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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-09

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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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

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Chronic Pain, Widespread Obesity Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Racialized adults with chronic widespread pain

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.

Bariatric Surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No