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Publications

Journal Article Randomized Controlled Trial Multicenter Study Epublish

PubMed: 42616499 DOI: 10.1001/jamanetworkopen.2026.29793

Lumbar Belt for Nonspecific Low Back Pain: A Randomized Clinical Trial.

JAMA Netw Open 9(8):e2629793

Authors: 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 Rannou

Affiliations

  • University Grenoble Alpes, Grenoble Alpes University Hospital, Rheumatology Department, Sud Hospital, Grenoble, France.
  • Inter-University Laboratory of Human Movement Biology, Physical Ability and Fatigue in Health and Disease Team (F-42023), Universities of Saint-Etienne Jean Monnet, Lyon 1, & Savoie Mont-Blanc, Saint-Etienne, France.
  • Institute for Regenerative Medicine and Biotherapy, Univ Montpellier, INSERM UMR 1183, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHU Montpellier, Montpellier, France.
  • Department of Rheumatology, Tarbes-Lourdes Hospital, Tarbes, France.
  • Pôle RRSS, Lille CHU Hospital, Lille, France.
  • Rheumatology Department, Protestant Infirmary, Caluire-et-Cuire, France.
  • Department of Physical Medicine and Rehabilitation, Bordeaux CHU Hospital, Bordeaux, France.
  • AP-HP Paris City University: Rehabilitation Service for the Locomotor System and Spinal Pathologies, Cochin Hospital, Paris, France.
  • Faculty of Medicine, Paris City University, Paris, France.
  • INSERM UMR-S 1124 - HealthFex, Saint-Germain-des-Prés Campus, Paris, France.
  • INSERM UMR-S 1153 - Epidemiology and Statistics Research Centre, Paris, France.
  • Department of Physical Medicine and Rehabilitation, University Hospital of Saint-Etienne - Bellevue Hospital, Saint-Etienne, France.
  • Department of Physical Medicine and Rehabilitation-INRAE, UNH, Clermont-Ferrand CHU Hospital, Clermont Auvergne University, Clermont-Ferrand, France.

Abstract

IMPORTANCE

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: NCT04701073.

MeSH

Low Back Pain, Pain, Clinical Medicine, Back Pain