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Randomized Clinical Trial

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

Author/s: 
Laurent Grange, Paul Calmels, Yves-Marie Pers, Guillaume Laustriat, Valerie Wieczorek, Nassima Saih, Mathieu De-Seze, Christelle Nguyen, Camille Daste, Isabelle Fayolle-Minon, Emmanuel Coudeyre, Francois Rannou

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.

Keywords 
Nonspecific Low Back Pain Randomized Clinical Trial Adults

Cost-effectiveness of Physical Therapy vs Intra-articular Glucocorticoid Injection for Knee Osteoarthritis: A Secondary Analysis From a Randomized Clinical Trial

Author/s: 
Rhon, D. I., Kim, M., Asche, C. V., Allison, S. C., Allen, C. S., Deyle, G. D.

Importance: Physical therapy and glucocorticoid injections are initial treatment options for knee osteoarthritis, but available data indicate that most patients receive one or the other, suggesting they may be competing interventions. The initial cost difference for treatment can be substantial, with physical therapy often being more expensive at the outset, and cost-effectiveness analysis can aid patients and clinicians in making decisions.

Objective: To investigate the incremental cost-effectiveness between physical therapy and intra-articular glucocorticoid injection as initial treatment strategies for knee osteoarthritis.

Design, setting, and participants: This economic evaluation is a secondary analysis of a randomized clinical trial performed from October 1, 2012, to May 4, 2017. Health economists were blinded to study outcomes and treatment allocation. A randomized sample of patients seen in primary care and physical therapy clinics with a radiographically confirmed diagnosis of knee osteoarthritis were evaluated from the clinical trial with 96.2% follow-up at 1 year.

Interventions: Physical therapy or glucocorticoid injection.

Main outcomes and measures: The main outcome was incremental cost-effectiveness between 2 alternative treatments. Acceptability curves of bootstrapped incremental cost-effectiveness ratios (ICERs) were used to identify the proportion of ICERs under the specific willingness-to-pay level ($50 000-$100 000). Health care system costs (total and knee related) and health-related quality-of-life based on quality-adjusted life-years (QALYs) were obtained.

Results: A total of 156 participants (mean [SD] age, 56.1 [8.7] years; 81 [51.9%] male) were randomized 1:1 and followed up for 1 year. Mean (SD) 1-year knee-related medical costs were $2113 ($4224) in the glucocorticoid injection group and $2131 ($1015) in the physical therapy group. The mean difference in QALY significantly favored physical therapy at 1 year (0.076; 95% CI, 0.02-0.126; P = .003). Physical therapy was the more cost-effective intervention, with an ICER of $8103 for knee-related medical costs, with a 99.2% probability that results fall below the willingness-to-pay threshold of $100 000.

Conclusions and relevance: A course of physical therapy was cost-effective compared with a course of glucocorticoid injections for patients with knee osteoarthritis. These results suggest that, although the initial cost of delivering physical therapy may be higher than an initial course of glucocorticoid injections, 1-year total knee-related costs are equivalent, and greater improvement in QALYs may justify the initial higher costs.

Keywords 
physical therapy Knee osteoarthritis Randomized Clinical Trial Glucocorticoid Injection
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