Clinical trial NCT06774898: Spinal Bracing in Adults with Painful Degenerative Scoliosis: a Randomized Controlled Open Trial
Official title: Spinal Bracing in Adults with Painful Degenerative Scoliosis: a Randomized Controlled Open Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Degenerative Scoliosis
Scoliosis Idiopathic
Thoracolumbar Scoliosis
Keywords: Scoliosis
Low back pain
Spine
Bracing
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Adult degenerative scoliosis is a spinal deformity that appears during adulthood, usually after 50 years, on a previous aligned spine or on an idiopathic scoliosis, due to a cascade of degenerative changes. Adult degenerative scoliosis is more prevalent in women than in men and affects up to 40% of adults aged 65 years and older. Overall, 60 to 80% of patients with adult degenerative scoliosis suffer from low back pain. Apart from analgesics, spinal glucocorticoid injections and physiotherapy, the 2 therapeutic options are bracing and spinal surgery.

Recent literature has suggested better outcomes with surgery than with conservative care. However, the level of evidence was low and the use of bracing in the conservative approach was not specifically evaluated. Therefore, good quality studies assessing bracing efficacy in adult degenerative scoliosis are lacking, explaining in part why many physicians do not offer it as a first-line therapeutic option and instead refer patients to surgery. In a retrospective study of 38 patients with adult degenerative scoliosis, the use of a custom-molded lumbar-sacral orthosis, for a minimum of 6h/d, was associated with a reduction in curve progression as measured with the Cobb angle and with an improvement in pain and activity limitations, at 5-year follow-up.

We hypothesize that a custom-molded lumbar-sacral orthosis as an add-on therapy to usual care (i.e. a standardized prescription of 20 outpatient physiotherapy sessions) could decrease symptoms in people with painful adult degenerative scoliosis as compared to usual care.

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

Primary outcomes:
measure: Low back pain intensity
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Low back pain intensity
timeFrame: 12 and 24 months after randomization
measure: Spine-specific activity limitations
timeFrame: 6,12 and 24 months
measure: Health-related quality of life
timeFrame: 6,12 and 24 months
measure: Progression of the lumbar curve
timeFrame: 12 and 24 months
measure: Spine surgery
timeFrame: 24 months
measure: Cost-utility ratio
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
state: Île-de-France
Study officials:
References: