Combined Circulatory and Dietary Interventions for Neuropathy

Official title

Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

• Change in Pain Intensity [Time frame: Baseline (Week 0) and post-intervention (Week 4-5)]
• Change in Sensory Function [Time frame: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)]
• Change in Functional Limitation [Time frame: Baseline (Week 0) and post-intervention (Week 4-5)]
• Change in Gait Speed [Time frame: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)]
• Change in Mobility and Fall Risk [Time frame: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)]

Secondary outcome measures (1)

• Change in Quality of Life [Time frame: Baseline (Week 0) and post-intervention (Week 4-5)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Neuropathic Therapy Center — Loma Linda

Identifiers

NCT: NCT07213843 · 5250381

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗