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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a special back brace, called a custom-molded lumbar-sacral orthosis, can help adults with painful degenerative scoliosis manage their low back pain. Scoliosis is a condition where the spine curves abnormally, and this study will compare the effectiveness of the brace in addition to regular care for people suffering from this condition. The main goal is to see if participants experience less pain after six months of wearing the brace.

To be eligible for this study, participants need to be between 40 and 75 years old and have a specific type of scoliosis that has been diagnosed recently, along with significant low back pain that has lasted for more than three months. However, certain conditions, like having had previous spine surgery or other serious health issues, may prevent someone from participating. If someone decides to join the study, they can expect regular check-ins and assessments to see how their pain levels change over the course of six months while using the brace. This trial is not yet recruiting participants, but it aims to provide valuable insights into managing back pain for those with degenerative scoliosis.

Gender

ALL

Eligibility criteria

• 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 women