Integrative Breathwork Intervention for Chronic Pain

NCT ID: NCT06546956

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2027-05-22

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic pain; Breathwork; Mindfulness; Breathing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Integrative Breathwork Intervention

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.

Group Type: EXPERIMENTAL

Integrative Breathwork Intervention

Intervention Type: 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.

Interventions

Integrative Breathwork Intervention

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Guided Respiration Mindfulness Therapy (GRMT)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Pratscher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Pratscher, PhD

Role: CONTACT

Phone: 352-273-9510

Email: Spratscher@ufl.edu

Facility Contacts

Steven Pratscher, PhD

Role: primary

Other Identifiers

K01AT012066

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202202844

Identifier Type: -

Identifier Source: org_study_id