NCT07213843|Not Yet Recruiting
Combined Circulatory and Dietary Interventions for Neuropathy
CDIN
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CDIN
Sponsor study identifier
interventional
60
1 country
1
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2025
Actual (reported)October 9, 2025
Actual (reported)October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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 Quality of Life
Baseline (Week 0) and post-intervention (Week 4-5)
Change in Neurovascular Function and Inflammation
Baseline (Week 0) and post-intervention (Week 4-5)
INF® 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, 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 is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,
Neuropathic Therapy Center
Loma Linda, California, 92354-0200, United States
Kyan Sahba, PhD
Loma Linda University
First Submitted
September 25, 2025
First Posted
October 9, 2025
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
INF® 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.
NVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens
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Primary Completion
October 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 9, 2025
Record last verified: 2025-09
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.
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Source: ClinicalTrials.gov.
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