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Can a special brace ease back pain from curved spine?

NCT ID NCT06774898

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether wearing a custom-made back brace, along with standard care like physical therapy, can reduce low back pain in adults with degenerative scoliosis (a curved spine that causes pain). About 130 people aged 40 to 75 with moderate to severe pain will be randomly assigned to either the brace plus usual care or usual care alone. The main goal is to see if pain improves after 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
custom-molded lumbar-sacral orthosis (back brace)
What this could lead to
If it works, this could provide a non-surgical option to ease chronic low back pain in adults with scoliosis.
What could go wrong
This is a relatively small trial (130 people) and the brace may not reduce pain more than usual care alone. Some people may find the brace uncomfortable or difficult to wear as prescribed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

idiopathic scoliosis Low Back Pain scoliosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative scoliosis Scoliosis idiopathic Thoracolumbar scoliosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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, 75014, France

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