Breathwork intervention for chronic low-back pain
Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain
This study is testing a new breathing therapy to see if it can help people with chronic low back pain feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06546956 on ClinicalTrials.gov |
What this trial studies
This research aims to develop and refine a breathwork intervention called Guided Respiration Mindfulness Therapy for individuals suffering from chronic low back pain. The intervention consists of 8 weekly, one-on-one sessions with a trained facilitator, focusing on conscious connected breathing and mindful acceptance of bodily sensations. The study will iteratively evaluate the feasibility, acceptability, and potential clinical effects of this approach through both quantitative and qualitative data collection after each iteration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with chronic primary low back pain lasting at least 3 months and an average pain intensity of 4/10 or higher.
Not a fit: Patients with significant leg pain, specific underlying conditions causing back pain, or respiratory disorders may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could provide a non-pharmacological option for managing chronic low back pain.
How similar studies have performed: While breathwork interventions are gaining interest, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Steven Pratscher, PhD — University of Florida
- Study coordinator: Steven Pratscher, PhD
- Email: Spratscher@ufl.edu
- Phone: 352-273-9510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.