorporating fixed effects for group (motorized vs. standard support), time, and their interaction, with participants included as a random effect will be used. Daily wearing of the lumbar support, age and self-reported sex will be included as covariates. Intention-to-treat will be used for the main analyses. Per-protocol analyses will be conducted as sensitivity analyses, with the latter including only those who adhered to the recommended usage (minimum 4 hours/day, 5 days/week for 3 weeks). The sample size of 70 participants (35 per group) is planned based on the ability to detect a 2-point difference on the pain scale, with 95% power, a significance level of 0.05, and an estimated 20% dropout rate.

• Pain-related disability [Срок оценки: Baseline, week 3 and 9.]
• Pain intensity [Срок оценки: Baseline, week 3 and 9.]
• Pain catastrophizing [Срок оценки: Baseline, week 3 and 9.]
• Fear of movement [Срок оценки: Baseline, week 3 and 9.]
• Pain self-efficacy [Срок оценки: Baseline, week 3 and 9.]
• Acceptability [Срок оценки: Week 3]
• Acceptance [Срок оценки: 3 weeks]
• Adverse events [Срок оценки: 3 weeks]