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

NCT05773482 | Recruiting

• 1 other identifier: IRB202300172
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

Behavioral: Breathing and Attention Training (BAT)

Controlled Deep Breathing

ACTIVE COMPARATOR

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

Behavioral: Breathing Control

Interventions

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 and Attention Training (BAT)

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.

Controlled Deep Breathing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Respiration

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Roland Staud, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melyssa Godfrey

CONTACT

352-265-8901; painresearch@medicine.ufl.edu

Roland Staud, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants who do not receive BAT will be asked to perform deep breathing without mindfulness.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This parallel study will be age \& sex matched, and randomized.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): March 9, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)