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Clinical Trials/NCT05773482
NCT05773482RecruitingNot Applicable

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

University of Florida2 sites in 1 country40 target enrollmentStarted: April 3, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
2
Primary Endpoint
Ratings of Painful and Painless Sensory Stimuli

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Participant)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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).

Intervention: 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.

Intervention: Breathing Control (Behavioral)

Outcomes

Primary Outcomes

Ratings of Painful and Painless Sensory Stimuli

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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