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Completed

NCT Number: NCT06455839

Breathwork for 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.

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Key information

Conditions

Pain Chronic Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brian Science and Symptom Management Center

Tallahassee, Florida, 32310, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Resipiration Mindfulness Therapy (GRMT)

Behavioral

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).

Primary outcomes

  1. Number of Participants with Chronic Pain Recruited

    Time frame: 1 week

    Examine recruitment rates during the 1 week of recruitment.

  2. Intervention Adherence

    Time frame: 2 Hours

    Examine the percentage of participants completing their 2-hour intervention session.

  3. Treatment Acceptability

    Time frame: Completed immediately after the 2-hour GRMT training

    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.

Secondary outcomes

  1. Global Impression of Change

    Time frame: Completed at 2- and 6-week follow-ups

    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.

Other outcomes

  1. Acute Pain Unpleasantness

    Time frame: Will be completed immediately before and after the 2-hour intervention session

    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.

  2. Acute Pain Intensity

    Time frame: Will be completed immediately before and after the 2-hour intervention session

    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.

  3. Daily Pain Intensity

    Time frame: Daily for 6 weeks

    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.

  4. Daily Pain Interference

    Time frame: Daily for 6 weeks

    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.

  5. Chronic Pain

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  6. Sleep

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  7. Pain Catastrophizing

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  8. Depression

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  9. Anxiety

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  10. Prescription Pain Medication Use

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  11. Mindful Pain Management

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  12. Self-Transcendent Experiences

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Breathwork Intervention for Individuals With Chronic Musculoskeletal Pain

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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