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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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-
• Другое 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

Первичные конечные точки

• Low back pain intensity [Срок оценки: 6 months after randomization]

Вторичные конечные точки (6)

• Low back pain intensity [Срок оценки: 12 and 24 months after randomization]
• Spine-specific activity limitations [Срок оценки: 6,12 and 24 months]
• Health-related quality of life [Срок оценки: 6,12 and 24 months]
• Progression of the lumbar curve [Срок оценки: 12 and 24 months]
• Spine surgery [Срок оценки: 24 months]
• Cost-utility ratio [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Ap — Paris

Идентификаторы

NCT: NCT06774898 · APHP230815

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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