Actively Recruiting
Determining Mechanisms of Pain Reduction in Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
Led by New York University · Updated on 2025-01-28
60
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
New York University
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand if surgical weight loss can improve chronic widespread pain in adults with higher body mass index (BMI) who identify as Hispanic/Latino or non-Hispanic Black. The study focuses on changes in pain at rest and movement-evoked pain after bariatric surgery, exploring whether improved pain processing and joint function are linked to pain reduction. Researchers will compare pain and function before and six months after surgery in a single group of participants. Participants will undergo bariatric surgery as part of their standard care for weight loss. The study includes two in-person visits and one remote visit: one visit 1 to 3 months before surgery, a remote visit 3 months after surgery, and a final in-person visit 6 months after surgery. During these visits, researchers will assess pain intensity using the Numeric Pain Rating Scale, evaluate joint motion, and collect health questionnaires and weight measurements. Participants will be involved in pain surveys, weight checks, and health assessments at different time points. The main outcome is the change in pain intensity at rest measured at baseline, 3 months (secondary), and 6 months (primary) after surgery. Movement-evoked pain is also assessed before and 6 months after surgery. Data will be analyzed to understand the relationship between surgical weight loss and pain changes, with safety and health monitored throughout the study period.
CONDITIONS
Brief Title
Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identify as Black/African American or Hispanic/Latino ethnicity based on U.S. Census racial categories
- Eligible candidates for bariatric surgery with BMI �35 with comorbidity or BMI �30
- Have chronic widespread pain with self-reported pain at 3 or more anatomical sites
- Pain present on both sides of the body
- Pain intensity at rest of 3 or higher on Numeric Pain Rating Scale
- Fluent in English or Spanish
- Able to give voluntary written informed consent
- Able to walk independently or with a cane prior to enrollment
You will not qualify if you...
- Previous history of bariatric surgery
- Acute pain lasting less than 6 weeks within 1 month prior to enrollment
- Systemic autoimmune disorder or immunodeficiency
- Unstable psychological condition
- Non-ambulatory or use of assistive device other than a cane
- Pain localized to surgical sites at 3 months post-surgery
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 months before bariatric surgery
Participants undergo laboratory-based measurement and evaluation of pain and weight loss before bariatric surgery.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo bariatric surgery as part of routine care for surgical weight loss.
1 visit (in-person)
Duration - 3 months after surgery
Participants complete pain surveys, weight measurements, and health questionnaires remotely to assess acute post-surgical pain, weight loss, and other health outcomes.
1 off-site (remote) visit
Duration - 6 months after surgery
Participants return for laboratory-based evaluation of pain and weight loss at the primary 6-month endpoint after bariatric surgery.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
NYU Steinhardt Arthur J. Nelson Laboratory
New York, New York, United States, 10010
Actively Recruiting
2
New York City Health + Hospitals/Bellevue Hospital
New York, New York, United States, 10016
Actively Recruiting
3
NYU CTSI Clinical Research Center
New York, New York, United States, 10016
Actively Recruiting
Research Team
E
Ericka N Merriwether, PT, DPT, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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