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

NCT ID: NCT06774898

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-02
• Study Completion Date: 2029-02-02

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.

Conditions

Degenerative Scoliosis; Scoliosis Idiopathic; Thoracolumbar Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm A : A custom-molded lumbar-sacral orthosis

Group Type: EXPERIMENTAL

Custom-molded lumbar-sacral orthosis

Intervention Type: DEVICE

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).

Usual Care

Intervention Type: OTHER

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

Arm B : a standardized prescription of 20 outpatient physiotherapy sessions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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 Region, France

Countries

France

Central Contacts

Christelle NGUYEN, MD, PhD

Role: CONTACT

christelle.nguyen2@aphp.fr

01 58 41 29 95 ext. +33

Valérie PLENCE, Msc

Role: CONTACT

valerie.plence-fauroux@aphp.fr

01 58 41 11 78 ext. +33

Facility Contacts

Christelle Nguyen, MD, PhD

Role: primary

christelle.nguyen2@aphp.fr

01 58 41 29 45 ext. +33

François Rannou, MD, PhD

Role: backup

françois.rannou@aphp.fr

01 58 41 25 35 ext. +33

Christelle NGUYEN, MD, PhD

Role: backup

Other Identifiers

APHP230815

Identifier Type: -

Identifier Source: org_study_id