Breathwork for Chronic Musculoskeletal Pain

Pain Clinical Trial

Official title:

Breathwork Intervention for Individuals With Chronic Musculoskeletal Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455839
• Other study ID #: 00005048
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: June 2024
• Source: Florida State University
• Contact: Adam Hanley, PhD
• Phone: 850-508-0286
• Email: adam.hanley[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour Guided Respiration Mindfulness Therapy training for chronic musculoskeletal pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• having received a professional diagnosis of clinical levels of chronic pain
• being able not to 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.

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain
• Pain
• Pain, Chronic

Intervention

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).

Locations

Country	Name	City	State
United States	Brian Science and Symptom Management Center	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Recruitment Feasibility	Examine recruitment rates during the 1 week of recruitment.	1 week
Primary	Intervention Adherence	Examine the percentage of participants completing their 2-hour intervention session.	2 Hours
Primary	Treatment Acceptability	Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Higher scores reflect greater acceptability.	Completed immediately after the 2-hour GRMT training
Secondary	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