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Набор скоро начнётся NCT07460011

Effects of Pain Neuroscience Education on Pain, Kinesiophobia in Patients With Non Specific Low Back Pain

Без фазы С лечением Non Specific 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: Core stabilization exercises, Pain neuroscience education + core stabilization.
Кому может быть актуально
Состояния в реестре: Non Specific Low Back Pain. Базовые параметры: 20 лет — 55 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
Пакистан
Следующий шаг
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Обзор

Chronic non-specific low back pain (NSLBP) is a highly prevalent musculoskeletal condition and a leading cause of disability worldwide. Psychological factors such as fear-avoidance beliefs and kinesiophobia significantly contribute to pain chronicity, reduced physical activity, and functional limitations. Pain Neuroscience Education (PNE) is a biopsychosocial educational approach designed to reconceptualize pain as a protective output of the nervous system rather than solely a marker of tissue damage. This randomized controlled trial aims to determine the effect of Pain Neuroscience Education combined with Core Stabilization Exercises on pain intensity and kinesiophobia in patients with chronic non-specific low back pain. A total of 62 participants aged 20-55 years with mechanical low back pain lasting ≥3 months will be randomly allocated into two groups: (1) Core Stabilization Exercises plus PNE (experimental group) and (2) Core Stabilization Exercises alone (control group). The intervention duration will be four weeks, with three sessions per week. Primary outcomes include pain intensity measured by the Numeric Pain Rating Scale (NPRS) and kinesiophobia measured using the Fear-Avoidance Beliefs Questionnaire (FABQ). Assessments will be conducted at baseline and post-intervention. The study hypothesizes that the addition of PNE will produce greater reductions in fear-avoidance beliefs and pain intensity compared to exercise therapy alone.

Подробное описание

Chronic non-specific low back pain (NSLBP) accounts for approximately 85-90% of low back pain cases and is a major contributor to global disability, often persisting beyond three months without a clearly identifiable pathological cause. In addition to physical impairments, psychosocial factors such as catastrophizing, stress, poor sleep, and fear of movement play a critical role in pain chronicity and functional limitation. Traditional physiotherapy management focuses primarily on biomechanical correction and muscle strengthening; however, contemporary evidence supports a biopsychosocial model addressing cognitive and emotional contributors to pain. Pain Neuroscience Education (PNE) is an evidence-based intervention that educates patients about central sensitization, neuroplasticity, and the multidimensional nature of pain to reduce maladaptive beliefs and kinesiophobia. This single-blinded, parallel-group randomized controlled trial will enroll 62 participants aged 20-55 years diagnosed with chronic mechanical NSLBP and randomly allocate them to either an experimental group receiving Core Stabilization Exercises combined with weekly structured PNE sessions or a control group receiving Core Stabilization Exercises alone for four weeks. Both groups will receive standard physiotherapy modalities as required. Primary outcomes include pain intensity measured by the Numeric Pain Rating Scale (NPRS) and kinesiophobia measured using the Fear-Avoidance Beliefs Questionnaire (FABQ), assessed at baseline and post-intervention. Data will be analyzed using appropriate parametric tests with statistical significance set at p \< 0.05. The study aims to determine whether integrating biopsychosocial education into conventional physiotherapy enhances psychological and clinical outcomes in patients with chronic NSLBP and supports long-term functional recovery.

Вмешательства

  • Другое Core stabilization exercises
    The control group participated in an exercise program which was founded on the principle of FITT. The participants attended 3 sessions a week in a span of four weeks. The sessions were 45 minutes long and occurred at an intermediate intensity, 10 reps per set. In the case of the intervention group, the hot pack application was applied to the area of pain followed by 10 minutes of trans-cutaneous electrical nerve stimulation (TENS) and maitland's grade I and II postero-anterior glide to manage pa
  • Другое Pain neuroscience education + core stabilization
    The intervention group met thrice a week in the course of four weeks as the FITT principle dictates. All sessions took 45 minutes and were moderate in their intensity with 10 repetitions per set. The initial treatment was a 10 minutes hot pack application and a 10 minutes trans-cutaneous electrical nerve stimulation (TENS). In addition to these modalities, participants engaged in an organized program of core stabilization exercises and maitland's grade I and II postero-anterior glide to manage p

Первичные конечные точки

  • Pain intensity [Срок оценки: 4weeks]
Вторичные конечные точки (1)
  • Kinesiophobia [Срок оценки: 4week]

Критерии участия

Критерии включения

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Participants included in this study were male and female patients aged between 20 and 55 years diagnosed with chronic non-specific low back pain of mechanical origin lasting three months or more.

Individuals experiencing pain localized between the costal margin and gluteal folds without radiating symptoms or specific pathological causes were considered eligible.

Participants with low back pain that has persisted for more than three months reported pain intensity of greater than three months.

The study will involve those who have mechanical low back pain, which is defined as pain that is impacted by posture, movement, and physical activity but does not have a specific cause

Критерии исключения

  • Participants with a history of spinal fractures, previous spine injury, malignant tumors, spondylolisthesis, or spondylolysis were excluded from this study.

The conditions associated with structural instability, neurological involvement, or serious underlying pathology.

Individuals with a history of malignant tumors involving the spine were excluded because cancer-related pain.

Pregnant women were also excluded from the study due to physiological, hormonal, and bio-mechanical changes that occur during pregnancy, which may alter spinal loading, pain perception, and movement patterns

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

Пакистан · 1 центр
  • Ghurki trust and teaching hospital — Lahore

Идентификаторы

NCT: NCT07460011 · Dpt/ERB/49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗