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

NCT05773482 — Not applicable, Recruiting, 40 participants, University of Florida

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

Registry	NCT05773482
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, basic science
Enrollment	40 (Estimated)
Sponsor	University of Florida (Other)
Conditions	Fibromyalgia
Interventions	Breathing and Attention Training (BAT), Breathing Control (Behavioral)
Dates	start 2023-04-03, primary completion 2027-03-09 (estimated), completion 2028-03-09 (estimated), first posted 2023-03-17, last updated 2026-07-06
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Breathing and Attention Training (BAT)	Experimental	Behavioral: Breathing and Attention Training (BAT)	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).
Controlled Deep Breathing	Active comparator	Behavioral: Breathing Control	Participants will be asked to do 20-minutes of deep breathing and letting the body relax.

Breathing and Attention Training (BAT) (Behavioral): 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.
Breathing Control (Behavioral): 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.

+Outcome measures

Primary outcomes

Ratings of Painful and Painless Sensory Stimuli [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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
University of Florida	Gainesville, Florida	United States	Recruiting

+Investigators

Roland Staud, MD, Principal investigator, University of Florida