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Behavioral Intervention

Guided Respiration Mindfulness Therapy for Chronic Lower Back Pain

Phase 1 & 2

Recruiting

Led By Steven Pratscher, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic primary low back pain that has persisted for at least 3 months and on most days for the past 6 months

Men and women 18-70 years of age

Must not have

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

Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or evidence of previous brain injury, including stroke and traumatic brain injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (week 0) to post-treatment (week 8), 1-month follow-up.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to develop and test a new breathing technique called Guided Respiration Mindfulness Therapy for people with chronic low back pain. The therapy involves 60-minute breathing sessions where participants focus on breathing

Who is the study for?

This trial is for individuals experiencing chronic lower back pain. Participants should be interested in exploring alternative therapies and available to attend eight weekly sessions of breathwork therapy with a trained facilitator.

What is being tested?

The study tests Guided Respiration Mindfulness Therapy, an integrative breathwork intervention designed to help with chronic low back pain. It involves 60-minute one-on-one sessions focusing on continuous breathing patterns and mindful relaxation over eight weeks.

What are the potential side effects?

As this is a non-invasive therapy focused on breathing techniques, significant side effects are not anticipated. However, participants may experience temporary discomfort or emotional responses during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had lower back pain almost daily for the past 6 months.

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I am between 18 and 70 years old.

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My average pain level has been 4 or higher in the past month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had asthma or a lung condition like COPD in the last year.

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I have a neurological condition like Parkinson's or a history of brain injury.

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My leg pain is worse than my lower back pain.

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I experience loss of control over bowel or bladder due to my back pain.

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I have heart disease that limits my physical activity.

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I do not have high blood pressure above 160/95 or problems with fainting.

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I have not had any serious injuries or surgeries in the last 6 months.

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I am currently receiving chemotherapy or radiation aimed at curing or managing my cancer.

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I have glaucoma or a detached retina.

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I have a condition like rheumatoid arthritis or lupus.

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I have not been hospitalized for mental health issues nor am I on anti-psychotic medication.

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I understand and can fully participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (week 0) to post-treatment (week 8), 1-month follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (week 0) to post-treatment (week 8), 1-month follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (week 0) to post-treatment (week 8), 1-month follow-up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Intensity

Change in Pain Interference

Intervention Adherence

+2 more

Secondary study objectives

Acute Treatment Effects

Change in Anxiety

Change in Depression

+12 more

Other study objectives

Psychological Insight

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Integrative Breathwork InterventionExperimental Treatment1 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.

0 / 15Eligibility criteria met