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

Phase 3

Not yet recruiting

• Conditions: Degenerative Scoliosis; Scoliosis Idiopathic; Thoracolumbar Scoliosis

• Registration Number: NCT06774898
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-02-02
• Primary Completion: 2027-08-01
• Study Completion: 2029-02-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Low back pain intensity	6 months after randomization	Mean variation from baseline in low back pain intensity at 6 months after randomization, using a self-adminitred 11-point numeric rating scale

Secondary Outcome Measures

Name	Time	Method
Spine-specific activity limitations	6,12 and 24 months	Mean variation in spine-specific activity limitations using the self-administered Oswestry Disability Index (ODI, 0 no limitations and 100, maximal limitations) at 6, 12 and 24 months,
Cost-utility ratio	24 months	Estimated total costs and incremental cost-utility ratio at 24 months
Low back pain intensity	12 and 24 months after randomization	Mean variation from baseline in low back pain intensity at 12 and 24 months after randomization, using a self-adminitred 11-point numeric rating scale (0, no pain and 100, maximal pain in 10-point increments)
Health-related quality of life	6,12 and 24 months	Mean variation in health-related quality of life using the self-administered EQ-5D-5L questionnaire (1, having no problems and 5, having extreme problems) at 6, 12 and 24 months,
Progression of the lumbar curve	12 and 24 months	Percentage of participants with a progression of the lumbar curve, as measured by the Cobb angle, greater than 5° on an EOS® full-spine X-ray standardized posteroanterior X-ray in standing, weight-bearing position (EOS® full-spine X-ray system) at 12 and 24 months
Spine surgery	24 months	Percentage of participants who self-report spine surgery at 24 months

Trial Locations

Locations (1)

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, France