Home-based Mindfulness-based Meditation and Transcutaneous Auricular Vagus Nerve Stimulation for Older Adults With Low Back Pain and Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in pain intensity and interference
研究概览
简要总结
This two-arm randomized controlled trial aims to test the preliminary effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms; and the effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on the host Brain-Gut Axis.
详细描述
Primary Objective: To test the preliminary effect of home-based mindfulness-based meditation (MBM) and transcutaneous auricular vagus nerve stimulation (taVNS) on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms.
Secondary Objective(s): To test the effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on the host Brain-Gut Axis.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 50 to 85 years old
- •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])
- •experiencing elevated depressive symptoms with the patient health questionnaire (PHQ-9) total score ranging between 5 to 19
- •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),
- •other psychosis,
- •elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score > 2,
- •function limitation precluded the meditation practice,
- •participated meditation program before,
- •any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck,
- •no access to the internet.
研究组 & 干预措施
Mindfulness-based meditation (MBM)
MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
干预措施: MBM (Behavioral)
back-to-back taVNS and MBM
The VNSM includes a single daily session, five days per week, consisting of back-to-back 20-minute taVNS immediately followed by 20-minute MBM (total ≈ 40 minutes).
干预措施: VNSM (Device)
结局指标
主要结局
Change in pain intensity and interference
时间窗: Baseline and 2 weeks and 8 weeks
The pain intensity and interference will be measured by the brief pain inventory (BPI) and the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) adults short form pain interference 8a measurement. There are 15 items in BPI with 4 items in pain intensity (worst, least, average, right now) and 7 items in pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life).
Change in depressive symptoms
时间窗: Baseline and 2 weeks and 8 weeks
The patient health questionnaire (PHQ-9) will be used to measure depressive symptoms. The PHQ-9 is scored on a scale of 0 to 27, with higher scores indicating greater severity of depressive symptoms. A score of 5 to 9 indicates mild depression, 10 to 14 indicates moderate depression, 15 to 19 indicates moderately severe depression, and 20 or above indicates severe depression.
次要结局
- Quantitative sensory testing (QST)(Baseline and 2 weeks and 8 weeks)
- Conditioned pain modulation (CPM)(Baseline and 2 weeks and 8 weeks)
- Change in chronic pain self-efficacy(Baseline and 2 weeks and 8 weeks)
- Changes in co-occurring symptoms(Baseline and 2 weeks and 8 weeks)
- Changes 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