Clinical trial NCT04740710: Breathing and Attention Training for Chronic Low Back Pain
Official title: Breathing and Attention Training for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Low-back Pain
Keywords: Chronic Pain
Low Back Pain
Breathing
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment Satisfaction Questionnaire
timeFrame: 3-months
measure: Incidence of Adverse Events
timeFrame: Through study completion, up to 3-months
Secondary outcomes:
measure: Change in Pain Intensity
timeFrame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: