NCT06795386

Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults

Determining Mechanisms of Pain Reduction in Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: New York University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn if surgical weight loss can improve chronic widespread pain in people living with higher BMI who self-identify as Hispanic/Latino ethnicity or non-Hispanic Black based on the United States census racial categories. The main questions the study aims to answer are: 1. Do pain at rest (primary outcome) and movement-evoked pain (secondary outcome) improve after bariatric surgery? 2. Do pain processing and joint function change after bariatric surgery? 3. Are pain processing and joint function associated with clinically significant pain change after surgical weight loss? Researchers will compare pain and function before and 6 months after bariatric surgery in a single cohort.

Detailed description

The central hypothesis that will be tested is that pain at rest (primary outcome) and movement-evoked pain (MEP, secondary outcome) will decrease after bariatric surgery. We will also determine if pain reduction will be mediated by improved pain modulation and select joint motion and loading variables. The study will feature a prospective, observational quasi-experimental cohort study design for within-group analyses of pain at rest and MEP using the Numeric Pain Rating Scale (NPRS) and other exploratory outcomes before and 6 months after bariatric surgery. Pain at rest and MEP at 3 months after bariatric surgery are secondary endpoints. All participants will attend two in-person study visits and one off-site (remote) visit. Laboratory-based measurement and evaluation of pain and weight loss will be conducted during two in-person visits 1-3 months before bariatric surgery (Visit 1) at 6 months (Visit 3, primary endpoint). Pain surveys, weight measurements, and health questionnaires will be administered online or via telephone 3 months after surgery to assess acute post-surgical pain, weight loss, and other secondary and exploratory health outcomes (Visit 2). Descriptive analyses of all data will be performed by the NYU Biostatistics Resource directed by Dr. Huilin Li.

Conditions

• Chronic Pain, Widespread
• Obesity
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
PROCEDURE	Bariatric Surgery	Participants will include people with chronic widespread pain who will undergo bariatric surgery. All participants will receive this intervention and will not be randomized to this or other interventions.

Timeline

• Start date: 2023-10-09
• Primary completion: 2027-09-01
• Completion: 2028-03-01
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

3 sites across 1 country: United States