Diabete Type 2, Neuropathy, Painful
Conditions
Keywords
neuropathy, diabetes type 2
Brief summary
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
OTHERINF® Therapy
INF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,
OTHERNVIf
NVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study uses an open-label design with no masking; both participants and study personnel will know the assigned treatment group.
Intervention model description
This is a randomized, parallel assignment study with three active treatment arms (INF® therapy only, NVIf only, and INF® + NVIf) to compare their effects on neuropathy symptoms
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sensory Function | Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5) | 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) |
| Change in Gait Speed | Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5) | 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) |
| Change in Mobility and Fall Risk | Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5) | 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. |
| Change in Pain Intensity | Baseline (Week 0) and post-intervention (Week 4-5) | 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. |
| Change in Functional Limitation | Baseline (Week 0) and post-intervention (Week 4-5) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline (Week 0) and post-intervention (Week 4-5) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Neurovascular Function and Inflammation | Baseline (Week 0) and post-intervention (Week 4-5) | 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. |
Countries
United States
Contacts
Primary ContactKyan Sahba, Post Doctoral Fellow, PhD
Backup ContactMark Bussell, Clinical Director, DPT
Outcome results
None listed