Combined Circulatory and Dietary Interventions for Neuropathy
Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 35 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Ultrasound
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "INF® is a manual therapy, while NVIf utilizes ultrasound guided food elimination."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (1)
CA
- Neuropathic Therapy Center · Loma Linda, CA 92354-0200Mark Bussell, DPT · Study contact · 909-558-6799 · mbussell@llu.eduKyan Z Sahba, PhD · Study contact · 7142350087 · kyansahba@llu.eduKyan Sahba, PhD · Principal investigatorMore trials in Loma Linda