Meditation for Older Adults With Chronic Low Back Pain

Официальное название

Mindfulness-based Meditation for Older Adults With Chronic Low Back Pain Based on the Gut-brain Axis: A Pilot Randomized Controlled Trial

Обзор

This pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. This study aims to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the MBM intervention on the host Gut-Brain Axis (GBA).

Подробное описание

Aim 1: to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain.

Hypothesis: We hypothesize that our active mindfulness-based meditation intervention will be feasible and acceptable to community-dwelling older adults with chronic low back pain and improve pain and symptoms to a greater extent than older adults randomized to a sham mindfulness-based meditation group.

Aim 2: to test the effect of the mindfulness-based meditation intervention on the host Gut-Brain Axis (GBA).

Hypothesis: We hypothesize that older adults randomized to the active mindfulness-based meditation intervention will have significantly improved compositional patterns and functional profiles of gut microbiota and increased pain-related cortical response measured by functional near-infrared spectroscopy (fNIRS) to a greater extent than older adults randomized to the sham mindfulness-based meditation group at 2-weeks post-intervention, and 8-weeks follow up.

Вмешательства

• Поведенческое Active MBM
  The MBM is designed to be applied for 20 minutes per session daily for two weeks. The recording will instruct participants to close their eyes, connect to the openness of one's minds, and mindfully maintain and deepen the connection through breathing with more openness and awareness. The MBM intervention will include three recordings that gradually take the participant into a more profound meditation practice. Participants will be instructed to listen to Meditation 1 for the first three days of
• Поведенческое Sham MBM
  The sham MBM intervention was also recorded. The sham recording will instruct participants to relax and take deep breaths every 3 minutes without the specific mindfulness-based instructions (e.g., practicing mindful attention to the breath in a non-evaluative manner). All other aspects of the sham MBM intervention (e.g., body position, time spent listening to instructions, eyes closed) will match the active MBM.

Первичные конечные точки

• Change in pain intensity and interference [Срок оценки: Baseline and 2 weeks and 8 weeks]

Вторичные конечные точки (9)

• Change in pain sensitivities [Срок оценки: Baseline and 2 weeks and 8 weeks]
• Change in pain modulation [Срок оценки: Baseline and 2 weeks and 8 weeks]
• Change in chronic pain self-efficacy [Срок оценки: Baseline and 2 weeks and 8 weeks]
• Change in anxiety [Срок оценки: Baseline and 2 weeks and 8 weeks]
• Change in depression [Срок оценки: Baseline and 2 weeks and 8 weeks]
• Change in fatigue [Срок оценки: Baseline and 2 weeks and 8 weeks]
• Change in sleep disturbance [Срок оценки: Baseline and 2 weeks and 8 weeks]
• Change in pain-related cortical response [Срок оценки: Baseline and 2 weeks and 8 weeks]
• Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut [Срок оценки: Baseline and 2 weeks and 8 weeks]

Критерии участия

Критерии включения

• aged 50 years older
• intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
• experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\])
• able to speak and read English
• not intent to change medication regimens for pain throughout the trial

Критерии исключения

• serious underlying illness (e.g., malignant neoplasms, bloodborne illness, low blood platelet count, been in chemotherapy)
• psychosis
• function limitation precluded the meditation practice
• participated meditation program before
• no access to the internet

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

Поддерживающая терапия

Центры проведения

США · 1 центр

• Florida State University — Tallahassee

Идентификаторы

NCT: NCT06384001 · STUDY00004032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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