Mindfulness-based Meditation for Older Adults With Chronic Low Back Pain Based on the Gut-brain Axis: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in pain intensity and interference
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •serious underlying illness (e.g., malignant neoplasms, bloodborne illness, low blood platelet count, been in chemotherapy)
- •function limitation precluded the meditation practice
- •participated meditation program before
- •no access to the internet
结局指标
主要结局
Change in pain intensity and interference
时间窗: Baseline and 2 weeks and 8 weeks
Pain Inventory (BPI) will be used to assess the multidimensional aspects of pain, its location, intensity, and interference. A higher score indicated higher pain intensity with 0 indicating no pain and 10 indicating the worst pain. A higher score of pain interference means daily functions are more impacted by pain, and 0 indicates no pain interference, and 10 means the worst pain interference.
次要结局
- Change in pain sensitivities(Baseline and 2 weeks and 8 weeks)
- Change in pain modulation(Baseline and 2 weeks and 8 weeks)
- Change in chronic pain self-efficacy(Baseline and 2 weeks and 8 weeks)
- Change in anxiety(Baseline and 2 weeks and 8 weeks)
- Change in depression(Baseline and 2 weeks and 8 weeks)
- Change in fatigue(Baseline and 2 weeks and 8 weeks)
- Change in sleep disturbance(Baseline and 2 weeks and 8 weeks)
- Change in pain-related cortical response(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(Baseline and 2 weeks and 8 weeks)
- Change in pain sensitivities(Baseline and 2 weeks and 8 weeks)
- Change in pain modulation(Baseline and 2 weeks and 8 weeks)
- Change in chronic pain self-efficacy(Baseline and 2 weeks and 8 weeks)
- Change in anxiety(Baseline and 2 weeks and 8 weeks)
- Change in depression(Baseline and 2 weeks and 8 weeks)
- Change in fatigue(Baseline and 2 weeks and 8 weeks)
- Change in sleep disturbance(Baseline and 2 weeks and 8 weeks)
- Change in pain-related cortical response(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(Baseline and 2 weeks and 8 weeks)
研究者
Jie Chen, PhD, RN
Principal Investigator
Florida State University