NCT06795386 Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
| NCT ID | NCT06795386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New York University |
| Condition | Chronic Pain, Widespread |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-09 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-10-09 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06795386 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Pain, Widespread. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06795386 currently recruiting?
Yes, NCT06795386 is actively recruiting participants. Contact the research team at em3766@nyu.edu for enrollment information.
Where is the NCT06795386 trial being conducted?
This trial is being conducted at New York, United States, New York, United States, New York, United States.
Who is sponsoring the NCT06795386 clinical trial?
NCT06795386 is sponsored by New York University. The trial plans to enroll 60 participants.
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