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Идёт набор NCT07277517

The Effect of Integrating Pain Neuroscience Education(PNE) With Conventional Physiotherapy on Pain and Functional Disability in Patients With Acute Low Back Pain

Без фазы С лечением Acute 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: routine physiotherapy + traditional patient education, pain neuroscience education.
Кому может быть актуально
Состояния в реестре: Acute Low-back Pain. 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
Иран
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Acute low back pain is one of the most common health problems in the world. Most people experience it at least once in their lives, and although many cases improve within a few weeks, a significant number of patients continue to struggle with pain, fear of movement, stress, and reduced daily function. These psychological factors-such as catastrophizing ("my back is damaged"), fear of movement ("if I move, it gets worse"), and avoidance behaviors-can slow recovery and increase the risk of the pain becoming chronic. Pain Neuroscience Education (PNE) is a modern educational approach that teaches patients how pain actually works in the nervous system. Instead of focusing only on muscles and bones, PNE helps people understand how the brain interprets pain, why pain can persist even without serious injury, and how thoughts, emotions, and behaviors can influence the experience of pain. Research shows that PNE can reduce fear, improve movement, and help people participate better in rehabilitation-especially in chronic pain. However, there is very limited high-quality evidence about its effects in acute low back pain. The purpose of this study is to determine whether adding Pain Neuroscience Education to routine physiotherapy can improve recovery in people with acute low back pain. To do this, the investigators will conduct a single-blind randomized clinical trial with two groups of patients: Control group: Receives conventional physiotherapy, including soft-tissue mobilization and TENS, along with routine patient education about posture and back care. Intervention group: Receives the same physiotherapy plus two structured sessions of Pain Neuroscience Education, delivered individually using simple explanations, metaphors, and visual materials. Both groups will receive eight treatment sessions over four weeks. The investigators will measure several important outcomes before starting treatment and immediately after the 8th session, including: Pain intensity Functional disability Pain catastrophizing Fear-avoidance beliefs Fear of movement (kinesiophobia) The investigators' hypothesis is that patients who receive PNE in addition to routine physiotherapy will show greater reductions in pain, disability, fear, and catastrophizing compared to those receiving physiotherapy alone. If proven effective, this approach could provide a simple, low-cost, and safe addition to physiotherapy that not only reduces pain but also prevents acute low back pain from turning into a chronic condition. This could help improve patients' quality of life and reduce the economic and healthcare burden caused by low back pain.

Вмешательства

  • Другое routine physiotherapy + traditional patient education
    Conventional Physiotherapy (Control Group) Participants in the control group will receive a baseline physiotherapy protocol, administered twice weekly for four weeks (8 sessions total). Each session includes: Soft Tissue Mobilization (40 minutes): Four specific myofascial release techniques targeting the low back and pelvic muscles (e.g., transverse sliding of lumbar muscles, thoracolumbar fascia release, quadratus lumborum release, iliopsoas release). Transcutaneous Electrical Nerve Stimulat
  • Поведенческое pain neuroscience education
    The experimental group receives the same conventional physiotherapy as the control group, with the addition of PNE. This consists of two individual, face-to-face educational sessions (40-50 minutes each), delivered before the first and after the last physiotherapy session. The curriculum is based on established resources ("Explain Pain" and "Pain Neuroscience Education: Teaching People About Pain") and uses metaphors, examples, and slides to reconceptualize pain by explaining neurobiology, centr

Первичные конечные точки

  • Visual Analog Scale [Срок оценки: first session (day 1), end of 8th session (4 weeks)]
  • Oswestwry Disability Index [Срок оценки: first session (day 1), end of 8th session (4 weeks)]
Вторичные конечные точки (3)
  • Tampa Scale Of Kinesiophobia [Срок оценки: first session (day 1), end of 8th session (4 weeks)]
  • Fear Avoidance Beliefs Questionnaire [Срок оценки: first session (day 1), end of 8th session (4 weeks)]
  • Pain Catastrophizing Scale [Срок оценки: first session (day 1), end of 8th session (4 weeks)]

Критерии участия

Критерии включения

  • Adults aged 18 years and older.
  • A primary complaint of acute low back pain (defined as pain between the bottom of the ribs and the gluteal fold), with or without leg pain.
  • Pain duration of less than 6 weeks.
  • Absence of any "red flags" for serious spinal pathology (e.g., tumor, infection, fracture, cauda equina syndrome), as confirmed by an orthopedist or neurologist.

Критерии исключения

  • Low back pain lasting more than 3 months (chronic low back pain).
  • History of spinal surgery within the past 3 years.
  • Inability to read or understand Persian.
  • Diagnosed cognitive impairments.
  • Unwillingness to continue the treatment or study protocol.
  • Diagnosed rheumatic, neurological, cardiac, metabolic, or respiratory diseases.
  • Diagnosis of fibromyalgia, chronic fatigue syndrome, loss of skin sensation, or skin inflammation/swelling in the low back area.
  • Presence or emergence of any "red flag" condition.
  • Missing more than 3 consecutive treatment sessions.
  • Previous participation in Pain Neuroscience Education sessions.

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

Иран · 1 центр
  • rehabilitation facility, Iran university of medical science — Tehran

Идентификаторы

NCT: NCT07277517 · IR.IUMS.REC.1404.530

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗