Nutrition and Pain Study

Not Applicable

Not yet recruiting

• Conditions: SCI - Spinal Cord Injury

• Registration Number: NCT07179588
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this research is to assess the effectiveness of a nutrition intervention on diet quality in managing pain in individuals with spinal cord injury (SCI).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-12-01
• Primary Completion: 2027-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults (≥18 y)
• With SCI (motor complete or incomplete American Spinal Injury Association Impairment Scale (AIS) A-D, paraplegia or ventilator-independent tetraplegia)
• Have chronic pain

Exclusion Criteria

• Adults unable to consent Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women (self-report)
• Prisoners
• Those not meeting inclusion criteria will be excluded (e.g., no pain).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in pain rating as measured by the Numerical Rating Scale	Baseline, 4-months (after intervention)	The primary pain outcome will be measured using a 0 to 10 numerical rating scale (NRS) of average pain intensity during the past week, with higher scores indicating higher pain intensity.
Change in neuropathic pain severity as measured by the Neuropathic Pain Symptom Inventory	Baseline, 4-months (after intervention)	Neuropathic pain severity outcome will be measured using the Neuropathic Pain Symptom Inventory (NPSI; 0-100) with higher scores indicating greater pain levels. This neuropathic pain rating will be captured at baseline and after the intervention period (4 months).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States