Spinal Bracing in Adults With Painful Degenerative Scoliosis: a Randomized Controlled Open Trial (BRASCO)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Scoliosis Idiopathic; Degenerative Scoliosis; Thoracolumbar Scoliosis
• Intervention / Treatment: Device: Custom-molded lumbar-sacral orthosis; Other: Usual Care

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 Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Christelle NGUYEN, MD, PhD; Phone Number: +33 01 58 41 29 95; Email: christelle.nguyen2@aphp.fr
• Study Contact Backup: Name: Valérie PLENCE, Msc; Phone Number: +33 01 58 41 11 78; Email: valerie.plence-fauroux@aphp.fr

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
      • Contact: Christelle Nguyen, MD, PhD; Phone Number: +33 01 58 41 29 45; Email: christelle.nguyen2@aphp.fr
      • Contact: François Rannou, MD, PhD; Phone Number: +33 01 58 41 25 35; Email: françois.rannou@aphp.fr
      • Principal Investigator: Christelle NGUYEN, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A : A custom-molded lumbar-sacral orthosis	Device: Custom-molded lumbar-sacral orthosis; A custom-molded lumbar-sacral orthosis made according to the Vésinet method associated with measures designed to enhance adherence based on goal-setting techniques (i.e. personalized advice, self-determination of the wearing time, hotline) techniques and monitoring of adherence using a temperature sensor chip to provide feedbacks to participants on the wearing time at follow-up visits, and usual care (i.e. a standardized prescription of 20 outpatient physiotherapy sessions including active self-correction, spinal muscle strengthening, spine and lower limb stretching and learning of home-based exercises).; Other: Usual Care; Usual care consisting in a standardized prescription of 20 outpatient physiotherapy sessions including active self-correction, spinal muscle strengthening, spine and lower limb stretching and learning of home-based exercises
No Intervention: Arm B : a standardized prescription of 20 outpatient physiotherapy sessions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low back pain intensity	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)	12 and 24 months after randomization
Spine-specific activity limitations	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,	6,12 and 24 months
Health-related quality of life	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,	6,12 and 24 months
Progression of the lumbar curve	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	12 and 24 months
Spine surgery	Percentage of participants who self-report spine surgery at 24 months	24 months
Cost-utility ratio	Estimated total costs and incremental cost-utility ratio at 24 months	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Low back pain; Scoliosis; Spine; Bracing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Back Pain; Spinal Curvatures; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Scoliosis
• Other Study ID Numbers: APHP230815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No