Status:
RECRUITING
Integrative Breathwork Intervention for Chronic Pain
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The proposed research is to develop and refine a multicomponent breathwork intervention, Guided Respiration Mindfulness Therapy, and to iteratively evaluate its feasibility, acceptability, and plausib...
Detailed Description
Multiple single-arm iterations of an 8-week breathwork intervention will be conducted to refine and optimize the intervention and protocol. Upon completion of each iteration, quantitative and qualitat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 22 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06546956
Start Date
October 24 2024
End Date
May 22 2027
Last Update
November 6 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610