Integrative Breathwork Intervention for Chronic Pain

Completed · Phase 1/Phase 2

Conditions studied: Chronic Low-back Pain

In brief

The proposed research is to develop and refine a multicomponent breathwork intervention, Guided Respiration Mindfulness Therapy, and to iteratively evaluate its feasibility, acceptability, and plausibility for clinically significant effects in people with chronic low back pain. This integrative breathwork intervention involves a 60-minute breathing session where the focus is to maintain a conscious connected breathing pattern (no pause between inhale and exhale), apply mindful acceptance to somatic sensations, and relax any physical tension. Each breathwork session will be delivered 1-on-1 in person by a trained facilitator. The treatment consists of 8 breathwork sessions, once per week for 8 weeks.

Key facts

Study ID

NCT06546956

Run by

University of Florida

People needed

19

Starts

2024-10-24

Expected to finish

2026-01-09

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women 18-70 years of age.
• Chronic primary low back pain that has persisted for at least 3 months and on most days for the past 6 months.
• Average pain intensity of ≥ 4/10 for the past month.
• Fluent in English.
• Access to internet with a valid email address.
• Able to lay down and stay relatively still for one hour.

You may not qualify if…

• Leg pain, or any other chronic pain, that is greater than low back pain.
• Back pain possibly due to specific conditions (e.g., cancer, infection).
• Ongoing legal action or disability claim related to low back pain.
• Neurological symptoms associated with low back pain, including loss of control or incontinence of bowel or bladder.
• Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia).
• Respiratory disorder (e.g., chronic obstructive pulmonary disease) or moderate to severe asthma within the past 12 months.
• Activity limiting heart disease including cardiovascular or peripheral arterial disease.
• Uncontrolled hypertension (i.e. SBP/DBP of > 160/95) or orthostatic hypotension (e.g., issues with fainting).
• Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or evidence of previous brain injury, including stroke and traumatic brain injury.
• Serious acute physical injuries or any surgery within the past 6 months.
• Serious psychiatric disorder (e.g., schizophrenia) or mental health issues requiring hospitalization within the past 12 months or currently on anti-psychotic medications.
• History of hospitalization or treatment of substance use disorder within the past 12 months.
• Currently undergoing curative or palliative chemotherapy or radiation. Pregnant or plan to become pregnant during the study period.
• Glaucoma or detached retina.
• Current participation or participation in the past 2 months of an interventional research study.
• Cognitive impairment or factors that would preclude comprehension of material and/or full participation in the study.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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