NCT05459207 Association Between Body Composition and Pain in Spinal Cord Injury
| NCT ID | NCT05459207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-02-20 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Elizabeth Felix, PhD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT05459207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05459207 currently recruiting?
Yes, NCT05459207 is actively recruiting participants. Contact the research team at efelix@med.miami.edu for enrollment information.
Where is the NCT05459207 trial being conducted?
This trial is being conducted at Coral Gables, United States.
Who is sponsoring the NCT05459207 clinical trial?
NCT05459207 is sponsored by University of Miami. The principal investigator is Elizabeth Felix, PhD at University of Miami. The trial plans to enroll 40 participants.