Recruiting

Observational Study

Sponsor:

New York University

Code:

NCT06795386

Conditions

Chronic Pain, Widespread

Obesity

Bariatric Surgery Candidate

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bariatric Surgery

Study Details

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.

Conditions

Chronic Pain, Widespread

Obesity

Bariatric Surgery Candidate

Study ID

NCT06795386

Start date

Oct 9, 2023

Status verified date

Jan, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Change in Pain Intensity at Rest as Assessed Using the Numeric Pain Rating Scale (NPRS) [ Time Frame: At baseline, 3 months (secondary endpoint), and 6 months (primary endpoint) post-surgery ]

Central Contacts and Locations

Central contacts

Ericka N Merriwether, PT, DPT, PhD

2129989192em3766@nyu.edu

Locations

NYU Steinhardt Arthur J. Nelson Laboratory

Recruiting

New York, New York, United States, 10010

Contacts

Ericka N Merriwether, PT, DPT, PhD

212-998-9192em3766@nyu.edu

New York City Health + Hospitals/Bellevue Hospital

Recruiting

New York, New York, United States, 10016

Contacts

Manish Parikh, MD

212-562-3917manish.parikh@bellevue.nychhc.org

Moyra Rondon, LCSW

(212) 562-7311rondonm1@nychhc.org

Principal Investigator:

Ericka N Merriwether, PT, DPT, PhD

NYU CTSI Clinical Research Center

Recruiting

New York, New York, United States, 10016

Contacts

Nurse Manager, RN, MA, CCRC

646-501-0637rosario.medina@nyulangone.org

More Information

Sponsor

New York University

Last update posted

Jan 28, 2025

Last verified

Jan, 2025

Keywords

  • chronic pain, adult obesity, pain equity, rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2025-01-28.