RECRUITING

Association Between Body Composition and Pain in Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purposes of the study are to quantify and compare relationships among acute changes in inflammatory markers and evoked pain sensitivity after a high-fat meal (HFM) challenge, compared to a moderate-fat meal challenge, and explore the influence of body composition on these responses, in individuals with chronic spinal cord injury

Official Title

Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury

Quick Facts

Study Start:2023-02-20
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05459207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-65 years
  2. * SCI occurring at least 2 years prior to study entry
  3. * Neurological level of injury (LOI) between C4 and L2
  4. * American Spinal Injury Association Impairment Scale (AIS) A-D
  5. * English-speaking.
  1. * Cognitive dysfunction that limits ability to adequately understand the risks of the study or are otherwise unable to consent
  2. * Health conditions associated with chronic systemic inflammation unrelated to weight or adiposity (e.g., systemic autoimmune diseases, recurrent or active urinary tract infection, pressure injury \> Stage 2)
  3. * Conditions that preclude measurement of body composition by dual-energy x-ray absorptiometry (DXA; e.g., lower limb contracture \> 15 degrees)
  4. * Inability to obtain free-flowing blood from a superficial forearm or hand vein
  5. * Pregnant women
  6. * Prisoners

Contacts and Locations

Study Contact

Elizabeth Felix, PhD
CONTACT
305-243-4497
efelix@med.miami.edu

Principal Investigator

Elizabeth Felix, PhD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Coral Gables, Florida, 33146
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Elizabeth Felix, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-20
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-02-20
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pain
  • Inflammatory Response