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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2028-03-09

Brief Summary

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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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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

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

Study Groups

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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).

Group Type EXPERIMENTAL

Breathing and Attention Training (BAT)

Intervention Type 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.

Controlled Deep Breathing

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

Group Type ACTIVE_COMPARATOR

Breathing Control

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes