Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNew York University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
self-reported pain at 3 or more anatomical sites
painful regions on both sides of the body
Disqualifiers
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
Trial population
New York City Health + Hospitals/Bellevue Hospital Center Bariatric Surgery Clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bariatric Surgery
Procedure/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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Racialized adults with chronic widespread pain1 intervention
Trial outcomes
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.
Time frame
At baseline, 3 months (secondary endpoint), and 6 months (primary endpoint) post-surgerySecondary 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.
Time frame
Baseline, 6 months post-surgeryOther outcomes
1
Mean Body Weight at Baseline
Body Weight will be measured in kilograms using a digital scale. Two measurements will be taken. A third measurement will be taken if these measurements differ by 0.5 kg or more. The average of the measurements will be included in all statistical analyses.
Time frame
Baseline (pre-surgery)2
Mean Body Weight at 3 Months Post-surgery
Participant-reported body weight measured in kilograms.
Time frame
3 Months Post-surgery3
Mean Body Weight at 6 Months Post-surgery
Body Weight will be measured in kilograms using a digital scale. Two measurements will be taken. A third measurement will be taken if these measurements differ by 0.5 kg or more. The average of the measurements will be included in all statistical analyses.
Time frame
6 Months Post-surgery4
Height - Standing Height at Baseline
Standing height will be measured using a stadiometer from the crown of the participant's head to the lowest point on their heels. Two measurements of standing height will be taken in centimeters. A third measurement will be taken if these measurements differ by 1.0 or more. The average of the measurements will be used in all statistical analyses.
Time frame
Baseline (pre-surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
New York University
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov