Examining chronic pain improvement after weight loss surgery in specific ethnic groups

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

This study is testing if weight loss surgery can help reduce chronic pain in Hispanic/Latino and non-Hispanic Black adults with higher body weight.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: New York University (other)
• Locations: 3 sites (New York, New York and 2 other locations)
• Trial ID: NCT06795386 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate whether surgical weight loss can alleviate chronic widespread pain in adults who identify as Hispanic/Latino or non-Hispanic Black and have a higher BMI. Researchers will assess pain at rest and movement-evoked pain before and six months after bariatric surgery, alongside evaluating changes in pain processing and joint function. The study will involve two in-person visits and one remote visit for data collection, including pain surveys and health questionnaires. The central hypothesis is that pain will decrease post-surgery, potentially mediated by improved pain modulation and joint function.

Who should consider this trial

Good fit: Ideal candidates are adults who self-identify as Black/African American or Hispanic/Latino, have a BMI of 35 or higher, and experience chronic widespread pain.

Not a fit: Patients with a history of bariatric surgery or those experiencing acute pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective pain management strategies for individuals with obesity and chronic pain in these ethnic groups.

How similar studies have performed: While similar studies have explored the relationship between weight loss and pain, this specific focus on ethnic disparities in pain management is relatively novel.

Eligibility 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

Where this trial is running

New York, New York and 2 other locations

• NYU Steinhardt Arthur J. Nelson Laboratory — New York, New York, United States (RECRUITING)
• New York City Health + Hospitals/Bellevue Hospital — New York, New York, United States (RECRUITING)
• NYU CTSI Clinical Research Center — New York, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Ericka N Merriwether, PT, DPT, PhD

Conditions: Chronic Pain, Widespread, Obesity, Bariatric Surgery Candidate, chronic pain, adult obesity, pain equity, rehabilitation