Chronic Pain, WidespreadNCT06795386
Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
An observational study of Chronic Pain, Widespread and Obesity, run by New York University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Widespread, Obesity, Bariatric Surgery Candidate
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Oct 2023to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: New York City Health + Hospitals/Bellevue Hospital Center Bariatric Surgery Clinic
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
NYU Steinhardt Arthur J. Nelson Laboratory
New York, New York, 10010
Ericka N Merriwether, PT, DPT, PhD, 212-998-9192, em3766@nyu.edu
- Recruiting
New York City Health + Hospitals/Bellevue Hospital
New York, New York, 10016
Manish Parikh, MD, 212-562-3917, manish.parikh@bellevue.nychhc.org
Moyra Rondon, LCSW, (212) 562-7311, rondonm1@nychhc.org
- Recruiting
NYU CTSI Clinical Research Center
New York, New York, 10016
Nurse Manager, RN, MA, CCRC, 646-501-0637, rosario.medina@nyulangone.org
About this study
Official title: Determining Mechanisms of Pain Reduction in Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
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:
- Do pain at rest (primary outcome) and movement-evoked pain (secondary outcome) improve after bariatric surgery?
- Do pain processing and joint function change after bariatric surgery?
- 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.
Read the detailed description
The central hypothesis that will be tested is that pain at rest (primary outcome) and movement-evoked pain (MEP, secondary outcome) will decrease after bariatric surgery. We will also determine if pain reduction will be mediated by improved pain modulation and select joint motion and loading variables. The study will feature a prospective, observational quasi-experimental cohort study design for within-group analyses of pain at rest and MEP using the Numeric Pain Rating Scale (NPRS) and other exploratory outcomes before and 6 months after bariatric surgery. Pain at rest and MEP at 3 months after bariatric surgery are secondary endpoints. All participants will attend two in-person study visits and one off-site (remote) visit. Laboratory-based measurement and evaluation of pain and weight loss will be conducted during two in-person visits 1-3 months before bariatric surgery (Visit 1) at 6 months (Visit 3, primary endpoint). Pain surveys, weight measurements, and health questionnaires will be administered online or via telephone 3 months after surgery to assess acute post-surgical pain, weight loss, and other secondary and exploratory health outcomes (Visit 2). Descriptive analyses of all data will be performed by the NYU Biostatistics Resource directed by Dr. Huilin Li.
- Being tested
- Bariatric Surgery
- Keywords
- chronic pain, adult obesity, pain equity, rehabilitation
- Medical subject headings
- Chronic Pain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Participant-reported pain during functional movement tasks will be assessed 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.
Measured: Baseline, 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start9 Oct 2023
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain, WidespreadStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795386
- Sponsor's protocol ID
- i21-01652
- Other IDs
- 1K23AR080846-01A1, 5K23AR080846-02
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Since we are working with a document-diverse population, we will consult with university and local officials to determine the most appropriate course of action.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Mechanisms of Pain Reduction in Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
- ClinicalTrials.gov ID
- NCT06795386
- Acronym / sponsor ID
- i21-01652
- Keywords
- chronic pain, adult obesity, pain equity, rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do pain at rest (primary outcome) and movement-evoked pain (secondary outcome) improve after bariatric surgery?
- Do pain processing and joint function change after bariatric surgery?
- 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.
Detailed description
The central hypothesis that will be tested is that pain at rest (primary outcome) and movement-evoked pain (MEP, secondary outcome) will decrease after bariatric surgery. We will also determine if pain reduction will be mediated by improved pain modulation and select joint motion and loading variables. The study will feature a prospective, observational quasi-experimental cohort study design for within-group analyses of pain at rest and MEP using the Numeric Pain Rating Scale (NPRS) and other exploratory outcomes before and 6 months after bariatric surgery. Pain at rest and MEP at 3 months after bariatric surgery are secondary endpoints. All participants will attend two in-person study visits and one off-site (remote) visit. Laboratory-based measurement and evaluation of pain and weight loss will be conducted during two in-person visits 1-3 months before bariatric surgery (Visit 1) at 6 months (Visit 3, primary endpoint). Pain surveys, weight measurements, and health questionnaires will be administered online or via telephone 3 months after surgery to assess acute post-surgical pain, weight loss, and other secondary and exploratory health outcomes (Visit 2). Descriptive analyses of all data will be performed by the NYU Biostatistics Resource directed by Dr. Huilin Li.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Racialized adults with chronic widespread pain | – | Procedure: Bariatric SurgeryAdults 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New York City Health + Hospitals/Bellevue Hospital Center Bariatric Surgery Clinic
Key inclusion criteria (9 listed)
- 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:
- Conversational language fluency in English or Spanish
- Able to give voluntary, written informed consent to participate
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryParticipants 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. | Procedure or surgery | Racialized adults with chronic widespread pain |
Primary outcome
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
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.
1 secondary outcome
Change in Movement-Evoked Pain Intensity as Assessed Using the Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided. Since we are working with a document-diverse population, we will consult with university and local officials to determine the most appropriate course of action.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, Widespread and Obesity, run by New York University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ericka N Merriwether, PT, DPT, PhD (2129989192, em3766@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.