Degenerative ScoliosisPhase 3BRASCONCT06774898
Spinal Bracing in Adults With Painful Degenerative Scoliosis: a Randomized Controlled Open Trial
A Phase 3 study testing Custom-molded lumbar-sacral orthosis in people with Degenerative Scoliosis and Scoliosis Idiopathic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Degenerative Scoliosis, Scoliosis Idiopathic, Thoracolumbar Scoliosis
- What is being tested?
- Custom-molded lumbar-sacral orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
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- Cognitive disorders,
- People under tutorship or curatorship,
- Protected adults, and
- Patients on AME (state medical aid),
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
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, 75014
Christelle Nguyen, MD, PhD, 01 58 41 29 45 ext. +33, christelle.nguyen2@aphp.fr
François Rannou, MD, PhD, 01 58 41 25 35 ext. +33, françois.rannou@aphp.fr
About this study
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.
Read the 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.
- Being tested
- Custom-molded lumbar-sacral orthosis, Usual Care
- Keywords
- Scoliosis, Low back pain, Spine, Bracing
- Medical subject headings
- Scoliosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-molded lumbar-sacral orthosisDevice
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 CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A : A custom-molded lumbar-sacral orthosis | Experimental | Not described Receives: Device: Custom-molded lumbar-sacral orthosis; Other: Usual Care |
| Arm B : a standardized prescription of 20 outpatient physiotherapy sessions | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after randomization
Secondary outcomes (6)
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)
Measured: 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,
Measured: 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,
Measured: 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
Measured: 12 and 24 months
Spine surgery
Percentage of participants who self-report spine surgery at 24 months
Measured: 24 months
Cost-utility ratio
Estimated total costs and incremental cost-utility ratio at 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ScoliosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774898
- Sponsor's protocol ID
- APHP230815
- Acronym
- BRASCO
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Bracing in Adults With Painful Degenerative Scoliosis: a Randomized Controlled Open Trial
- ClinicalTrials.gov ID
- NCT06774898
- Acronym / sponsor ID
- BRASCO / APHP230815
- Keywords
- Scoliosis, Low back pain, Spine, Bracing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : A custom-molded lumbar-sacral orthosis | Experimental | Device: Custom-molded lumbar-sacral orthosis, Other: Usual Care |
| Arm B : a standardized prescription of 20 outpatient physiotherapy sessions | No intervention | – |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-molded lumbar-sacral orthosisA 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). | Device | Arm A : A custom-molded lumbar-sacral orthosis |
| Usual CareUsual 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 | Other | Arm A : A custom-molded lumbar-sacral orthosis |
Primary outcome
Low back pain intensity
Time frame: 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
6 secondary outcomes
Low back pain intensity
Time frame: 12 and 24 months after randomization
Spine-specific activity limitations
Time frame: 6,12 and 24 months
Health-related quality of life
Time frame: 6,12 and 24 months
Progression of the lumbar curve
Time frame: 12 and 24 months
Spine surgery
Time frame: 24 months
Cost-utility ratio
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Custom-molded lumbar-sacral orthosis in people with Degenerative Scoliosis and Scoliosis Idiopathic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle NGUYEN, MD, PhD (01 58 41 29 95 ext. +33, christelle.nguyen2@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain intensity (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.