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

Part of paid clinical trials in New York, New York.

Sponsor
New York University
Study ID
NCT06795386
Status
Recruiting
Apply to this trial

Conditions

  • Bariatric Surgery Candidate
  • Chronic Pain, Widespread
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 9, 2023
Status verified
Jan 2025
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
New York City Health + Hospitals/Bellevue HospitalNew YorkNew York10016
Manish Parikh, MD
[email protected]
212-562-3917
Moyra Rondon, LCSW
[email protected]
(212) 562-7311
Ericka N Merriwether, PT, DPT, PhD (PRINCIPAL_INVESTIGATOR)
Melanie Jay, MD, MS (SUB_INVESTIGATOR)
Sally Vanegas, PhD (SUB_INVESTIGATOR)
NYU CTSI Clinical Research CenterNew YorkNew York10016
Nurse Manager, RN, MA, CCRC
[email protected]
646-501-0637
NYU Steinhardt Arthur J. Nelson LaboratoryNew YorkNew York10010
Ericka N Merriwether, PT, DPT, PhD
[email protected]
212-998-9192

Find similar trials in New York, NY

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
New York City Health + Hospitals/Bellevue Hospital· New York, NYNYU CTSI Clinical Research Center· New York, NYNYU Steinhardt Arthur J. Nelson Laboratory· New York, NY

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