Health TrialsbyHealthPanel

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

ConditionsDegenerative ScoliosisScoliosis IdiopathicThoracolumbar Scoliosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-75
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Custom-molded lumbar-sacral orthosis

    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

    Other intervention

    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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Arm A : A custom-molded lumbar-sacral orthosisExperimental treatment 2 interventions
Group B: Arm B : a standardized prescription of 20 outpatient physiotherapy sessionsNo intervention 0 interventions

Trial outcomes

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

Time frame
6 months after randomization

Secondary outcomes

1

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)

Time frame
12 and 24 months after randomization
2

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,

Time frame
6,12 and 24 months
3

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,

Time frame
6,12 and 24 months
4

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

Time frame
12 and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: