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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Coral Gables, Florida, United States
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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