Nutrition and Pain Study

NCT07179588 | Active Not Recruiting

• 1 other identifier: 20250188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

SCI - Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• Change in pain rating as measured by the Numerical Rating Scale

  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.

  Baseline, 4-months (after intervention)

• Change in neuropathic pain severity as measured by the Neuropathic Pain Symptom Inventory

  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).

  Baseline, 4-months (after intervention)

Study Arms (1)

Nutrition Group

EXPERIMENTAL

Participants will be in this group for up to 4 months.

Behavioral: Nutrition Education Program; Behavioral: Nutrition Counseling

Interventions

Nutrition Education Program BEHAVIORAL

The participants will attend a monthly nutrition education session for 4 months (total 4 sessions). The sessions will be available in person and over teleconference platforms (i.e., Zoom). Each session will be up to 1-hour, which will include nutrition guidelines to manage diet quality.

Nutrition Group

Nutrition Counseling BEHAVIORAL

Participant will meet with a registered dietitian for one-on-one diet consults once a month for 4 months. These sessions can be in-person or via Zoom. Each session will be up to 1 hour, and will be done to assess if the nutrition guidelines taught during the education sessions are being implemented.

Nutrition Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Adults unable to consent Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women (self-report)
• Prisoners

Sponsors & Collaborators

• University of Miami: lead
• Academy of Spinal Cord Injury Professionals, Inc.: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Elizabeth Felix, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 18, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)