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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773482
• Other study ID #: IRB202300172
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: March 9, 2028

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Melyssa Godfrey
• Phone: 352-265-8901
• Email: painresearch[@]medicine.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 9, 2028
• Est. primary completion date: March 9, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia

Intervention

Behavioral:
• Breathing and Attention Training (BAT)
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
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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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