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Идёт набор NCT06620133

Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial

Без фазы С лечением Chronic Low Back Pain (Non-specific, Uncomplicated)

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: Pain education and patient-led goal setting, Guideline-based written advice.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain (Non-specific, Uncomplicated). 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
Австралия
Следующий шаг
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Официальное название

The Effect of Pain Education and Patient-led Goal Setting Compared to Guideline-based Written Information on Pain and Disability in Adults With Chronic Low Back Pain: a Randomised Controlled Trial

Обзор

The goal of this clinical trial is to investigate the effectiveness of two treatments for adults with chronic low back pain. The main question this study seeks to answer is "In adults with chronic low back pain, what is the effectiveness of pain education and patient-led goal setting compared to guideline-based written advice on reducing pain intensity and disability?". A total of 392 participants will be randomised into two groups: 1) pain education and patient-led goal setting or 2) guideline-based written advice. Participants randomised to the pain education and patient-led goal setting group will receive 5 sessions of 45-60 min each over 8 weeks delivered online via telehealth. Participants randomised to written advice group will receive information developed for people with chronic low back pain. Outcomes will be assessed at baseline and week 8, 26 and 52.

Вмешательства

  • Другое Pain education and patient-led goal setting
    8 week program delivered via five, up to 1-hour telehealth sessions. The sessions will be scheduled at approximately fortnightly intervals. Participants will also be prescribed approximately 30 minutes of online activities with each session. Pain education will be based on Explain Pain and the curriculum will have specified learning objectives adapted for each individual participant. Participants will access the online education curriculum through Pathwright. For patient-led goal setting, the he
  • Другое Guideline-based written advice
    Participants will receive guideline-based written information for the management of chronic low back pain. This will include information about the prognosis of low back pain and treatment options to consider.

Первичные конечные точки

  • Pain intensity [Срок оценки: Week 26 post-randomisation]
  • Disability [Срок оценки: Week 26 post-randomisation]
Вторичные конечные точки (12)
  • Pain intensity [Срок оценки: Weeks 8 and 52 post-randomisation]
  • Disability [Срок оценки: Weeks 8 and 52 post-randomisation]
  • Pain self-efficacy [Срок оценки: Weeks 8, 26 and 52 post-randomisation]
  • Back beliefs [Срок оценки: Weeks 8, 26 and 52 post-randomisation]
  • Kinesiophobia [Срок оценки: Weeks 8, 26 and 52 post-randomisation]
  • EuroQol 5-Dimension 5-Level (EQ-5D-5L) [Срок оценки: Weeks 8, 26 and 52 post-randomisation]
  • Daily step count [Срок оценки: Week 8 post-randomisation]
  • Light intensity physical activity [Срок оценки: Week 8 post-randomisation]
  • Moderate-vigorous intensity physical activity [Срок оценки: Week 8 post-randomisation]
  • Sedentary time [Срок оценки: Week 8 post-randomisation]
  • Subjective physical activity levels [Срок оценки: Weeks 8, 26 and 52 post-randomisation]
  • Lifestyle risk factors [Срок оценки: Weeks 8, 26 and 52 post-randomisation]

Критерии участия

Критерии включения

  • Low back pain of at least 3 months duration
  • physically inactive (less than or equal to 150min/week moderate intensity physical activity; 75 min/week vigorous activity, or some combination of the two)
  • no known contraindication(s) to performing physical activity
  • English language proficiency
  • access to internet

Критерии исключения

  • physically active (more than 150min/week moderate intensity physical activity, 75 min/week vigorous activity, or some combination of the two)
  • known contraindication(s) to performing physical activity
  • known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder)
  • scheduled for major surgery during the treatment or follow-up period

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
Открытое
Основная цель
Лечение

Центры проведения

Австралия · 1 центр
  • Neuroscience Research Australia — Sydney

Публикации

  • Gardner T, Refshauge K, McAuley J, Hubscher M, Goodall S, Smith L. Combined education and patient-led goal setting intervention reduced chronic low back pain disability and intensity at 12 months: a randomised controlled trial. Br J Sports Med. 2019 Nov;53(22):1424-1431. doi: 10.1136/bjsports-2018-100080. Epub 2019 Feb 26. PMID 30808666

Идентификаторы

NCT: NCT06620133 · CAPACITY trial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗