Идёт набор NCT06129682

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

Без фазы С лечением Spondylolisthesis, Lumbar Region

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Self rehabilitation at home.
Кому может быть актуально: Состояния в реестре: Spondylolisthesis, Lumbar Region. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Self-rehabilitation At Home After LumbaR Arthrodesis

Обзор

Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist. The investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).

Подробное описание

Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disability after surgery : it has been showed that early rehabilitation improves lumbar pain thanks to muscle strengthening.

The design of the study is prospective,monocentric, controlled and randomized. This study compares progressive self-rehabilitation at home after lumbar arthrodesis, explained to the patient by a physiotherapist during his or her stay at the hospital and started right after surgery, versus rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment).

The primary outcome is decrease of lumbar pain at 6 weeks and 3 months after surgery. The secondary outcomes are improvement of functional abilities and improvement of pelvis and limbs ranges of motion.

Patients of both groups will be followed by surgeon and physiotherapist at 6 weeks and 3 months.

Вмешательства

Другое Self rehabilitation at home
6 week program of exercise at home of gradual intensity and duration

Первичные конечные точки

Change of lumbar pain [Срок оценки: At 6 weeks and 3 months after surgery]

Вторичные конечные точки (4)

Improvement of functional abilities [Срок оценки: At 6 weeks and 3 months after surgery]
Improvement of ranges of motion - Ely test [Срок оценки: At 6 weeks and 3 months after surgery]
Improvement of ranges of motion - Straight Leg Test [Срок оценки: At 6 weeks and 3 months after surgery]
Improvement of ranges of motion - Schober test [Срок оценки: At 6 weeks and 3 months after surgery]

Критерии участия

Критерии включения

Lumbar pain and/or nerve root pain and/or limp without any motor deficiency of the limbs, before and/or after surgery (if any motor deficiency occurs after surgery, it will be a secondary exclusion criteria)
Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)
Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and/or nerve root pain and/or limp
Return home possible after surgery
After signing consent during pre-operative visit with the surgeon