Integrative Breathwork Intervention for Chronic Pain

Last updated: October 29, 2024
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

1/2

Condition

Pain

Chronic Pain

Treatment

Integrative Breathwork Intervention

Clinical Study ID

NCT06546956
IRB202202844
K01AT012066
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 mostdays 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

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 orincontinence of bowel or bladder.

  • Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupuserythematosus, fibromyalgia).

  • Respiratory disorder (e.g., chronic obstructive pulmonary disease) or moderate tosevere asthma within the past 12 months.

  • Activity limiting heart disease including cardiovascular or peripheral arterialdisease.

  • 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 ofseizures) or evidence of previous brain injury, including stroke and traumatic braininjury.

  • Serious acute physical injuries or any surgery within the past 6 months.

  • Serious psychiatric disorder (e.g., schizophrenia) or mental health issues requiringhospitalization within the past 12 months or currently on anti-psychoticmedications.

  • History of hospitalization or treatment of substance use disorder within the past 12months.

  • Currently undergoing curative or palliative chemotherapy or radiation. Pregnant orplan to become pregnant during the study period.

  • Glaucoma or detached retina.

  • Current participation or participation in the past 2 months of an interventionalresearch study.

  • Cognitive impairment or factors that would preclude comprehension of material and/orfull participation in the study.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Integrative Breathwork Intervention
Phase: 1/2
Study Start date:
October 24, 2024
Estimated Completion Date:
May 22, 2027

Study 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.

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.