Combined Circulatory and Dietary Interventions for Neuropathy

Conditions

• Diabete Type 2
• Neuropathy, Painful

Eligibility Criteria

Sex

ALL

Age

35 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• INF® Therapy — OTHER
  INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,
• NVIf — OTHER
  NVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens

Study Details

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.

Key Dates

Start date

Oct 1, 2026

Status verified

Sep 2025

Primary completion

Oct 1, 2028

Completion

Dec 1, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: INF® Therapy Only Group
  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.
• Experimental: NVIf Only Group
  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.
• Experimental: INF® Therapy + NVIf Group
  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.

Primary Outcome Measure

Change in Pain Intensity [ Time Frame: Baseline (Week 0) and post-intervention (Week 4-5) ]

Central Contacts

• Kyan Sahba, Post Doctoral Fellow, PhD
  9095586799
  [email protected]
• Mark Bussell, Clinical Director, DPT
  9095586799
  [email protected]

Locations (1)

Find similar trials in Loma Linda, CA