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Spinal Bracing in Adults with Painful Degenerative Scoliosis: a Randomized Controlled Open Trial
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-02-02
Completion Date
2029-02-02
Last Updated
2025-01-14
Healthy Volunteers
No
Interventions
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).
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
Locations (1)
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Paris, Île-de-France Region, France