Feasibility and Acceptability of Interoception-Based Yoga for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported chronic pain lasting ≥ 3 months (such as widespread musculoskeletal pain, fibromyalgia, migraine etc.)
- •In the past week, has pain interfered with your day-to-day activities? Yes
- •Self-reported ambulatory ability without an assistive device
- •Self-reported ability to get on and off the floor without assistance.
- •No ongoing mind-body practice (<1x/week over the past 6 months).
- •Physical Activity Readiness Questionnaire Screen Pass or Physician Consent
- •English-speaking
- •Able and willing to provide consent
- •No plans to move or travel outside the area in the next 2 months
排除标准
- •Ages <18 or ≥ 65 at time of screening
- •Pain lasting < 3 months
- •In the past week, has pain interfered with your day-to-day activities? No
- •Use of any assistive device (e.g. cane, walker, wheelchair).
- •Inability to get on and off the floor without assistance.
- •A consistent ongoing mind-body practice (mindfulness, yoga, meditation, tai chi, qigong), at least 1x/week over the past 6 months
- •Physical Activity Readiness Questionnaire Screen Fail or non-consent of physician
- •Non-English speaking
- •Non-consent
- •Plans to move or significant travel outside the area in the next 2 months
- •Known pregnancy
- •Recent surgery or acute bone, joint or nerve injury (within the past 6 months)
- •Severe or progressive neurological conditions such as Parkinson's disease, dementia, multiple sclerosis, or acquired brain injury
- •Separate pain-related diagnoses: cancer-related pain, complex regional pain syndrome, postural orthostatic tachycardia syndrome, functional neurological/ movement disorders
- •Active or planned worker's compensation or personal injury claim
- •Concurrent participation in another interventional study (e.g. physical activity, mind-body or drug trials)
研究组 & 干预措施
Yoga Intervention
Interoception-based yoga intervention, 2x/week for 6 weeks.
干预措施: Yoga Intervention (Behavioral)
结局指标
主要结局
Feasibility
时间窗: Primary endpoint: 6 weeks
Defined as achieving the target recruitment sample (N=25) in a 9-month period, 80% retention (N=20), 70% attendance rate, 70% home practice adherence and no serious adverse events.
Acceptability
时间窗: Primary endpoint: 6 weeks
Defined as \>5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable)
次要结局
- Interoceptive Sensibility(Primary endpoint: 6 weeks)
- PROMIS Pain Interference(Primary endpoint: 6 weeks)