Spinal Bracing in Adults With Painful Degenerative Scoliosis: a Randomized Controlled Open Trial (NCT06774898) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Spinal Bracing in Adults With Painful Degenerative Scoliosis: a Randomized Controlled Open Trial
France130 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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