SCI - Spinal Cord InjuryNCT07179588
Nutrition and Pain Study
A study testing Nutrition Education Program and Nutrition Counseling in people with SCI - Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Nutrition Education Program and Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Intervention to Reduce Pain in Spinal Cord Injury
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
- Being tested
- Nutrition Education Program, Nutrition Counseling
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education ProgramBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Group | Experimental | Participants will be in this group for up to 4 months. Receives: Behavioral: Nutrition Education Program; Behavioral: Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, 4-months (after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start19 Nov 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Spinal Cord Injury Professionals, Inc.
- Responsible party
- Principal investigator, Elizabeth Felix, University of Miami
- Investigators
- Elizabeth Felix, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179588
- Sponsor's protocol ID
- 20250188
- Status last verified
- Mar 2026
- First submitted
- 16 Sep 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention to Reduce Pain in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07179588
- Acronym / sponsor ID
- 20250188
- Conditions
- SCI - Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Academy of Spinal Cord Injury Professionals, Inc.
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Group | Experimental | Behavioral: Nutrition Education Program, Behavioral: Nutrition CounselingParticipants will be in this group for up to 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Education ProgramThe 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. | Behavioural | Nutrition Group |
| Nutrition CounselingParticipant 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. | Behavioural | Nutrition Group |
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Felix, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education Program and Nutrition Counseling in people with SCI - Spinal Cord Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain rating as measured by the Numerical Rating Scale (time frame: Baseline, 4-months (after intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.