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Low back pain (LBP) represents a common musculoskeletal conditions worlwide, causing substantial disability and economic burden. 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. Motorized lumbar support is a novel approach that allows the application of controlled decompressive forces while maintaining functional mobility. This experimental study aims to compare the effectiveness between a motorized lumbar support and a standard semi-rigid support in adults with non-specific LBP. Seventy adults with non-specific low back pain (LBP) will be recruited. Primary outcomes (pain intensity and physical functioning [daily average]) will be collected daily while secondary outcomes (average pain intensity of the last week, pain-related disability, etc.), and at baseline, 3 weeks, and 9 weeks after randomization.
Full description
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 which 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 compared to 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, similar or more pain in sitting than standing, and at least a 2-point reduction in pain during manual traction. Exclusion criteria include specific spinal pathologies (e.g., fractures, spinal stenosis, cancer), lumbar radiculopathy, pregnancy, high BMI (>32), respiratory 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 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 collected by a blinded evaluator. The primary outcomes include daily pain intensity and physical functioning. Secondary subjective outcomes include pain-related disability, average pain intensity of the last 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 used 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.
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70 participants in 2 patient groups
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Hugo Massé-Alarie, PhD
Data sourced from clinicaltrials.gov
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