An interventional study of INF® Therapy and NVIf in Diabete Type 2 and Neuropathy, Painful, sponsored by Loma Linda University. Not yet recruiting at 1 site in United States. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
The purpose of this investigator-initiated study is to observe the effectiveness of a manual physical therapy technique known as Intraneural Facilitation (INF®), both independently and in combination with a Nutritional Vascular Inflammation focused (NVIf) dietary intervention, in improving neurovascular function, pain, and physical performance in individuals with moderate to severe peripheral neuropathy (PN). Subjects will be randomized into one of the three interventions arms: (1) INF® therapy alone, (2) NVIf intervention alone or (3) a combination of both. INF® is a manual therapy, while NVIf utilizes ultrasound guided food elimination. Outcomes include pain (Visual analog scale), sensory function (Semmes Weinstein Monofilament), physical function (Lower extremity functional scale, 10-meter walk test, timed up and go) quality of life (Norfolk Quality of life-Diabetic neuropathy), and neurovascular blood flow analysis. Study participants will be 35-85 years old with a physician-confirmed diagnosis of moderate to severe lower extremity peripheral neuropathy and at least one symptom: numbness, tingling, burning, sharp pain, or increased sensitivity. They must score 0-60 on the Lower Extremity Functional Scale (LEFS), speak and understand English, provide written informed consent, and be willing to complete all study procedures, including intervention and follow-up visits. Participants must be able to ambulate independently with or without an assistive device. Subjects will be recruited using email and flyer through the Neuropathic Therapy Center (NTC) research interest list and through providers at Loma Linda's University (LLU) Health offices. 60 subjects will be recruited, and consent will take place at the LLU or at the Murrieta study site prior to randomization, administered by trained study staff authorized to obtain informed consent.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
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Exclusion Criteria
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.
Other: INF® Therapy
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.
Other: NVIf
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.
Other: INF® Therapy · Other: NVIf
INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,
Also known as: Intranerual Facilitation
NVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens
Also known as: Neuro vascular index food-guided elimination
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.
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)
Change in Quality of Life
Quality of life will be measured using the Norfolk Quality of Life-Diabetic Neuropathy questionnaire to determine the effect of each treatment approach on overall patient well-being. Higher scores indicate greater impairment; a reduction reflects improved quality of life. Lowest score=0, means best quality of life with little to no neuropathy impacts. A maximum score of 138, means worst quality of life with severe impairments.
Time frame: Baseline (Week 0) and post-intervention (Week 4-5)
Change in Neurovascular Function and Inflammation
Mechanistic analysis will be performed using the Neurovascular Index with Philips Affinity 50 Ultrasound to evaluate changes in microvascular resistance and neurovascular blood flow, as well as the effect of NVI-guided food elimination on reducing neurovascular inflammation.
Time frame: Baseline (Week 0) and post-intervention (Week 4-5)
Plan to share: No — 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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