Clinical trial NCT06795386: Chronic Widespread Pain After Rapid Weight Loss in Non-Hispanic Black and Hispanic/Latino/a/x Adults
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain, Widespread
Obesity
Bariatric Surgery Candidate
Keywords: chronic pain, adult obesity, pain equity, rehabilitation
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2025-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New York City Health + Hospitals/Bellevue Hospital Center Bariatric Surgery Clinic

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.

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.

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

Primary outcomes:
measure: Change in Pain Intensity at Rest as Assessed Using the Numeric Pain Rating Scale (NPRS)
timeFrame: At baseline, 3 months (secondary endpoint), and 6 months (primary endpoint) post-surgery
Secondary outcomes:
measure: Change in Movement-Evoked Pain Intensity as Assessed Using the Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 6 months post-surgery
Other outcomes:
measure: Mean Body Weight at Baseline
timeFrame: Baseline (pre-surgery)
measure: Mean Body Weight at 3 Months Post-surgery
timeFrame: 3 Months Post-surgery
measure: Mean Body Weight at 6 Months Post-surgery
timeFrame: 6 Months Post-surgery
measure: Height - Standing Height at Baseline
timeFrame: Baseline (pre-surgery)
measure: Waist Circumference at Baseline
timeFrame: Baseline (pre-surgery)
measure: Waist Circumference at 6 Months Post-Surgery
timeFrame: 6 Months Post-surgery
measure: Body Mass Index (BMI) at Baseline
timeFrame: Baseline (pre-surgery)
measure: Body Mass Index (BMI) at 3 Months Post-Surgery
timeFrame: 3 Months Post-surgery
measure: Body Mass Index (BMI) at 6 Months Post-surgery
timeFrame: 6 Months Post-surgery
measure: Percentage of Total Weight Loss (%TWL) at 3 Months Post-Surgery
timeFrame: 3 Months Post-surgery
measure: Percentage of Total Weight Loss (%TWL) at 6 Months Post-Surgery
timeFrame: 6 Months Post-surgery
measure: Knee Joint Range of Motion Using Goniometry at Baseline
timeFrame: Baseline (pre-surgery)
measure: Knee Joint Range of Motion Using Goniometry at 6 Months Post-Surgery
timeFrame: 6 Months Post-surgery
measure: Lumbar Spine Range of Motion at Baseline
timeFrame: Baseline (pre-surgery)
measure: Lumbar Spine Range of Motion at 6 Months Post-surgery
timeFrame: 6 Months Post-surgery
measure: Physical Function as Assessed Using the Six-Minute Walk Test (6MWT) at Baseline
timeFrame: Baseline (pre-surgery)
measure: Physical Function as Assessed Using the Six-Minute Walk Test (6MWT) at 6 Months Post-surgery
timeFrame: 6 Months Post-surgery
measure: Physical Function as Assessed Using the Five Time Sit-to-Stand Test (FTSTS) at 6 Months Post-Surgery
timeFrame: 6 Months Post-surgery
measure: Physical Function as Assessed Using the Five Time Sit-to-Stand Test (FTSTS) at Baseline
timeFrame: Baseline (pre-surgery)
measure: Pain Sensitivity as Assessed Using Pressure Pain Threshold at Baseline
timeFrame: Baseline (pre-surgery)
measure: Pain Sensitivity as Assessed Using Pressure Pain Threshold at 6M Post-surgery
timeFrame: 6 Months Post-surgery
measure: Pain Sensitivity as Assessed Using Conditioned Pain Modulation at Baseline
timeFrame: Baseline (pre-surgery)
measure: Pain Sensitivity as Assessed Using Conditioned Pain Modulation at 6M Post-surgery
timeFrame: 6 Months Post-surgery
measure: Pain Sensitivity as Assessed Using Temporal Summation at 6M Post-surgery
timeFrame: 6 Months Post-surgery
measure: Pain Sensitivity as Assessed Using Temporal Summation at Baseline
timeFrame: Baseline
measure: Pain Intensity and Interference as Assessed Using the Brief Pain Inventory Short Form (BPI-SF) at Baseline
timeFrame: Baseline (pre-surgery)
measure: Pain Intensity and Interference as Assessed Using the Brief Pain Inventory Short Form (BPI-SF) at 3 Months Post-surgery
timeFrame: 3 Months Post-surgery
measure: Pain Intensity and Interference as Assessed Using the Brief Pain Inventory Short Form (BPI-SF) at 6 Months Post-surgery
timeFrame: 6 Months Post-surgery
Locations:
city: New York
country: United States
facility: NYU Steinhardt Arthur J. Nelson Laboratory
state: New York
city: New York
country: United States
facility: New York City Health + Hospitals/Bellevue Hospital
state: New York
city: New York
country: United States
facility: NYU CTSI Clinical Research Center
state: New York
Study officials:
References: