Status:
COMPLETED
Breathing and Attention Training for Chronic Low Back Pain
Lead Sponsor:
University of Florida
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 breathi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04740710
Start Date
July 18 2021
End Date
January 1 2023
Last Update
June 10 2024
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610