Breathing and Attention Training for Chronic Low Back Pain

NCT04740710 | Completed Phase 1

• 3 other identifiers: Breathe for PainOCR39823IRB202002612
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic Pain; Low Back Pain; Breathing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Pain Intensity

  Baseline, Day 1, Day 2, Day 3, Day 4, Day 5

Study Arms (2)

Standard Breathing and Attention Training

ACTIVE COMPARATOR

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

Focused Breathing and Attention Training

EXPERIMENTAL

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

Interventions

Breathing and Attention Training BEHAVIORAL

A guided audio recording will instruct participants to alter their breathing and pay attention in specific ways.

Focused Breathing and Attention Training; Standard Breathing and Attention Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Pratscher SD, Sibille KT, Fillingim RB. Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study. Pilot Feasibility Stud. 2023 Jan 24;9(1):15. doi: 10.1186/s40814-023-01247-9.

  PMID: 36694217 DERIVED

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Respiratory Aspiration

Interventions

Respiration

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: July 18, 2021
• Primary Completion: November 4, 2022
• Study Completion: January 1, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

US (1)