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临床试验/NCT05773482
NCT05773482招募中不适用

Effects of Breathing and Attention Training (BAT) on Pain Modulation in Healthy Individuals and Patients With Chronic Musculoskeletal Pain

University of Florida2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Ratings of Painful and Painless Sensory Stimuli

研究概览

简要总结

The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants who do not receive BAT will be asked to perform deep breathing without mindfulness.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals diagnosed with fibromyalgia will have pain of duration > 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR)
  • Healthy, pain-free age matched controls without chronic pain

排除标准

  • Personal or family history of photosensitive epilepsy
  • Prior history of cancer or diabetes
  • Patients must be willing to discontinue their analgesics, hypnotics, anxiolytics, or anti-depressants during the study period for at least 5 half-lives.

研究组 & 干预措施

Breathing and Attention Training (BAT)

Experimental

Participants will be asked to do 20-minutes of focused breathing and attention training, involving focusing on taking deep breaths and becoming aware of the changing body sensations associated with breathing (mindfulness).

干预措施: Breathing and Attention Training (BAT) (Behavioral)

Controlled Deep Breathing

Active Comparator

Participants will be asked to do 20-minutes of deep breathing and letting the body relax.

干预措施: Breathing Control (Behavioral)

结局指标

主要结局

Ratings of Painful and Painless Sensory Stimuli

时间窗: 2 hr

Ratings of painful and non-painful stimuli in FM subjects and HC will be obtained before and after BAT or Deep Breathing. Painful stimuli will include pressure stimuli. Painless stimuli will consist of flashing light stimuli.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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