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Набор скоро начнётся NCT07558993

Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Radiculopathy

Без фазы С лечением Radiculopathy Radiculopathy Lumbar Sciatica Disc Disease Lumbar

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: Mirror Image Spine Correction Exercises, Conservative Physiotherapy.
Кому может быть актуально
Состояния в реестре: Radiculopathy, Radiculopathy Lumbar, Sciatica, Disc Disease Lumbar. 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
ОАЭ
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Randomized, Parallel-Group, Superiority Trial of Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Nerve Root Microstructural Integrity Assessed by Diffusion Tensor Imaging in Adults With Lumbar Radiculopathy

Обзор

Lumbar radiculopathy is a common condition caused by irritation or compression of a lumbar nerve root, often resulting in radiating leg pain, numbness, weakness, and functional limitation. Conservative physiotherapy is commonly used as first-line treatment, but outcomes vary among patients. This randomized controlled trial will compare Mirror Image Spine Correction Exercises with standardized conservative physiotherapy in adults with lumbar radiculopathy. Participants will be randomly assigned to one of two treatment groups for 12 weeks. The primary outcome is lumbar nerve root microstructural integrity measured using Diffusion Tensor Imaging (DTI), including Fractional Anisotropy and other diffusion parameters. Secondary outcomes include pain intensity, disability, spinal alignment, and adverse events. The purpose of this study is to determine whether a targeted posture-correction exercise approach provides greater improvement than conventional physiotherapy.

Подробное описание

Lumbar radiculopathy is a neuromusculoskeletal disorder commonly caused by lumbar disc herniation or foraminal stenosis leading to nerve root irritation or compression. Symptoms commonly include radiating leg pain, paresthesia, weakness, altered reflexes, and reduced physical function.

Conservative physiotherapy is recommended as first-line management and may include education, graded exercise, mobility restoration, strengthening, neural mobilization, and symptom management. However, treatment response is heterogeneous, and many patients continue to experience persistent symptoms.

Most previous rehabilitation studies have relied primarily on patient-reported outcomes such as pain and disability. These measures are clinically important but may not fully reflect biological recovery of the affected nerve root.

Diffusion Tensor Imaging (DTI) is an advanced magnetic resonance imaging technique that can quantify neural tissue microstructure. Parameters such as Fractional Anisotropy (FA), Mean Diffusivity (MD), Axial Diffusivity (AD), and Radial Diffusivity (RD) may provide objective markers of nerve recovery.

Mirror Image Spine Correction Exercises are individualized posture-based exercises designed to move the trunk or pelvis opposite to identified alignment deviations. This approach may improve biomechanics, reduce abnormal loading, and decrease neural irritation.

This study is a prospective randomized, parallel-group, superiority trial. Eligible adults with unilateral lumbar radiculopathy will be randomly allocated in a 1:1 ratio to:

Mirror Image Spine Correction Exercise group Standardized Conservative Physiotherapy group Both groups will receive supervised treatment sessions three times per week for 12 weeks.

Primary Outcome:

Change in lumbar nerve root microstructural integrity measured by DTI at baseline and week 12.

Secondary Outcomes:

Pain intensity Disability (Oswestry Disability Index) Spinal alignment Safety outcomes and adverse events The study aims to determine whether Mirror Image Spine Correction Exercises produce superior clinical and imaging outcomes compared with conservative physiotherapy.

Вмешательства

  • Поведенческое Mirror Image Spine Correction Exercises
    Participants will receive an individualized supervised exercise program based on identified postural alignment deviations. Treatment will be delivered three sessions per week for 12 weeks and may include trunk and pelvic corrective movements, mobility, stabilization, and a prescribed home exercise program.
  • Поведенческое Conservative Physiotherapy
    Participants will receive standardized conservative physiotherapy three sessions per week for 12 weeks including education, graded exercise, mobility exercises, strengthening, neural mobilization, and clinically indicated adjunctive non-invasive techniques.

Первичные конечные точки

  • Lumbar Nerve Root Fractional Anisotropy [Срок оценки: Baseline and Week 12]
Вторичные конечные точки (3)
  • Pain Intensity [Срок оценки: Baseline and Week 12]
  • Spinal Alignment [Срок оценки: Baseline and Week 12]
  • Additional DTI Parameters [Срок оценки: Baseline and Week 12]

Критерии участия

Критерии включения

  • Adults aged 18 years or older. Clinical diagnosis of unilateral lumbar radiculopathy. Presence of at least two of the following: dermatomal radiating leg pain, neurological deficit, positive neural tension test.

MRI-confirmed lumbar nerve root compression or irritation consistent with symptoms.

Pain intensity of 3/10 or greater. Able to undergo MRI and Diffusion Tensor Imaging (DTI). Able to understand study procedures and provide written informed consent.

Критерии исключения

  • Previous lumbar spine surgery. Bilateral radiculopathy or unclear diagnosis. Tumor, infection, fracture, inflammatory spinal disease, or cauda equina syndrome.

Severe progressive neurological deficit requiring urgent treatment. Contraindications to MRI (pacemaker, incompatible implants, severe claustrophobia).

Recent lumbar injections or surgery. Other neurological or musculoskeletal disorders affecting outcomes. Pregnancy if MRI contraindicated by local policy. Cognitive impairment or inability to follow instructions.

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

ОАЭ · 1 центр
  • Al Qassimi Hospital — Sharjah city

Публикации

  • Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008. PMID 17445735
  • Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin. 2007 May;25(2):353-71. doi: 10.1016/j.ncl.2007.01.004. PMID 17445733

Идентификаторы

NCT: NCT07558993 · UOS-PHD-LRDTI-2026-01 · U25103971

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗