NCT06774898

Spinal Bracing in Adults with Painful Degenerative Scoliosis: a Randomized Controlled Open Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy on low back pain intensity at 6 months after randomization of a custom-molded lumbar-sacral orthosis as an add-on therapy to usual care in people with painful adult degenerative scoliosis.

Detailed description

Adult degenerative scoliosis is a spinal deformity that appears during adulthood, usually after 50 years, on a previous aligned spine or on an idiopathic scoliosis, due to a cascade of degenerative changes. Adult degenerative scoliosis is more prevalent in women than in men and affects up to 40% of adults aged 65 years and older. Overall, 60 to 80% of patients with adult degenerative scoliosis suffer from low back pain. Apart from analgesics, spinal glucocorticoid injections and physiotherapy, the 2 therapeutic options are bracing and spinal surgery. Recent literature has suggested better outcomes with surgery than with conservative care. However, the level of evidence was low and the use of bracing in the conservative approach was not specifically evaluated. Therefore, good quality studies assessing bracing efficacy in adult degenerative scoliosis are lacking, explaining in part why many physicians do not offer it as a first-line therapeutic option and instead refer patients to surgery. In a retrospective study of 38 patients with adult degenerative scoliosis, the use of a custom-molded lumbar-sacral orthosis, for a minimum of 6h/d, was associated with a reduction in curve progression as measured with the Cobb angle and with an improvement in pain and activity limitations, at 5-year follow-up. We hypothesize that a custom-molded lumbar-sacral orthosis as an add-on therapy to usual care (i.e. a standardized prescription of 20 outpatient physiotherapy sessions) could decrease symptoms in people with painful adult degenerative scoliosis as compared to usual care.

Conditions

• Degenerative Scoliosis
• Scoliosis Idiopathic
• Thoracolumbar Scoliosis

Interventions

Type	Name	Description
DEVICE	Custom-molded lumbar-sacral orthosis	A custom-molded lumbar-sacral orthosis made according to the Vésinet method associated with measures designed to enhance adherence based on goal-setting techniques (i.e. personalized advice, self-determination of the wearing time, hotline) techniques and monitoring of adherence using a temperature sensor chip to provide feedbacks to participants on the wearing time at follow-up visits, and usual care (i.e. a standardized prescription of 20 outpatient physiotherapy sessions including active self-correction, spinal muscle strengthening, spine and lower limb stretching and learning of home-based exercises).
OTHER	Usual Care	Usual care consisting in a standardized prescription of 20 outpatient physiotherapy sessions including active self-correction, spinal muscle strengthening, spine and lower limb stretching and learning of home-based exercises

Timeline

• Start date: 2025-02-02
• Primary completion: 2027-08-01
• Completion: 2029-02-02
• First posted: 2025-01-14
• Last updated: 2025-01-14

Locations

1 site across 1 country: France