Association Between Body Composition and Pain in Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderate Fat Meal, High Fat Meal.
- Who it may be relevant to
- Registry conditions: Pain, Inflammatory Response. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury
Overview
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
Interventions
- Other Moderate Fat Meal
A liquid meal consisting of powdered protein and complex carbohydrates blended with coconut oil and peanut butter in ratios required to achieve the desired calorie and macronutrient distributions of a normal/moderate fat meal. - Other High Fat Meal
A liquid meal consisting of powdered protein and complex carbohydrates blended with coconut oil and peanut butter in ratios required to achieve the desired calorie and macronutrient distributions of a high-fat meal.
Primary outcome measures
- peak change in Interleukin (IL)-6 [Time frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion]
- peak change in evoked pain sensitivity [Time frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion]
Secondary outcome measures (1)
- correlation coefficient between changes in IL-6 and evoked pain sensitivity [Time frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Miami — Coral Gables
Identifiers
NCT: NCT05459207 · 20211078 · 90SCIMS0013