Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)

Loma Linda University (LLU)

Status: Begins enrollment in 7 months

Conditions: Neuropathy, Painful; Diabete Type 2

Treatments: Other: INF® Therapy; Other: NVIf

Study type: Interventional

Funder types: Other

Identifiers

NCT07213843

5250381

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Inability to speak or understand English
• Pregnancy, breastfeeding, or planning pregnancy during the study period (female participants)
• Inability or unwillingness to adhere to study procedures, including dietary guidelines or follow-up visits
• Inability to complete all required study assessments, including follow-up appointments and questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

INF® Therapy Only Group

Experimental group

Description:

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.

Treatment:

Other: INF® Therapy

NVIf Only Group

Experimental group

Description:

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.

Treatment:

Other: NVIf

INF® Therapy + NVIf Group

Experimental group

Description:

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.

Treatment:

Other: NVIf

Other: INF® Therapy