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Идёт набор NCT07211464

Acceptance and Commitment Therapy Plus Exercise for Older People With Chronic Low-back Pain: A Pragmatic Cluster Randomised Controlled Trial

Без фазы С лечением Chronic Low-back Pain (cLBP)

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: Acceptance and commitment therapy (ACT), back exercise, back care education.
Кому может быть актуально
Состояния в реестре: Chronic Low-back Pain (cLBP). Базовые параметры: от 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
Гонконг
Следующий шаг
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Обзор

Low back pain (LBP) is the fifth-most common disorder among older adults 60 years or older. The prevalence of LBP increases with age, with the highest prevalence occurring at 85 years old. Because many older individuals face various age-related life challenges (e.g., comorbidities, financial difficulties, and bereavement), the addition of chronic LBP (CLBP) to existing stressors may worsen their physical and psychological well-being. Unfortunately, CLBP is difficult to manage and is refractory to many existing treatments. Physiotherapy treatments alone show only modest improvements in LBP or LBP-related disability. Recent research has shown that proper pain self-management is crucial to reduce pain and disability in individuals with CLBP. Acceptance and commitment therapy (ACT), a new mindfulness-based therapy, has been suggested for chronic pain management. ACT improves an individual's psychological flexibility, by improving their openness, awareness, and acceptance of the present moment (including pain). Combining ACT and exercise classes has the potential to improve the latter treatment's efficacy. Our recent pragmatic pilot, 2-arm cluster randomised controlled trial (RCT) on 40 older adults with CLBP revealed that eight weeks of ACT plus exercise and an 8-week back care education plus exercise program (control group) were safe, feasible, and well accepted by participants in elderly community centres. Moreover, compared to the control group, the ACT-plus-exercise group showed significantly greater improvements in pain intensity, LBP-related disability, health-related quality of life (HRQOL), and psychological flexibility immediately after treatment. These promising preliminary findings indicate that a fully powered clinical trial is warranted.

Подробное описание

Building on our pilot study, we aim to conduct a pragmatic definitive cluster RCT in multiple elderly community centres to validate our findings immediately post-treatment and to explore its potential beneficial effects 3 and 6 months after treatment. Additionally, we will conduct a mediation analysis to explore potential mediation effects of psychological flexibility on the association between post-treatment changes in LBP-related disability and the corresponding changes in HRQOL in older adults with CLBP. Collectively, the project's results have the potential to help clinicians find a novel pragmatic approach to empower community-dwelling older adults to self-manage their CLBP.

Вмешательства

  • Поведенческое Acceptance and commitment therapy (ACT)
    Each 1.5-hour session will consist of a 1-hour ACT intervention and 30 minutes of exercise training. The ACT group was led by a trained ACT counsellor and a trained exercise trainer.
  • Поведенческое back exercise
    30-minute exercise class
  • Поведенческое back care education
    1-hour interactive lesson on back care

Первичные конечные точки

  • Change in Pain intensity [Срок оценки: Baseline, immediately after treatment, at the 3- and 6-month follow-ups]
Вторичные конечные точки (5)
  • Change in Pain-related disability [Срок оценки: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups]
  • Change in Psychological flexibility [Срок оценки: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups]
  • Change in HRQOL [Срок оценки: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups]
  • Change in Psychological factors [Срок оценки: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups]
  • Change in falling risk [Срок оценки: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups]

Критерии участия

Критерии включения

  • aged 60 or above
  • have had non-specific LBP in or near the lumbosacral spine, with or without leg pain, that lasts for at least 3 months in the last 12 months
  • Average pain intensity (in the past week) ≥ 4 on a scale of 0 to 10
  • must have sought some healthcare professional treatments for CLBP in the last 12 months
  • have an adequate level of proficiency in Chinese
  • Mini-Mental Status Examination (MMSE) scores: 23 or above

Критерии исключения

  • People with malignant pain or lumbar spinal stenosis, confirmed dementia, severe cognitive impairment, or serious psychiatric or psychological disorders that may hinder their study participation will be excluded
  • Individuals with Mini-Mental Status Examination (MMSE) scores below 23

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
Профилактика

Центры проведения

Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07211464 · HSEARS20241101005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗