Lumbar Belt for Nonspecific Low Back Pain
Laurent Grange, Paul Calmels, Yves-Marie Pers, Guillaume Laustriat, Valérie Wieczorek, Nassima Saih, Mathieu De-Sèze, Christelle Nguyen, Camille Daste, Isabelle Fayolle-Minon, Emmanuel Coudeyre, François RannouImportance
Nonspecific low back pain is highly prevalent and disabling. Most current guidelines state that evidence is insufficient to recommend lumbar belts for this condition.
Objective
To determine whether a soft and extensible lumbar belt reduces functional disability and pain in patients with nonspecific low back pain.
Design, Setting, and Participants
This multicenter, open-label, randomized clinical trial was conducted at 17 medical centers across France from February 26, 2021, to March 28, 2024. Participants were adults with nonspecific low back pain lasting 1 to 6 months. Data were analyzed from August 7, 2024, to June 18, 2025.
Interventions
Patients were randomized using an interactive web response system to wear a nonrigid lumbar belt for 12 weeks in addition to usual care or to receive usual care without a device.
Main Outcomes and Measures
The primary outcome was the between-group difference in mean change in the Oswestry Disability Index (ODI) score from baseline to week 12. Outcomes were assessed at baseline, week 4, and week 12; pain was also reported weekly using online questionnaires.
Results
At total of 168 patients were randomized (mean [SD] age, 49.0 [13.7] years; 101 women [60.1%]), with 86 participants in the belt group and 82 participants in the usual care group. The primary analysis included 155 patients with at least 1 postrandomization assessment (81 patients in the belt group; 74 patients in the control group). ODI improvement from baseline to week 12 was greater in the belt group (change, −10.0 [95% CI, −13.0 to −7.0] points) than in the control group (change, −5.3 [95% CI, −8.6 to −2.1] points), with a between-group difference of −4.7 (95% CI, −8.4 to −0.9) points ( P = .01). Reductions in pain at rest and during activity were also greater in the belt group, with between-group differences of −8.7 (95% CI, −16.1 to −1.3) points ( P = .02) and −10.0 (95% CI, −18.3 to −1.6) points ( P = .02), respectively. Over 12 weeks, medication use was lower in the belt group than in the control group (41 patients [50.6%] vs 50 patients [67.6%]; P = .03). No serious device-related adverse events occurred.
Conclusions and Relevance
In this randomized clinical trial, adding a nonrigid lumbar belt to usual care resulted in improved pain and functional disability in patients with nonspecific low back pain lasting 1 to 6 months. These findings suggest that lumbar belts may be considered as a nonpharmacological option for symptom management.
Trial Registration
ClinicalTrials.gov Identifier: