Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06795386

Recruiting nowNot applicableObservational

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionChronic Pain, Widespread, Obesity, Bariatric Surgery Candidate

Full registry criteria

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

Treatments and study arms

Bariatric Surgery

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.

Primary outcomes

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.