Background: Low back pain (LBP) is the number one cause of disability in the world, affecting around 619 million people [1]. Although acute LBP usually improves significantly within 6 weeks [2], recurrence is common, affecting around 33% of patients by 12 months [3]. Recurrent and chronic LBP can lower the quality of life and increase the risk of psychological disorders [4].There is also a substantial economic burden due to the healthcare costs and loss of work productivity.

Objectives: We aimed to determine whether non-rigid lumbar belts can reduce functional disability and pain in patients with non-specific low back pain (nsLBP).

Methods: This was a prospective, multi-centre, open label, parallel group, randomised controlled superiority trial, carried out in 17 medical centres throughout France. Patients with nsLBP for 1–6 months (first or repeat episode) were randomised to wear either an elasticated lumbar belt for 12 weeks (belt group) or no device (control group) in addition to usual care (physical exercise and LBP usual medication). The patients were followed up after 4 weeks (T1) and 12 weeks (T2), and they completed weekly online questionnaires. The main outcome measure was the Oswestry Disability Index (ODI). Other outcome measures included weekly ratings of pain, medication intake for nsLBP, mobility using finger-to-floor test and Schober-Macrae tests, quality of life using CGI-S, CGI-I, PGI-C and EQ-5D questionnaires, compliance using thermal sensors and daily diaries, and safety.

Results: Between February 2021, and March 2024, 168 eligible patients (67 men, 101 women) were recruited. Eighty-one of the 86 patients in the belt group and 74/82 patients in the control group attended the T1 follow-up assessment and were included in the analysis.The two groups were similar in terms of their baseline characteristics, including their age (overall mean: 49·5±13·3 years) and sex. Most patients had recurrent back pain (59·4%), and the current episode had lasted for a mean of 3·1±1·5 months.Between T0 and T2, the belt was worn for a mean of 5.5 ± 1.8 days/week (daily diaries) and 4.5 ± 2.0 days/week (thermal sensors). When the belt was worn, it was worn for 4.9 ± 2.2 h (diaries) and 3.8 ± 1.4 h (sensors) per day (statistically significant correlation between diaries and sensors).The belt group had significantly greater Oswestry Disability Index improvements between baseline and T2 compared to the control group. The group difference was statistically significant (P=.015). For 60.5% of patients in the belt group, the ODI improved by >30% (minimal important difference) vs. 40.5% in the control group (P=.036).The decrease in average pain at rest and during activity was also consistently greater in the belt group from week 1 (P<.05), and fewer patients in this group took medication for back pain (P=.032), particularly non-steroidal anti-inflammatory drugs (NSAIDs) ( P =.012). Lumbopelvic-femoral mobility (finger-to-floor) improved more in the belt group vs. control group, but lumbosacral mobility (Schober-Macrae) changes did not differ significantly between the groups (P=.29). More patients in the belt group reported an improved state of health (CGI-S, CGI-I and PGI-C) vs. the control group from T0 to T2 (P=.029, P<.001 and P=.023 respectively). Mean EQ-5D scores increased in both groups (P=.11). There were no serious device-related adverse events.

Conclusions: Non-rigid lumbar belts for subacute or recurrent non-specific low back pain appear to be effective treatment for chronic and recurrent nsLBP, and can lead to rapid and sustained improvements in pain and functional disability. Increased use of lumbar belts may help to reduce pharmacological treatments for nsLBP, especially NSAIDs.

REFERENCES: [1] World Health Organization. Low back pain. (accessed Nov 4, 2024).

[2] da C Menezes Costa L, Maher CG, Hancock MJ, McAuley JH, Herbert RD, Costa LOP. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ 2012; 184 : E613-624.

[3] da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of recurrence of low back pain: A systematic review. J Orthop Sports Phys Ther 2017; 47 : 305–13.

[4] Stubbs B, Koyanagi A, Thompson T, et al. The epidemiology of back pain and its relationship with depression, psychosis, anxiety, sleep disturbances, and stress sensitivity: Data from 43 low- and middle-income countries. Gen Hosp Psychiatry 2016; 43 : 63–70.

Acknowledgments: NIL.

Disclosure of Interests: LAURENT GRANGE received fees from the sponsor for their participation in the scientific committee of the clinical investigation, Paul CALMELS received fees from the sponsor for their participation in the scientific committee of the clinical investigation, Yves-Marie Pers: None declared, GUILLAUME LAUSTRIAT: None declared, Valérie Wieczorek: None declared, Nassima Saih: None declared, Mathieu De-Seze: None declared, Christelle Nguyen: None declared, Camille Daste: None declared, Isabelle Fayolle-Minon: None declared, Emmanuel Coudeyre: None declared, François Rannou received fees from the sponsor for their participation in the scientific committee of the clinical investigation.