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Active, Not Recruiting

NCT Number: NCT07179588

Nutrition and Pain Study

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

SCI - Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 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.

Primary outcomes

  1. Change in pain rating as measured by the Numerical Rating Scale

    Time frame: 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.

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Academy of Spinal Cord Injury Professionals, Inc.

Registry information

Official study title

Dietary Intervention to Reduce Pain in Spinal Cord Injury

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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