Breathwork for Chronic Musculoskeletal Pain

Breathwork Intervention for Individuals With Chronic Musculoskeletal Pain

This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (CCBR) training for chronic musculoskeletal pain.

Study Overview

• Status: Completed
• Conditions: Pain; Musculoskeletal Pain; Chronic Pain; Pain, Chronic
• Intervention / Treatment: Behavioral: Guided Resipiration Mindfulness Therapy (GRMT)

Detailed Description

CCBR is a breathwork style that involves breathing with no pause between inhalation and exhalation (also known as circular breathing). This breathing pattern is maintained for a given period of time, ranging from 5 minutes to over 2 hours. In the proposed project, the CCBR training will begin with a 15-minute introduction to CCBR, followed by an hour and 15 minutes of therapist-guided CCBR practice. The final 30 minutes will be used to discuss participant experiences during the CCBR practice. CCBR training sessions will occur in-person and in a small group format (5 participants each).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32310
      • Brian Science and Symptom Management Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• having received a professional diagnosis of clinical levels of chronic pain
• being able to not commit to another (new) treatment during the course of the study
• understanding English instructions fluently
• Being 18 and above

Exclusion Criteria:

• having learned to practice breathwork any time in the past
• being unable to perform most basic tasks due to pain or pain treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Guided Respiration Mindfulness Therapy

Behavioral: Guided Resipiration Mindfulness Therapy (GRMT); GRMT provides training in respiratory regulation, mindfulness and relaxation. The GRMT training will begin with a 15-minute introduction to the treatment model, followed by an hour of therapist-guided respiration (i.e., continuous rhythmic expansion of the chest, and relaxed exhalation involving release of all respiratory and peripheral musculature). The final 45 minutes will be used to discuss participant experiences during the GRMT training. GRMT training sessions will occur in-person and in a small group format (<5 participants each).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Adherence	Examine the percentage of participants completing their 2-hour intervention session.	2 Hours
Number of Participants with Chronic Pain Recruited	Examine recruitment rates during the 1 week of recruitment.	1 week
Treatment Acceptability	Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Scores range from 5 to 45. Higher scores reflect greater acceptability.	Completed immediately after the 2-hour GRMT training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Impression of Change	Treatment related improvement will be assessed with the Patient Global Impression of Change scale. Scores range from 0 to 7, with higher scores reflecting greater treatment related improvement.	Completed at 2- and 6-week follow-ups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Pain Intensity	Change in daily pain intensity from from the first post-intervention day through the 6-week follow-up will be assessed with the pain intensity item from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity.	Daily for 6 weeks
Daily Pain Interference	Change in daily pain interference from from the first post-intervention day through the 6-week follow-up will be assessed with the two pain interference items from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain interference.	Daily for 6 weeks
Chronic Pain	Change in chronic pain from baseline through 6-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater chronic pain.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Sleep	Change in sleep from baseline through 6-week follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Pain Catastrophizing	Change in pain catastrophizing from baseline through 6-week follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Depression	Change in depression from baseline through 6-week follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Anxiety	Change in anxiety from baseline through 6-week follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Prescription Pain Medication Use	Change in prescription pain medication misuse from baseline through 6-week follow-up will be assessed with the PROMIS Prescription Pain Medication Misuse Short Form. Scores range from 7 to 35, with higher scores reflecting greater medication misuse.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Mindful Pain Management	Change in the use of mindfulness for pain management from baseline through 6-week follow-up will be assessed with the Mindful Reappraisal of Pain Scale. Scores range from 0 to 54, with higher scores reflecting greater mindful pain management.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Acute Pain Unpleasantness	Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.	Will be completed immediately before and after the 2-hour intervention session
Acute Pain Intensity	Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.	Will be completed immediately before and after the 2-hour intervention session
Self-Transcendent Experiences	Change in the the frequency of self-transcendent experiences from baseline through 6-week follow-up will be assessed with the Nondual Awareness Dimensional Assessment. Scores range from 0 to 5, with higher scores reflecting more frequent self-transcendent experiences.	Baseline, 2 weeks post-treatment, 6 week post-treatment

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2024
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): July 27, 2024

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain; Chronic Pain
• Other Study ID Numbers: 00005048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No