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Набор скоро начнётся NCT07307859

Pain Neuroscience Education Combined With Lumbar Stabilization Exercises on Disability and Kinesiophobia Among Patients With Chronic Low Back Pain

Без фазы С лечением Chronic Low Back Pain

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: Experimental Group - Lumbar Stabilization Exercises + PNE, Control Group - Lumbar Stabilization Exercises Only.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain. Базовые параметры: 25 лет — 50 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Pain Neuroscience Education Combined With Lumbar Stabilization Exercises on Disability and Kinesiophobia Among Patients With Chronic Low Back Pain

Обзор

This study will investigate the effect of adding Pain Neuroscience Education (PNE) to a standard lumbar stabilization exercise program on disability and kinesiophobia among patients with chronic low back pain in the Gaza Strip. Participants will be randomly assigned into two groups: Control group - will receive lumbar stabilization exercises only. Experimental group - will receive lumbar stabilization exercises in addition to PNE delivered once weekly for 8 sessions. Both groups will undergo an 8-week intervention, and outcome measures will be collected at baseline, post-intervention (8 weeks), and at a follow-up assessment (16 weeks) to evaluate the persistence of treatment effects. It is expected that the experimental group will show greater improvements in disability and kinesiophobia compared with the control group, indicating that integrating PNE with stabilization exercises may provide enhanced and sustained benefits for patients with chronic low back pain.

Подробное описание

This study will explore whether integrating Pain Neuroscience Education (PNE) with a lumbar stabilization exercise program can produce superior clinical outcomes for individuals with chronic low back pain. The intervention will be delivered over eight weeks, with both groups participating in supervised lumbar stabilization sessions. The experimental group will additionally receive weekly PNE sessions designed to improve pain understanding, modify unhelpful beliefs, and reduce fear-avoidance behaviors.

PNE sessions will focus on explaining the neurophysiological mechanisms of chronic pain, emphasizing concepts such as central sensitization, the protective nature of pain, and the role of thoughts, emotions, and movement in pain modulation. The lumbar stabilization exercises will aim to improve trunk control, enhance spinal stability, and promote functional movement patterns.

Participants will be assessed at baseline, after completion of the intervention period, and again at a later follow-up to examine the sustainability of treatment effects. The study is expected to provide evidence on whether combining educational and physical interventions yields greater improvements in disability and kinesiophobia compared with stabilization exercises alone. This information may support future clinical decision-making and contribute to improving physiotherapy services for patients with chronic low back pain in the Gaza Strip.

Вмешательства

  • Другое Experimental Group - Lumbar Stabilization Exercises + PNE
    Experimental Group - Lumbar Stabilization Exercises + PNE 1. Lumbar Stabilization Exercises (LSE) Frequency: 3 supervised sessions per week for 8 weeks → Total 24 supervised LSE sessions Session duration: 45-60 minutes Structure each session: Warm-up (5-10 min) Core stabilization program (30-40 min) Cool-down (5-10 min) Progression: Exercises will advance weekly from basic motor control to high-level functional stabilization (details below). Home program: 1 a
  • Другое Control Group - Lumbar Stabilization Exercises Only
    Lumbar Stabilization Exercises (LSE) Frequency: 3 supervised sessions per week for 8 weeks → Total 24 supervised LSE sessions Session duration: 45-60 minutes Structure: Identical warm-up, core program, and cool-down as the experimental group. Progression: Identical 8-week exercise progression. Home program: 1 basic LSE home session weekly (same as experimental group). Communication: Therapists will not provide pain education or discuss pain science concepts. Adherence: Attendance logs an

Первичные конечные точки

  • Oswestry Disability Index [Срок оценки: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).]
  • Tampa Scale for Kinesiophobia (TSK) [Срок оценки: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).]
Вторичные конечные точки (1)
  • Visual Analog Scale (VAS) [Срок оценки: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).]

Критерии участия

Критерии включения

  • Adults aged 25to 50 years.
  • CLBP lasting for more than 12 weeks.

Критерии исключения

  • History of spinal surgery or fractures.
  • Presence of neurological problems.
  • Inflammatory conditions, including radiculopathy.
  • Pregnancy.
  • Body mass index (BMI) ≥ 30.
  • Chronic systemic diseases or conditions requiring regular use of strong analgesics or opioids, which may interfere with intervention outcomes.
  • Significant visual or hearing impairments.

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
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07307859 · Al Azhar University , Gaza

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗