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Breathing and Attention Training for Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Breathing and Attention Training
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic Pain, Low Back Pain, Breathing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Breathing and Attention Training

Focused Breathing and Attention Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment Satisfaction Questionnaire
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.
Incidence of Adverse Events
Number of serious adverse events

Secondary Outcome Measures

Change in Pain Intensity
Numerical rating scale (1- "No pain", 10- "Worst pain imaginable") of current pain intensity measured before and after each intervention session.

Full Information

First Posted
February 2, 2021
Last Updated
February 14, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04740710
Brief Title
Breathing and Attention Training for Chronic Low Back Pain
Official Title
Breathing and Attention Training for Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2021 (Actual)
Primary Completion Date
November 4, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic Pain, Low Back Pain, Breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Breathing and Attention Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Focused Breathing and Attention Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breathing and Attention Training
Intervention Description
A guided audio recording will instruct participants to alter their breathing and pay attention in specific ways.
Primary Outcome Measure Information:
Title
Treatment Satisfaction Questionnaire
Description
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.
Time Frame
3-months
Title
Incidence of Adverse Events
Description
Number of serious adverse events
Time Frame
Through study completion, up to 3-months
Secondary Outcome Measure Information:
Title
Change in Pain Intensity
Description
Numerical rating scale (1- "No pain", 10- "Worst pain imaginable") of current pain intensity measured before and after each intervention session.
Time Frame
Baseline, Day 1, Day 2, Day 3, Day 4, Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD may be shared upon request by other researchers.

Learn more about this trial

Breathing and Attention Training for Chronic Low Back Pain

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