Clinical trial NCT06977984: Group Integrative Breathwork for Chronic Pain
Official title: Group Breathwork Intervention for Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Breathwork
Chronic Pain
Integrative Breathwork Intervention
Chronic Musculoskeletal Pain
Breathing Therapy
Intervention Development
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will conduct multiple single-arm iterations testing and refining the group breathwork intervention prior to conducting a pilot randomized controlled trial comparing the refined version of the intervention to a waitlist control group.
Primary purpose: TREATMENT

Brief summary: The aim of the proposed research is to iteratively develop, pilot test, and refine an integrative breathwork intervention that is suitable for group delivery to individuals with chronic pain. The intervention will be evaluated for feasibility, acceptability, and plausibility for clinically significant effects in people with chronic musculoskeletal pain.

Detailed description: Multiple single-arm iterations of a group breathwork intervention will be conducted to refine and optimize the intervention and protocol. Upon completion of each iteration, quantitative and qualitative data will be gathered to identify possible modifications before proceeding with the next iteration. After achieving a satisfactory intervention, we will conduct a pilot randomized controlled trial compared to a waitlist control group. This work will provide initial evidence on the feasibility, acceptability, and plausibility of clinically significant effects of this type of multicomponent breathwork intervention for adults with chronic low back pain.

Eligibility criteria: Inclusion Criteria:

1. Men and women 18-70 years of age.
2. Chronic musculoskeletal pain lasting for at least 3 months as a symptom of axial pain (e.g., back, neck) or limb pain (e.g., shoulder, knee, hip, wrist).
3. Average pain intensity of ≥ 4/10 for the past month.
4. Access to internet with a valid email address
5. Able to lay down and stay relatively still for one hour.

Exclusion Criteria:

1. Any suspicion of a medical (orthopedic, rheumatic or neurological) disease, that can fully explain the current level of severity of pain.
2. Chronic pain possibly due to specific conditions (e.g., cancer, infection).
3. Ongoing legal action or disability claim related to chronic pain.
4. Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or moderate or severe symptoms from a previous brain injury, including stroke and traumatic brain injury.
5. Respiratory disorder (e.g., chronic obstructive pulmonary disease) or moderate to severe asthma within the past 12 months.
6. Activity limiting heart disease including cardiovascular or peripheral arterial disease.
7. Uncontrolled hypertension (i.e. SBP/DBP of \> 160/95) or orthostatic hypotension (e.g., issues with fainting).
8. Serious acute physical injuries or major surgery within the past 6 months.
9. Serious psychiatric disorder (e.g., schizophrenia, panic disorder) or mental health issues requiring hospitalization within the past 12 months or currently on antipsychotic medications.
10. History of hospitalization or treatment of substance use disorder within the past 12 months.
11. Currently undergoing curative or palliative chemotherapy or radiation.
12. Pregnant.
13. Glaucoma or detached retina.
14. Current participation or participation in the past 2 months of an interventional research study.
15. Cognitive impairment or factors that would preclude comprehension of material and/or full participation in the study.
16. Any significant comorbidities or other reasons that, in the opinion of the investigators, could interfere with the study or lead to deleterious effects for the participant.

Primary outcomes:
measure: Treatment Acceptability
timeFrame: Day 1
measure: Change in Pain Intensity and Interference
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
Secondary outcomes:
measure: Patient's Global Impressions of Change
timeFrame: 1-week follow-up, 1-month follow-up
measure: Change in Pain Catastrophizing
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
measure: Acute Treatment Effects
timeFrame: Day 1
measure: Change in Pain Self-Efficacy
timeFrame: Change from Baseline to 1-month follow-up
measure: Change in Sleep Disturbances
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
measure: Change in Sleep Related Impairment
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
measure: Change in Fatigue
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
measure: Change in Whole Person Health
timeFrame: Change from Baseline to 1-month follow-up
measure: Change in Stress
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
measure: Change in Anxiety
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
measure: Change in Depression
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
measure: Change in Fear Avoidance Beliefs
timeFrame: Change from Baseline to 1-week follow-up, 1-month follow-up
measure: Change in Interoception
timeFrame: Change from Baseline to 1-month follow-up
measure: Change in Multisensory Sensitivity
timeFrame: Change from Baseline to 1-month follow-up
measure: Psychological Insight
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Clinical Research Center
state: Florida
Study officials:
References: