Association 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares how high-fat and moderate-fat meals affect signs of inflammation and sensitivity to pain in people with long-term spinal cord injuries. It also looks at how the amount of fat and other tissue in the body affects these responses.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–70 years old.
- Your spinal cord injury happened at least 2 years before joining the study.
- Your injury level is between C4 (the neck) and L2 (the lower back).
- Your injury is rated A–D on the AIS scale, which measures loss of movement and feeling.
- You speak English.
Who can't join
- You have trouble thinking or understanding that prevents you from understanding study risks, or you cannot give consent.
- You have a condition causing long-term inflammation throughout the body that is not related to body weight or fat. Examples include diseases where the immune system attacks the body, repeated or current urinary tract infections, or pressure sores worse than stage 2.
- You cannot have a DXA scan, an X-ray test that measures body fat and other tissue. For example, a leg joint is stuck bent more than 15 degrees.
- Blood cannot flow freely when drawn from a vein near the skin in your forearm or hand.
- You are pregnant.
- You are a prisoner.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
FL
- University of Miami · Coral Gables, FL 33146Elizabeth Felix, PhD · Study contact · 305-243-4497 · efelix@med.miami.eduElizabeth Felix, PhD · Principal investigatorMore trials in Coral Gables