Association Between Body Composition and Pain in Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Moderate Fat Meal
- High Fat Meal
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov