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

Starting soon · Phase 3

Conditions studied: Degenerative Scoliosis, Scoliosis Idiopathic, Thoracolumbar Scoliosis

In brief

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 facts

Study ID

NCT06774898

Run by

Assistance Publique - Hôpitaux de Paris

People needed

130

Starts

2026-09-01

Expected to finish

2030-09-01

Last updated by the study team

2026-05-01

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 40 to 75 years,
• Degenerative thoracolumbar or lumbar scoliosis with Cobb angle for the largest curve greater than 20°on EOS® full-spine X-ray less than 1 year (this can be a de-novo scoliosis, or a degenerative scoliosis that appears on an idiopathic scoliosis), and
• Low back pain with a duration more than 3 months
• Low back pain with an intensity greater than 40 of 100 points on a self-administered numeric rating scale.
• Patient able to give written informed consent prior to participation in the study Affiliation with a mode of social security (profit or being entitled).

You may not qualify if…

• Spinal deformity secondary to a specific condition (e.g. fracture, infection, tumour, inflammatory rheumatic disease, neuromuscular disorder, genetic disorder),
• History of spine surgery,
• Morphotype and/or conditions making spinal bracing technically impossible (e.g. obesity, severe clinical sagittal and/or coronal malalignment, recent abdominal surgery etc)
• Inability to speak and/or read French language,
• Inability or refusal to wear a custom-molded lumbar-sacral orthosis,
• Patients already wearing a custom-molded lumbar-sacral orthosis,
• Cognitive disorders,
• People under tutorship or curatorship,
• Protected adults, and
• Patients on AME (state medical aid),
• Pregnant or breastfeeding women

Where it is running

• 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

Full record on ClinicalTrials.gov

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