Chronic Low-back PainPhase 1/2NCT06546956
Integrative Breathwork Intervention for Chronic Pain
A Phase 1/2 study testing Integrative Breathwork Intervention in people with Chronic Low-back Pain, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Integrative Breathwork Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2024to 9 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain
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.
Read the 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
- Being tested
- Integrative Breathwork Intervention
- Keywords
- Chronic pain, Breathwork, Mindfulness, Breathing
- Medical subject headings
- Chronic Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Breathwork InterventionBehavioural
Also called Guided Respiration Mindfulness Therapy (GRMT)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrative Breathwork Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-treatment (after the 8-week intervention)
Intervention Adherence
Percentage of intervention sessions attended by participants.
Measured: Post-treatment (Week 8)
Participant Retention
Percentage of randomized participants who complete post-treatment assessment.
Measured: 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).
Measured: 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).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Secondary outcomes (15)
Treatment Credibility
Assessed using the 8-item Credibility and Expectancy Questionnaire where higher scores represent higher levels of treatment credibility. (1-9; higher values = greater treatment expectancy and credibility).
Measured: After Intervention session 3
Acute Treatment Effects
Assessed using face-valid items related to feelings and emotions immediately before and after each intervention session. Change scores will be calculated from post-intervention to pre-intervention. (0-4; higher scores = greater changes in acute subjective effects).
Measured: Before and after each intervention sessions (Weeks 1-8)
Change in Pain Catastrophizing
Assessed using the 13-item Pain Catastrophizing Scale. (Scores range from 0-52; higher scores represent higher levels of pain catastrophizing).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Pain Self-Efficacy
Assessed using the 10-item Pain Self-Efficacy Scale. (0-6; higher scores represent higher levels of pain self-efficacy).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Fear Avoidance Beliefs
Assessed using the 5-item Fear-Avoidance Beliefs Questionnaire-physical activity subscale. (0-6; higher scores represent higher levels of physical activity-related fear-avoidance beliefs).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Physical Function
The PROMIS Physical Function-6b will be used assess pain dysfunction. (1-5; higher scores represent higher levels of physical function).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Sleep Disturbance
Assessed using the PROMIS-Sleep Disturbance 8b scale. (1-5; higher scores represent higher levels of sleep disturbance).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Sleep Related Impairment
Assessed using the PROMIS-Sleep Related Impairment 8a scale. (1-5; higher scores represent higher levels of sleep related impairment).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Fatigue
Assessed using the PROMIS Fatigue-8a scale. (1-5; higher scores represent higher levels of fatigue over the past week).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Stress
Assessed using the 4-item Perceived Stress Scale. (0-4; higher scores represent higher levels of subjective stress over the past month).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Anxiety
Assessed using the Generalized Anxiety Disorder-2 Questionnaire. (0-3; higher scores represent higher levels of anxiety over the past 2 weeks).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Depression
Assessed using the Patient Health Questionnaire-2.(0-3; higher scores represent higher levels of depression over the past 2 weeks).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Multisensory Sensitivity
Assessed using the Multisensory Amplification Scale will be used to assess symptoms of central nervous system hypersensitivity, or central sensitization. (1-5; higher scores represent higher levels of sensory sensitivity).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Interoception
Assessed using the Multidimensional Assessment of Interoceptive Awareness-2. (0-5; higher scores represent higher levels of interoception).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Mindful Reappraisal of Pain Sensations
Assessed using the Mindful Reappraisal of Pain Sensations Scale. (0-6; higher scores represent higher levels of mindful reappraisal).
Measured: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start24 Oct 2024
- Primary completion10 Dec 2025
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Steven Pratscher, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546956
- Sponsor's protocol ID
- IRB202202844
- Other IDs
- K01AT012066
- Status last verified
- Apr 2026
- First submitted
- 30 Jul 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain
- ClinicalTrials.gov ID
- NCT06546956
- Acronym / sponsor ID
- IRB202202844
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic pain, Breathwork, Mindfulness, Breathing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative Breathwork Intervention | Experimental | Behavioral: Integrative Breathwork InterventionThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Breathwork InterventionAlso: Guided Respiration Mindfulness Therapy (GRMT)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. | Behavioural | Integrative Breathwork Intervention |
Primary outcome
Treatment Acceptability
Time frame: Post-treatment (after the 8-week intervention)
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).
Intervention Adherence
Time frame: Post-treatment (Week 8)
Percentage of intervention sessions attended by participants.
Participant Retention
Time frame: Post-treatment (Week 8)
Percentage of randomized participants who complete post-treatment assessment.
Change in Pain Intensity
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
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 in Pain Interference
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
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).
15 secondary outcomes
Treatment Credibility
Time frame: After Intervention session 3
Acute Treatment Effects
Time frame: Before and after each intervention sessions (Weeks 1-8)
Change in Pain Catastrophizing
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Pain Self-Efficacy
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Fear Avoidance Beliefs
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Physical Function
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Sleep Disturbance
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Sleep Related Impairment
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Fatigue
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Stress
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Anxiety
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Depression
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Multisensory Sensitivity
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Interoception
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Change in Mindful Reappraisal of Pain Sensations
Time frame: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Pratscher, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Integrative Breathwork Intervention in people with Chronic Low-back Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Acceptability (time frame: Post-treatment (after the 8-week intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.