Testing the Efficacy of Enhanced Biofeedback on Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Changes in clinical pain
研究概览
简要总结
The purpose of this study is to assess whether a novel, enhanced form of biofeedback can help individuals regulate their chronic musculoskeletal pain more effectively.
详细描述
Relaxation is a low-cost treatment for managing pain with little or no side effects. The proposed study will use a novel biofeedback treatment to try and enhance the capacity of relaxation to engage pain inhibitory circuits. Specifically, a biofeedback system (Biofeedback Training for Conditioned Pain Regulation, BT-CPR) will be used to monitor the participant's level of sympathetic arousal and will use this to control the intensity of painful stimulations delivered to the participant during biofeedback training. Thus, when the participant successfully relaxes (and reduces their arousal), the intensity is lowered and produces pain relief. Efficacy of the treatment will be tested in a small, randomized controlled trial in which individuals with a verified diagnosis of chronic musculoskeletal pain will receive 10 treatment sessions, or 10 sessions of a control condition (traditional biofeedback, to control for the effects of relaxation on pain). The aim will be to assess whether the treatment results in improvements in clinical pain outcomes (e.g., pain intensity, quality of life, pain interference) and psychosocial variables (e.g., coping, self-efficacy, mood).
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
- None
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
- •Adults (18 years or older) with a verified diagnosis of chronic musculoskeletal pain and currently experiencing pain
排除标准
- •under 18 years of age (given the nature of the treatment study)
- •if female, currently pregnant
- •persistent feelings of numbness in hands and feet
- •difficulty being able to feel or sense things
- •lack of access to a computer or smartphone (to complete electronic pain diaries)
- •injuries that prevent sensor application
- •use of narcotic pain medications with 48 hours of treatment sessions
研究组 & 干预措施
BT-CPR
Participants will receive training in relaxation and biofeedback to develop skills in relaxation/arousal reduction, and pain reduction. Then they will practice relaxing and reducing their arousal as they view graphical arousal feedback. Electric stimulations will be delivered throughout the biofeedback training to provide pain relief when relaxation is achieved.
干预措施: Biofeedback Training (BT-CPR) (Behavioral)
Biofeedback-Only
Participants will receive training in relaxation and biofeedback to develop skills in relaxation/arousal reduction, and pain reduction. Then they will practice relaxing and reducing their arousal as they view graphical arousal feedback.
干预措施: Biofeedback Training (Behavioral)
结局指标
主要结局
Changes in clinical pain
时间窗: Assessed daily via electronic diaries starting 1 week prior to session 1 and ending 1 week after session 10 (up to 11 weeks)
Self-report ratings of pain intensity, rated using 0-10 Likert-type scales, (i.e., 0 = no pain; 10 = most intense pain).
Changes in psychosocial outcomes
时间窗: Assessed daily via electronic diaries starting 1 week prior to session 1 and ending 1 week after session 10 (up to 11 weeks)
Self-report ratings of pain interference, mood, sleep quality, and coping. These items are rated using 0-10 Likert-type scales, (e.g., 0 = no change; 10 = extreme change) with higher values indicating an increase in the variable assessed on a particular item (e.g., interference with daily activities).
次要结局
- Changes in reactions to painful stimuli(Assessed immediately before the first treatment session (Time 1) and immediately after (Time 2) the last treatment session (approximately 10 weeks from Time 1).)
研究者
Jamie Rhudy
Professor
University of Tulsa