Exploring the link between body composition and pain in spinal cord injury
Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Coral Gables, Florida) |
| Trial ID | NCT05459207 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Coral Gables, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.