Combined Circulatory and Dietary Interventions for Neuropathy
CDIN
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the effectiveness of three different interventions in improving neuropathy symptoms in individuals aged 35-85 with moderate to severe neuropathy. The study will compare three treatment groups: Intraneural Facilitation® (INF®) therapy alone, INF® therapy combined with Neuro vascular index (NVI) food-guided elimination (NVIf), and NVIf alone. The aim is to determine which treatment results in the greatest improvement in neuropathy symptoms, including quality of life, sensory and pain improvements, and functional outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2025
CompletedFirst Posted
Study publicly available on registry
October 9, 2025
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
Study Completion
Last participant's last visit for all outcomes
December 1, 2028
October 9, 2025
September 1, 2025
2 years
September 25, 2025
October 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in Pain Intensity
Pain intensity will be assessed using the Visual Analog Scale. Improvement will be indicated by reduced VAS scores. Unit of Measure: Millimeters on a 0-100 mm scale.
Baseline (Week 0) and post-intervention (Week 4-5)
Change in Sensory Function
Sensory function will be assessed using the Semmes-Weinstein Monofilament test. Improvement will be indicated by increased monofilament detection. Detection threshold in grams (monofilament response: detected/not detected)
Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)
Change in Functional Limitation
Functional limitation related to neuropathy will be assessed using the Lower Extremity Functional Scale. Improvement will be indicated by higher Lower Extremity Functional Scale scores. Scale score (0-80).
Baseline (Week 0) and post-intervention (Week 4-5)
Change in Gait Speed
Gait speed will be assessed using the 10-Meter Walk Test. Improvement will be indicated by faster walk time. Seconds to complete 10 meters (converted to meters/second if applicable)
Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)
Change in Mobility and Fall Risk
Mobility and fall risk will be assessed using the Timed Up and Go (TUG) test. Improvement will be indicated by shorter completion times. Unit of Measure: Seconds.
Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)
Secondary Outcomes (1)
Change in Quality of Life
Baseline (Week 0) and post-intervention (Week 4-5)
Other Outcomes (1)
Change in Neurovascular Function and Inflammation
Baseline (Week 0) and post-intervention (Week 4-5)
Study Arms (3)
INF® Therapy Only Group
EXPERIMENTALINF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner. Participants will receive 60-minute sessions, 2-3 times per week, for a total of 8 sessions.
NVIf Only Group
EXPERIMENTALNVIf, is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens. By identifying foods that exacerbate inflammation and restrict circulation, the intervention guides patients to eliminate these foods, thereby improving nerve health. Those in this group will participate in follow-up for food elimination adherence, including daily tracking of foods ingested. Week 1-2: 4 x NVI food guided-elimination visits. Week 2-5 complete weekly Likert scale inquiring about food eliminations and weekly phone call check-in attempts will be made by research staff.
INF® Therapy + NVIf Group
EXPERIMENTALINF® therapy and NVI Food-Guided Elimination Group: Week 1-2: 4 x NVI food guided-elimination visits. Participants will receive 60-minute sessions, 2-3 times per week, for a total of 8 sessions. As well as participate in NVIf, which is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens. By identifying foods that exacerbate inflammation and restrict circulation, the intervention guides patients to eliminate these foods, thereby improving nerve health. Those in this group will participate in follow-up for food elimination adherence, including daily tracking of foods ingested. Week 2-5 complete weekly Likert scale inquiring about food eliminations and weekly phone call check-in attempts will be made by research staff as well as INF® therapy for 60-minute sessions, 2-3 times per week, for a total of 8 sessions.
Interventions
INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,
NVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of peripheral neuropathy in the lower extremities by a physician
- Lower Extremity Functional Scale (LEFS) score between 0-60 (indicating moderate to significant difficulty in lower extremity function)
- Ability to speak and understand English
- Ability to provide appropriate written informed consent
- Willingness to participate in all study procedures, including the intervention and follow-up visits
- Ability to ambulate independently with or without an assistive device
You may not qualify if:
- Any medical condition suggesting potential decline in function over the next 6 months (e.g., ongoing chemotherapy, radiation therapy, or dialysis)
- Active alcohol or drug misuse
- End-stage renal failure
- Uncontrolled hypertension
- Severe dyslipidemia
- Chronic liver disease
- Autoimmune disease
- Advanced chronic obstructive pulmonary disease (COPD)
- Active inflammation
- Shingles-related neuropathy
- Presence of any lower extremity amputations or significant wounds
- Severe chronic medical conditions requiring active treatment that could interfere with study outcomes
- Morbid obesity
- Concomitant use of medications or devices that may interfere with study results or are not allowed per protocol
- Inability to comprehend or provide informed consent
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neuropathic Therapy Center
Loma Linda, California, 92354-0200, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyan Sahba, PhD
Loma Linda University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This study uses an open-label design with no masking; both participants and study personnel will know the assigned treatment group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Invetigator
Study Record Dates
First Submitted
September 25, 2025
First Posted
October 9, 2025
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
October 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
No plan to share individual participant data (IPD). De-identified aggregate data may be made available upon reasonable request to the Principal Investigator, following study completion and publication of primary results, in accordance with institutional policies and IRB approval.