Combined Meditation and Exercise as a Treatment for Patients With Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Roland Morris Disability Questionnaire
研究概览
简要总结
This study evaluates the analgesic effect of a combination treatment of exercise and mindfulness based meditation in patients with chronic back pain. Half of the participants will partake in a 4-week exercise and meditation intervention, while the other half will receive a placebo treatment. The investigators hypothesize that a combination treatment reduces disability and pain more than the control intervention.
详细描述
Exercise and mindfulness based mediation can both produce analgesic effects in patients with chronic pain, but the mechanisms are not clear.
Combining treatments could produce analgesic effects that are additive, synergistic, or counteractive to each other. Here, the investigators examine the effects of a 4-week intervention in patients with chronic low back pain. Patients are assigned to a meditation/exercise group or a control group. The investigators will measure pain and disability using a variety of tools including surveys (disability, anxiety, mindfulness, and pain), pain VAS scales, and quantitative sensory testing.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of clinically diagnosed nonspecific low back pain for at least 6 months
- •Body mass index within the normal to overweight range (18.5-29.9)
- •Resting heart rate 60 to 100 beats per minute
- •Resting blood pressure less than or equal to 140/90
- •Able to independently ambulate community distances without external support (e.g., walker, cane)
排除标准
- •Age less than 18 or greater than 60 years
- •BMI ≥ 30 or ≤ 18.4
- •Cardiovascular or respiratory disease
- •Neurological disease, unrelated to low back pain
- •Radicular low back pain
- •Back pain associated with neuropathy
- •Diabetes mellitus, Types 1 and 2
- •Diagnosed with a chronic pain condition, unrelated to low back pain
- •Regular participation in high intensity athletic/sporting activities
- •Sedentary lifestyle
- •Currently pregnant
- •Current cigarette smoker
- •On-going litigation associated with back pain
- •Inability to walk independently without external support (e.g. walker).
- •Regular participation in meditation techniques or training in Mindfulness-based stress reduction
研究组 & 干预措施
Exercise and Meditation
The Exercise and Meditation group will practice mindfulness meditation immediately before walking treadmill exercise, five days per week for four weeks.
干预措施: Exercise and Meditation (Behavioral)
Control
The Control group will listen to an audio book followed by quiet rest, five days per week for four weeks.
干预措施: Control (Behavioral)
结局指标
主要结局
Change in Roland Morris Disability Questionnaire
时间窗: baseline and 4 weeks
The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability).
次要结局
- Change in Cutaneous Sensation(baseline and 4 weeks)
- Fear Avoidance Beliefs Questionnaire(baseline and 4 weeks)
- Freiburg Mindfulness Inventory(baseline and 4 weeks)
- VAS back pain (intensity & unpleasantness)(baseline, daily (pre and post intervention), and 4 weeks)
- State-Trait Anxiety Inventory (STAI)(baseline and 4 weeks)
- Change in Pressure Sensation(baseline and 4 weeks)
- Change in Heat unpleasantness(baseline and 4 weeks)
研究者
Matthew Kostek
Assistant Professor
Duquesne University