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

New York University (NYU)

Status: Enrolling

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

Treatments: Procedure: Bariatric Surgery

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06795386

1K23AR080846-01A1 (U.S. NIH Grant/Contract)

i21-01652

5K23AR080846-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Racialized adults with chronic widespread pain

Description:

Adults who self-identify as non-Hispanic Black and/or Hispanic/Latino by the U.S. Census have elected to undergo bariatric surgery. All study participants will undergo bariatric surgery as part of the standard of care for surgical weight loss and will not be randomized to any other placebo or control interventions for weight loss or pain.

Treatment:

Procedure: Bariatric Surgery