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Search / Trial NCT05459207

Association Between Body Composition and Pain in Spinal Cord Injury

Launched by UNIVERSITY OF MIAMI · Jul 11, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the connection between body composition and pain in individuals with spinal cord injuries (SCI). Specifically, the researchers want to understand how a high-fat meal affects inflammation and pain sensitivity compared to a moderate-fat meal. They are looking for participants who are between 18 and 65 years old, have had a spinal cord injury for at least two years, and can speak English. Participants should have a specific level of injury (between C4 and L2) and a certain score on a scale that measures the impact of the injury.

If you decide to participate, you'll be asked to eat different types of meals while researchers monitor your body’s responses, such as inflammation levels and how sensitive you are to pain. It’s important to note that people with certain health conditions or who cannot provide informed consent will not be eligible. This trial is currently recruiting participants, and it's an opportunity to contribute to important research that may help improve pain management for those with spinal cord injuries.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18-65 years
  • SCI occurring at least 2 years prior to study entry
  • Neurological level of injury (LOI) between C4 and L2
  • American Spinal Injury Association Impairment Scale (AIS) A-D
  • English-speaking.
  • Exclusion Criteria:
  • Cognitive dysfunction that limits ability to adequately understand the risks of the study or are otherwise unable to consent
  • 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)
  • Conditions that preclude measurement of body composition by dual-energy x-ray absorptiometry (DXA; e.g., lower limb contracture \> 15 degrees)
  • Inability to obtain free-flowing blood from a superficial forearm or hand vein
  • Pregnant women
  • Prisoners

About University Of Miami

The University of Miami, a leading academic institution, is dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence in education and research, the university fosters collaboration among multidisciplinary teams to explore new therapies and treatment modalities. Its extensive clinical programs are supported by state-of-the-art facilities and a diverse patient population, enabling the exploration of cutting-edge solutions to complex health challenges. The University of Miami is poised to contribute significantly to the field of medicine through its rigorous scientific inquiry and a steadfast commitment to ethical research practices.

Locations

Coral Gables, Florida, United States

Patients applied

0 patients applied

Trial Officials

Elizabeth Felix, PhD

Principal Investigator

University of Miami

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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