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

Recruiting

• Conditions: Chronic Pain, Widespread; Obesity; Bariatric Surgery Candidate

• Registration Number: NCT06795386
• Lead Sponsor: New York University

Brief 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.

Study Timeline

• Study Start: 2023-10-09
• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Primary Completion: 2027-09
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Self-identify as Black/African American or Hispanic/Latino ethnicity based on the U.S Census racial categories

• Eligible candidates for bariatric surgery (BMI greater than or equal to 40 or BMI greater than or equal to 35 with comorbidity

• Meets criteria for chronic widespread pain (CWP) based on the following:

  1. self-reported pain at 3 or more anatomical sites
  2. painful regions on both sides of the body
  3. self-reported pain intensity at rest of 3 out of 10 or higher using the Numeric Pain Rating Scale (NPRS) or equivalent

• Conversational language fluency in English or Spanish

• Able to give voluntary, written informed consent to participate

• Able to walk independently or with a cane prior to study enrollment

Exclusion Criteria

• Prospective participants with a previous history of bariatric surgery
• Have acute pain (pain for less than 6 weeks) at 1 month prior to study enrollment
• Have a systemic autoimmune disorder or immunodeficiency
• Have an unstable psychological condition
• Are non-ambulatory or ambulate with an assistive device other than a cane
• Pain localized to surgical sites at 3 months post-surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity at Rest as Assessed Using the Numeric Pain Rating Scale (NPRS)	At baseline, 3 months (secondary endpoint), and 6 months (primary endpoint) post-surgery	Participant-reported pain intensity at rest will be assessed post-surgery using the Numeric Pain Rating Scale (NPRS). The NPRS is an ordinal scale with scores ranging from 0-10. Zero is indicative of no pain and 10 indicates the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Change in Movement-Evoked Pain Intensity as Assessed Using the Numeric Pain Rating Scale (NPRS)	Baseline, 6 months post-surgery	Participant-reported pain during functional movement tasks will be assessed using the Numeric Pain Rating Scale (NPRS). The NPRS is an ordinal scale with scores ranging from 0-10. Zero is indicative of no pain and 10 indicates the worst pain imaginable.

Trial Locations

Locations (3)

NYU Steinhardt Arthur J. Nelson Laboratory; 🇺🇸 New York, New York, United States

New York City Health + Hospitals/Bellevue Hospital; 🇺🇸 New York, New York, United States

NYU CTSI Clinical Research Center; 🇺🇸 New York, New York, United States