Breathing and Attention Training for Chronic Low Back Pain

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: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Behavioral: Breathing and Attention Training

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: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	3-months
Incidence of Adverse Events	Number of serious adverse events	Through study completion, up to 3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 1, Day 2, Day 3, Day 4, Day 5

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2021
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Pain; Low Back Pain; Breathing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID 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