Combined Circulatory and Dietary Interventions for Neuropathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-85
SponsorLoma Linda University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
INF® Therapy
Other interventionINF® therapy is a manual technique designed to improve neural circulation by using a series of manual holds administered by a trained practitioner,
NVIf
Other interventionNVIf is a dietary intervention that uses a patented ultrasound technology to assess vascular responses to food allergens
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: INF® Therapy Only GroupExperimental treatment 1 intervention
Group B: NVIf Only GroupExperimental treatment 1 intervention
Group C: INF® Therapy + NVIf GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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)Other outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: