Effects of Breathing and Attention Training (BAT) on Pain Modulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Breathing and Attention Training (BAT)
* Behavioral: Breathing Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This parallel study will be age & sex matched, and randomized.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing and Attention Training (BAT)<br>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). | Behavioral: Breathing and Attention Training (BAT)<br>* BAT is an instructor guided breathing technique over 20 min that will be applied once in a training session and approximately one week later in a testing session.<br>|
| Active Comparator: Controlled Deep Breathing<br>Participants will be asked to do 20-minutes of deep breathing and letting the body relax. | Behavioral: Breathing Control<br>* Controlled Breathing (without mindfulness) is an instructor guided breathing technique over 20 min that will be applied once in a training session and approximately one week later in a testing session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratings of Painful and Painless Sensory Stimuli | 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. | 2 hr |