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Набор по приглашению NCT07003802

Neural Control and Mechanosensation in Spine Muscle

Без фазы С лечением Low Back Pain and Core Muscle Disc Herniation

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: Resistance exercise.
Кому может быть актуально
Состояния в реестре: Low Back Pain and Core Muscle, Disc Herniation. Базовые параметры: 18 лет — 60 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Contributions of Neural Control and Mechanosensation to Rehabilitation Induced Spine Muscle Recovery

Обзор

Low back pain (LBP) is a condition that affects a majority of the US population and is responsible for a significant proportion of health care costs and utilization. Lumbar spine muscle is compromised in LBP, and do, and do not, respond to exercise based physical therapy program depending on measurements representing activation capacity of lumbar muscle. Here, we will characterize the neurological and muscle specific features that may contribute to limited activation in an attempt to identify sources of resistance to recovery in patients with chronic disc injury and identify precision rehabilitation approaches for this complex population of individuals.

Подробное описание

Low back pain (LBP) is a complex condition that affects 65-85% of the population, and is the leading musculoskeletal condition contributing to disability in the United States. Disc injury is the most common injury and 75% of individuals undergoing surgical and rehabilitative interventions for this condition experience suboptimal or poor outcomes. These patients demonstrate disability and deficits in functional capacity, and paraspinal muscles in these individuals have been shown to be altered in volume, composition, and mechanical properties. These maladaptive changes influence the ability for the muscle to respond appropriately to rehabilitation efforts in a subgroup of individuals with chronic back pain who do not demonstrate the expected acute activation responses to exercise. While the structural and adaptive capacities of healthy muscle are well understood, pathological muscle recovery and activation deficits are less clear and may be influenced by neurogenic and/or muscle specific impairments. To address this gap in knowledge, the purpose of this trial is to compare central and peripheral origins of impaired activation in individuals with chronic disc injury who do, and do not respond to exercise. Experiment 1 will use a novel functional MRI technique and electromyographic measurements to compare responder and non-responder groups in patients with chronic lumbar disc injury undergoing standard physical therapy. Experiment 2 will compare corticomotor excitability and intracortical inhibition and facilitation between individuals who are undergoing physical therapy or surgery who do and do not respond to exercise. Experiment 3 will compare ex vivo passive and active mechanical responses, and transcriptomics from intraoperative multifidus biopsies of patients undergoing spinal surgery for chronic lumbar disc injury to evaluate muscle mechanotransduction. These experiments will elucidate the neurogenic and muscle-specific contributions to muscle adaptation in the presence of chronic lumbar spine pathology and pain.

Вмешательства

  • Поведенческое Resistance exercise
    An acute bout of a 3 minute resistance exercise will be performed using a lumbar extension exercise machine

Первичные конечные точки

  • RMS amplitude of paraspinal muscle EMG [Срок оценки: Baseline]
  • IVIM responsiveness [Срок оценки: Baseline]
  • Cortical excitability [Срок оценки: Baseline]
  • pAMPK [Срок оценки: Time of surgery/biopsy]
Вторичные конечные точки (5)
  • MEP amplitude [Срок оценки: Baseline]
  • Cortical Silent Period [Срок оценки: Baseline]
  • Short Interval Intracortical Inhibition (SICI) [Срок оценки: Baseline]
  • Short Interval Intracortical Facilitation (SICF) [Срок оценки: Baseline]
  • p-mTORS2448/total mTOR [Срок оценки: Time of surgery/biopsy]

Критерии участия

Критерии включения

  • Surgical group:
  • Individuals diagnosed with chronic disc injury (symptoms > 3 months),
  • Individuals planning to undergo a spinal surgery to address the diagnosis of chronic disc injury

Physical Therapy Group-

  • Individuals diagnosed with chronic disc injury (symptoms >3 months),
  • Individuals initiating an exercise-based physical therapy program to address the diagnosis of chronic disc injury

Healthy Control group -

  • Individuals with no history of chronic back pain (interfering pain lasting >3 months) within the past 3 years,
  • no significant spinal pathology beyond normal age-related degenerative changes

Критерии исключения

  • Surgery/Physical therapy groups-History of lumbar spine surgery
  • Diabetes
  • Neuromuscular diseases
  • Epilepsy or other seizure disorder -Healthy control group -
  • History of lumbar spine surgery
  • History of interfering pain lasting >3 months
  • Diabetes
  • Neuromuscular diseases
  • Epilepsy or other seizure disorder

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • UC San Diego — La Jolla

Идентификаторы

NCT: NCT07003802 · HD088437-06

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗