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

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT05773482

Collaborator

(none)

Enrollment

Location

Arms

59.3

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Behavioral: Breathing and Attention Training (BAT) Behavioral: Breathing Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This parallel study will be age & sex matched, and randomized.This parallel study will be age & sex matched, and randomized.

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Mar 9, 2027

Anticipated Study Completion Date :

Mar 9, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	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.
Active Comparator: Controlled Deep Breathing Participants will be asked to do 20-minutes of deep breathing and letting the body relax.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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).

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.

Active Comparator: Controlled Deep Breathing

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Roland Staud, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT05773482

Other Study ID Numbers:

IRB202300172

First Posted:

Mar 17, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibromyalgia

Study Results

No Results Posted as of Mar 24, 2023