Group Integrative Breathwork for Chronic Pain

University of Florida

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: Integrative Breathwork Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06977984

IRB202500383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Integrative Breathwork Intervention

Experimental group

Description:

The breathwork intervention will be delivered in groups of 2-5 participants with chronic musculoskeletal pain. A conscious connected breathing technique will be engaged in for 45-60 minutes.

Treatment:

Behavioral: Integrative Breathwork Intervention