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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

February 2, 2025

Primary Completion Date

August 1, 2027

Study Completion Date

February 2, 2029

Conditions
Degenerative ScoliosisScoliosis IdiopathicThoracolumbar Scoliosis
Interventions
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

Trial Locations (1)

75014

Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER