Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Multi-Dimensional Treatment Satisfaction Measure
研究概览
简要总结
This feasibility study will evaluate yoga as a treatment for chronic musculoskeletal pain. The experimental treatment is yoga delivered via a tablet computer to participants at home ("teleyoga"). First, the investigators will develop a suitable protocol for teleyoga. Second, the investigators will demonstrate the feasibility of conducting a randomized controlled trial involving randomization to teleyoga or in-person yoga groups.
详细描述
The first phase of the study is not randomized. In this phase, the first group of participants (n=10) will all participate in a tele-yoga class using an iPad loaned to them by the study. They will attend this treatment session from the comfort of their home or a location of their choice. Yoga treatment will last 12 weeks. At the end of treatment, veterans will provide feedback by completing a satisfaction questionnaire to rate various aspects of the teleyoga (e.g. technical challenges, ability to perform yoga through the video-conferencing platform, problems that occurred, and recommendations to improve the class, etc). The teleyoga protocol will be modified on the basis of this feedback and will be tested on a second group of participants (n=10). The second phase of the study will involve randomization of a further group of participants (n=30) to either the teleyoga developed in phase one, or in-person yoga.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
End-of-treatment assessments will be conducted by an assessor who is blind to treatment modality.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical clearance for participation by VA primary care provider
- •Diagnosis of musculoskeletal pain > 6 months
- •Minimum pain intensity of 4 at screening on 0-10 scale
- •Any psychotropic treatments stable for at least 4 weeks before study
- •English literacy
- •Wireless Internet connection at home
排除标准
- •Current participation in another clinical trial
- •Back surgery within the last 12 months
- •Back pain related to a specific underlying cause, disease, or condition
- •Baseline pain <4 or >9 on 0-10 scale
- •Unstable, serious coexisting medical illness
- •Unstable, serious coexisting mental illness
- •Attended or practiced yoga ≥1 time in the past 12 months
- •Active current suicidal plan or intent
结局指标
主要结局
Multi-Dimensional Treatment Satisfaction Measure
时间窗: after 12 weeks of treatment
A participant satisfaction measure \[score range: 0 to 4\]. The higher the value, the greater the treatment satisfaction
Adherence to the Treatment Protocol
时间窗: during 12 weeks of treatment
% of randomized patients who attend ≥65% of treatment sessions
Attrition
时间窗: during 12 weeks of treatment
number of randomized patients who drop out of treatment
次要结局
未报告次要终点
研究者
Peter Bayley
Principal Investigator
Palo Alto Veterans Institute for Research