NCT06774898

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
49mo left

Started Sep 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

January 9, 2025

Last Update Submit

April 27, 2026

Conditions

Degenerative ScoliosisScoliosis IdiopathicThoracolumbar Scoliosis

Keywords

ScoliosisLow back painSpineBracing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Low back pain intensity

    12 and 24 months after randomization

  • Spine-specific activity limitations

    6,12 and 24 months

  • Health-related quality of life

    6,12 and 24 months

  • Progression of the lumbar curve

    12 and 24 months

  • Spine surgery

    24 months

  • +1 more secondary outcomes

Study Arms (2)

Arm A : A custom-molded lumbar-sacral orthosis

EXPERIMENTAL
Device: Custom-molded lumbar-sacral orthosisOther: Usual Care

Arm B : a standardized prescription of 20 outpatient physiotherapy sessions

NO INTERVENTION

Interventions

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).

Arm A : A custom-molded lumbar-sacral orthosis
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

Arm A : A custom-molded lumbar-sacral orthosis

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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 Region, 75014, France

Location

MeSH Terms

Conditions

ScoliosisLow Back Pain

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Christelle NGUYEN, MD, PhD

CONTACT

01 58 41 29 95christelle.nguyen2@aphp.fr

Valérie PLENCE, Msc

CONTACT

01 58 41 11 78valerie.plence-fauroux@aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 14, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)