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Nutrition and Pain Study

Dietary Intervention to Reduce Pain in Spinal Cord Injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07179588
Enrollment
30
Registered
2025-09-18
Start date
2025-11-19
Completion date
2027-06-01
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCI - Spinal Cord Injury

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).

Interventions

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.

BEHAVIORALNutrition Counseling

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.

Sponsors

University of Miami
Lead SponsorOTHER
Academy of Spinal Cord Injury Professionals, Inc.
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in pain rating as measured by the Numerical Rating ScaleBaseline, 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 InventoryBaseline, 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORElizabeth Felix, PhD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026