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Идёт набор NCT06216288

Effect of Combined Lumbar Traction and Repetitive Back Extension Exercise on H-reflex in Lumbosacral Radiculopathy

Без фазы С лечением Lumbosacral Radiculopathy McKenzie Derangement Syndrome

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: Repeated back extension exercise (McKenzie), Mechanical traction.
Кому может быть актуально
Состояния в реестре: Lumbosacral Radiculopathy, McKenzie Derangement Syndrome. Базовые параметры: 35 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
Египет
Следующий шаг
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Официальное название

The Effects of Combined Lumbar Traction and Repeated Back Extension Exercise on H-Reflex, Pain, and Disability in Patients With Lumbosacral Radiculopathy

Обзор

The aim of the study is to investigate the effect of performing combined lumbar traction and repeated back extension exercise (McKenzie) on soleus H-reflex, pain, and disability in patients with lumbosacral radiculopathy. The main question that it aims to answer is: Does the combination of lumbar traction and back extension exercise (McKenzie) improves soleus H-reflex, pain, and function in patient with lumbosacral radiculopathy? participants will be randomized into 2 groups: one group will include repeated back extension exercise (McKenzie Approach) without mechanical traction and the other group will include the same but in combination with mechanical traction.

Подробное описание

Repeated back extension exercises as described by McKenzie from prone position has been widely suggested for patients with lumbosacral radiculopathy (LSR). It has been reported to decrease radicular symptoms which could be due to the decompression effect of this exercise on the compromised nerve root. Moreover, mechanical traction have a debatable effect on lumbosacral patients with little evidence that supports its effectiveness. Thus, the investigators hypothesize that performing a combination of lumbar traction and repeated back extension exercise will improve the soleus H-reflex, pain, and function of lumbosacral radiculopathy patients.

Вмешательства

  • Другое Repeated back extension exercise (McKenzie)
    repetitive back extension exercises in prone position with 1 minute hold on maximal back extension. 3 sets of 10 repetitions with 1 minute break between sets. The intervention was done 3 times per week for 6 weeks.
  • Устройство Mechanical traction
    The traction was applied using a 3D ActiveTrac table. This motorized split table applied static traction to the lumbar spine with the participant in a prone position. The intensity of the force of traction was 40% to 60% of the participant's body weight applied for 15 minutes. The intervention was done 3 times per week for 6 weeks.

Первичные конечные точки

  • Soleus H-reflex amplitude [Срок оценки: At baseline and 6 weeks]
  • Soleus H-reflex latency [Срок оценки: At baseline and 6 weeks]
Вторичные конечные точки (2)
  • Numerical Pain Intensity Scale [Срок оценки: At baseline and 6 weeks]
  • Oswestry Disability Index (ODI) [Срок оценки: At baseline and 6 weeks]

Критерии участия

Критерии включения

  • Patient with chronic unilateral lumbosacral radiculopathy (more than 3 months duration)
  • Age:35- 60 years
  • Both male and female
  • People with L5-S1 postero-lateral disc herniation or protrusion.
  • people with positive straight leg raise

Критерии исключения

  • Subjects with lumbosacral Surgery.
  • Subjects with stenosis or scoliosis.
  • Subjects with cardiac problem or cancer.
  • Subjects with peripheral neuropathy.
  • Subjects with upper motor neuron injury.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Ahmed ElMelhat [aelmelhat] — Cairo

Публикации

  • Al-Abdulwahab S. Back extension exercises decompress the spinal root and improve standing mobility in patients with sub-acute lumbosacral radiculopathy. Somatosens Mot Res. 2016 Sep-Dec;33(3-4):196-199. doi: 10.1080/08990220.2016.1251895. Epub 2016 Nov 13. PMID 27838950
  • Vanti C, Saccardo K, Panizzolo A, Turone L, Guccione AA, Pillastrini P. The effects of the addition of mechanical traction to physical therapy on low back pain? A systematic review with meta-analysis. Acta Orthop Traumatol Turc. 2023 Jan;57(1):3-16. doi: 10.5152/j.aott.2023.21323. PMID 36939359
  • Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26. PMID 26813755

Идентификаторы

NCT: NCT06216288 · H-reflex in Radiculopathy

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗