Clinical trial NCT06546956: Integrative Breathwork Intervention for Chronic Pain
Official title: Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Low-back Pain
Keywords: Chronic pain
Breathwork
Mindfulness
Breathing
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-08-09
Enrollment: 30
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
Primary purpose: TREATMENT

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 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.

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 qualitative data will be gathered to identify possible modifications before proceeding with the next iteration. 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:

* 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.

Primary outcomes:
measure: Treatment Acceptability
timeFrame: Post-treatment (after the 8-week intervention)
measure: Intervention Adherence
timeFrame: Post-treatment (Week 8)
measure: Participant Retention
timeFrame: Post-treatment (Week 8)
measure: Change in Pain Intensity
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Pain Interference
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Secondary outcomes:
measure: Treatment Credibility
timeFrame: After Intervention session 3
measure: Acute Treatment Effects
timeFrame: Before and after each intervention sessions (Weeks 1-8)
measure: Change in Pain Catastrophizing
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Pain Self-Efficacy
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Fear Avoidance Beliefs
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Physical Function
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Sleep Disturbance
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Sleep Related Impairment
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Fatigue
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Stress
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Anxiety
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Depression
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Multisensory Sensitivity
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Interoception
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
measure: Change in Mindful Reappraisal of Pain Sensations
timeFrame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Other outcomes:
measure: Psychological Insight
timeFrame: Post-treatment (Week 8)
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Steven Pratscher, PhD
role: PRINCIPAL_INVESTIGATOR
References: