Spinal Bracing in Adults With Painful Degenerative Scoliosis: a Randomized Controlled Open Trial
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-75
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Custom-molded lumbar-sacral orthosis
- Usual Care
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov