Integrative Breathwork Intervention for Chronic Pain

NCT06546956 | Completed Phase 1 DMC

• 2 other identifiers: IRB202202844K01AT012066
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic pain; Breathwork; Mindfulness; Breathing

Outcome Measures

Primary Outcomes (5)

• Treatment Acceptability

  Treatment acceptability and participant satisfaction of the breathwork intervention will be measured using the Client Satisfaction Questionnaire and several face valid items. (0-10; higher values = greater treatment acceptability and satisfaction).

  Post-treatment (after the 8-week intervention)

• Intervention Adherence

  Percentage of intervention sessions attended by participants.

  Post-treatment (Week 8)

• Participant Retention

  Percentage of randomized participants who complete post-treatment assessment.

  Post-treatment (Week 8)

• Change in Pain Intensity

  The Pain, Enjoyment, and General Activities (PEG-3) scale will be used to assess pain intensity over the past week on average. (0-10; higher values = greater pain intensity).

  Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.

• Change in Pain Interference

  The Pain, Enjoyment, and General Activities (PEG-3) will be used assess pain interference over the past week. (0-10; higher values = greater pain interference).

  Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.

Secondary Outcomes (15)

• Treatment Credibility

  After Intervention session 3

• Acute Treatment Effects

  Before and after each intervention sessions (Weeks 1-8)

• Change in Pain Catastrophizing

  Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.

• Change in Pain Self-Efficacy

  Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.

• Change in Fear Avoidance Beliefs

  Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.

Other Outcomes (1)

• Psychological Insight

  Post-treatment (Week 8)

Study Arms (1)

Integrative Breathwork Intervention

EXPERIMENTAL

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.

Behavioral: Integrative Breathwork Intervention

Interventions

Integrative Breathwork Intervention BEHAVIORAL

GRMT has three core components: respiratory regulation (i.e., sustained conscious connected breathing pattern into the upper chest where there is no pause between inhale and exhale), mindfulness of somatic sensations while breathing (i.e., interoceptive awareness with acceptance), and relaxation of physical tension. These components are the primary focus in every breathwork session. The intervention is delivered 1-on-1 in-person with a trained facilitator. Participants lay supine throughout the 60 minute session. The facilitator observes the participant's breathing pattern and guides the participant to apply the three core components. Each session ends with spontaneous, relaxed breathing and an opportunity to briefly share what happened during the session.

Also known as: Guided Respiration Mindfulness Therapy (GRMT)

Integrative Breathwork Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Chronic Pain; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Steven Pratscher, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: October 24, 2024
• Primary Completion: December 10, 2025
• Study Completion: January 9, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)