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Integrative Breathwork Intervention for Chronic Pain

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University of Florida

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Chronic Low-back Pain

Treatments

Behavioral: Integrative Breathwork Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06546956
IRB202202844
K01AT012066 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Integrative Breathwork Intervention
Experimental group
Description:
The integrative, multicomponent breathwork intervention that will be tested in this study is called Guided Respiration Mindfulness Therapy. Participants will receive a 60 minute breathwork session once a week for 8 weeks.
Treatment:
Behavioral: Integrative Breathwork Intervention

Trial contacts and locations

1

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Central trial contact

Steven Pratscher, PhD

Data sourced from clinicaltrials.gov

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