Status:
COMPLETED
EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Low Back Pain
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
The central objective of research is to examine the feasibility and acceptability of an 8-month single-arm behavioral intervention (i.e., EMPOWER) among overweight/obese middle-aged and older adults w...
Detailed Description
Chronic low back pain (cLBP) is the leading cause of disability worldwide and is one of the top reasons for seeking healthcare. High-impact low back pain is particularly problematic, defined as chroni...
Eligibility Criteria
Inclusion
- 45-80 years of age
- Have a BMI≥25kg/m2
- Endorse pain in the lower back region (i.e., space between the lower posterior margin of the rib cage and the horizontal gluteal fold), knees, or hips
- Pain must occur on at least 50% of the days in the previous six months
- Pain must be rated, at minimum, of moderate intensity (rating of 3 on a numeric rating scale ranging from 0-10)
- Pain impact must be rated as moderate to severe
- Study physician reviews medical record and declares patient medically appropriate for exercise protocol
Exclusion
- Current participation in another psychological treatment or structured weight loss program
- Severe psychiatric illness not adequately controlled by medication or other conditions anticipated to impair intervention engagement (e.g., substance abuse/dependence)
- Presence of chronic, malignant pain (e.g., cancer)
- Significant cognitive impairment (\<26) on the Montreal Cognitive Assessment (MoCA)
- Inability to read and write English
- Currently undergoing radiation or chemotherapy for cancer
- Self-reported cardiac event in the past 6 months or self-reported Heart Failure (CHF)
- Currently pregnant or breastfeeding, or planning to become pregnant during the study time period
- Back, knee, or hip surgery within the past six months of study entry (or planned surgical interventions for pain during forecasted study participation)
- If currently taking prescription analgesic or psychotropic medication, must be stabilized on these treatments for \>4 weeks prior to the baseline assessment
- Blood pressure higher than 180/100 mm Hg at baseline assessment
- Has had bariatric surgery in the past year or is planning to have it in the next year
- If participant reports the presence of systemic inflammatory disease (e.g., rheumatoid arthritis), the study physician will be consulted to determine eligibility
Key Trial Info
Start Date :
November 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04851587
Start Date
November 12 2021
End Date
January 31 2024
Last Update
June 6 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610