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

NCT06795386 | Recruiting

• 3 other identifiers: i21-016521K23AR080846-01A15K23AR080846-02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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. 1.Do pain at rest (primary outcome) and movement-evoked pain (secondary outcome) improve after bariatric surgery?
2. 2.Do pain processing and joint function change after bariatric surgery?
3. 3.Are pain processing and joint function associated with clinically significant pain change after surgical weight loss?

Conditions

Chronic Pain, Widespread; Obesity; Bariatric Surgery Candidate

Keywords

chronic pain, adult obesity, pain equity, rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity at Rest as Assessed Using the Numeric Pain Rating Scale (NPRS)

  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.

  At baseline, 3 months (secondary endpoint), and 6 months (primary endpoint) post-surgery

Secondary Outcomes (1)

• Change in Movement-Evoked Pain Intensity as Assessed Using the Numeric Pain Rating Scale (NPRS)

  Baseline, 6 months post-surgery

Other Outcomes (28)

• Mean Body Weight at Baseline

  Baseline (pre-surgery)

• Mean Body Weight at 3 Months Post-surgery

  3 Months Post-surgery

• Mean Body Weight at 6 Months Post-surgery

  6 Months Post-surgery

Study Arms (1)

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.

Procedure: Bariatric Surgery

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.

Racialized adults with chronic widespread pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New York City Health + Hospitals/Bellevue Hospital Center Bariatric Surgery Clinic

You may qualify if:

• 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:
• self-reported pain at 3 or more anatomical sites
• painful regions on both sides of the body
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (3)

NYU Steinhardt Arthur J. Nelson Laboratory

New York, New York, 10010, United States

RECRUITING

New York City Health + Hospitals/Bellevue Hospital

New York, New York, 10016, United States

RECRUITING

NYU CTSI Clinical Research Center

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Ericka N Merriwether, PT, DPT, PhD

CONTACT

2129989192; em3766@nyu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: October 9, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (3)