Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients within the Veterans Affairs Community Based Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness (yoga) and without mindfulness (stretching class)
详细描述
The study will approach all new or existing patients within the chiropractic clinic between the ages of 18 and 89 who have low back pain greater than 12 weeks and pain greater than or equal to 3, who have no contraindications to active exercise. Patients will be queried as to interest and those interested will be consented. The investigators will recruit a total of 20 patients. Patients will then be randomized to receive either an 8 week active exercise class with mindfulness (yoga) or an 8 week active exercise class without mindfulness (stretching class). Both groups will have home exercise requirements and will be held accountable through the use of a home practice log. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey GHS), Self Efficacy (2 Question), Fear Avoidance Belief, Castrophizing and Social Engagement. Outcomes will be collected at baseline, and again at the end of the 8 week intervention. Clinician open ended questionnaire will be given to both study clinicians at the end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Will code data entered into database.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Veterans between the ages of 18-89
- •Lower back pain > 12 weeks
- •Have the ability to exercise independently.
排除标准
- •Subjects will be excluded if
- •They are currently enrolled in or maintain a home meditation practice
- •If they are currently involved in a mindfulness or cognitive behavioral therapy group.
- •If they have participated in a structured group yoga class in the last three months.
- •If they have an open workers compensation or no-fault case or have undergone spinal surgery in the past 6 months.
研究组 & 干预措施
Yoga
Stretching with mindfulness
干预措施: Yoga (stretching plus mindfulness) (Other)
Stretching
Stretching exercises without mindfulness
干预措施: Stretching (Other)
结局指标
主要结局
Feasibility
时间窗: 6 months
The main purpose of the study is to assess feasibility of conducting a larger trial. The study team will assess number of Veterans recruited and enrolled in the study. Number of sessions completed.
次要结局
- PROMIS Global Health Scale (GHS):(baseline, immediately post intervention)
- Pain, Engagement and General activity (PEG)(baseline, immediately post intervention)
研究者
Paul Dougherty, DC
Staff Chiropractor
Canandaigua VA Medical Center