Association Between Body Composition and Pain in Spinal Cord Injury

Pain Clinical Trial

Official title:

Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459207
• Other study ID #: 20211078
• Secondary ID: 90SCIMS0013
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Elizabeth Felix, PhD
• Phone: 305-243-4497
• Email: efelix[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years

• SCI 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

Related Conditions & MeSH terms

• Inflammatory Response
• Pain
• Spinal Cord Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak change in Interleukin (IL)-6	analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter	at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Primary	peak change in evoked pain sensitivity	measures of heat pain threshold (degrees Celcius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge	at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Secondary	correlation coefficient between changes in IL-6 and evoked pain sensitivity	correlation coefficient for relationship between changes in IL-6 and heat pain thresholds across time	at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion