Association Between Body Composition and Pain in Spinal Cord Injury

University of Miami

Status: Enrolling

Conditions: Inflammatory Response; Pain

Treatments: Other: High Fat Meal; Other: Moderate Fat Meal

Study type: Interventional

Funder types: Other

Identifiers

NCT05459207

90SCIMS0013 (Other Grant/Funding Number)

20211078

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Moderate Fat Meal, Followed by High Fat Meal Group

Experimental group

Description:

Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.

Treatment:

Other: Moderate Fat Meal

Other: High Fat Meal

High Fat Meal, Followed by Moderate Fat Meal Group

Experimental group

Description:

Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.

Treatment:

Other: Moderate Fat Meal

Other: High Fat Meal