Breathing and Attention Training for Chronic Low Back Pain

June 7, 2024 updated by: University of Florida
The purpose of this research study is to see if breathing and attention training (BAT) treatments improve pain symptoms and well-being in people who have chronic low back pain (cLBP). For this breathing intervention, you will be randomly assigned to either standard or focused BAT. The standard BAT includes instructions on deep breathing and relaxation. The focused BAT is similar to the standard BAT in most ways but includes extra instructions to help you focus and alter your breathing patterns.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of the proposed pilot randomized controlled trial (RCT) is to examine the safety, feasibility, and acceptability of a 5-day breathing and attention training (BAT) in a sample of 30 adults with cLBP. The secondary objective is to explore preliminary clinical efficacy and potential mechanisms of the breathing interventions (focused-BAT and standard-BAT), by examining changes in clinical pain outcomes and potential pain-related psychological, physiological, and behavioral mediating variables. Both interventions will be delivered via an audio recording in order to standardize the interventions across participants and to enhance treatment fidelity. Results from this study will inform the successful design and implementation of a larger RCT and provide preliminary evidence regarding the potential efficacy of this breathing intervention for people with cLBP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic low back pain consistent with recommendations of the NIH task force on cLBP (i.e., participants with cLBP of at least moderate impact that has persisted on more days than not over the past 3 months)
  • Age 18-65

Exclusion Criteria:

  • Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia).
  • Asthma, breathing problems, or a respiratory disorder (e.g., chronic obstructive pulmonary disease).
  • Daily use of opioids. We will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. Other medications being used will be recorded and controlled in statistical analyses as needed.
  • Uncontrolled hypertension (i.e. SBP/DBP of > 150/95), orthostatic hypotension, cardiovascular or peripheral arterial disease. These exclusions are in place primarily for safety reasons, however, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals.
  • Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, vasovagal syncope) or evidence of previous brain injury, including stroke and traumatic brain injury.
  • Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation.
  • Current substance use disorder or history of hospitalization for treatment of substance use disorder.
  • Pregnant
  • Any significant comorbidities that, in the opinion of the investigators, could interfere with the study or lead to deleterious effects for the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Breathing and Attention Training
The standard breathing and attention training (BAT) includes guided instructions on deep breathing and relaxation. Participants will practice standard BAT once a day for 15 minutes for 5 days in a row.
Behavioral: Breathing and Attention Training
A guided audio recording will instruct participants to alter their breathing and pay attention in specific ways.
Experimental: Focused Breathing and Attention Training
The focused BAT is similar to the standard BAT in most ways but includes extra instructions to help focus and alter breathing patterns. Participants will practice focused BAT once a day for 15 minutes for 5 days in a row.
Behavioral: Breathing and Attention Training
A guided audio recording will instruct participants to alter their breathing and pay attention in specific ways.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment Satisfaction Questionnaire
Time Frame: 3-months
Treatment acceptability and participant satisfaction will be measured with several items rated on a 10-point scale where higher scores represent greater treatment acceptability and satisfaction.
3-months
Incidence of Adverse Events
Time Frame: Through study completion, up to 3-months
Number of serious adverse events
Through study completion, up to 3-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity
Time Frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5
Numerical rating scale (1- "No pain", 10- "Worst pain imaginable") of current pain intensity measured before and after each intervention session.
Baseline, Day 1, Day 2, Day 3, Day 4, Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Breathe for Pain
  • OCR39823 (Other Identifier: UF OnCore)
  • IRB202002612 (Other Identifier: UF IRB-01)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD may be shared upon request by other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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