Exploring the link between body composition and pain in 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
Run by University of Miami · NCT05459207 · Data updated 2026-11-12
This study is testing how different types of meals affect pain and inflammation in people with spinal cord injuries to see if body composition plays a role.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Coral Gables, Florida) |
| Status | Recruiting |
| Started | February 20, 2023 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT05459207 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with a spinal cord injury occurring at least 2 years prior, with specific neurological levels of injury.
✕Probably not a fit
Patients with cognitive dysfunction, chronic systemic inflammation unrelated to weight, or conditions preventing body composition measurement may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how body composition affects pain sensitivity and inflammatory responses in individuals with chronic spinal cord injury after consuming meals with different fat content. Participants will undergo a high-fat meal challenge and a moderate-fat meal challenge to measure acute changes in inflammatory markers and pain sensitivity. The study aims to quantify and compare these responses to better understand the relationship between diet, body composition, and pain in this population.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations and pain management strategies for individuals with spinal cord injuries.
How similar studies have gone: While the specific approach of this study may be novel, similar studies exploring the relationship between diet and pain in other populations have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 years * Spinal cord injury 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
Where it's running
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University of Miami
Coral Gables, Florida, United States Recruiting
Study contacts
- Principal investigator: Elizabeth Felix, PhD — University of Miami
- Study coordinator: Elizabeth Felix, PhD
- Email: efelix@med.miami.edu
- Phone: 305-243-4497
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.