Circulatory and Dietary Interventions for Peripheral Neuropathy

(CDIN Trial)

Overseen By Kyan Sahba, Post Doctoral Fellow, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Chemotherapy, Radiation, Dialysis, others

Disqualifiers: Alcohol misuse, Renal failure, Hypertension, Dyslipidemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well different treatments can improve symptoms for those with peripheral neuropathy, which often causes pain and numbness in the legs. Participants are divided into three groups: one receives a hands-on therapy called Intraneural Facilitation® (INF®) that aims to boost nerve circulation, another follows a diet plan to eliminate foods that worsen nerve inflammation, and the last group tries both approaches. The goal is to determine which method best improves pain, sensation, and overall quality of life. Individuals with a confirmed diagnosis of moderate to severe neuropathy in their legs, who can walk independently, might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could significantly enhance quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it excludes those using medications that may interfere with the study results. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Intraneural Facilitation® (INF®) therapy is generally well-tolerated. Studies have found that it improves nerve function by increasing blood flow in small blood vessels. While some studies focus on its benefits for pain relief and quality of life, they report no major safety concerns. This suggests that INF® therapy is safe for most people.

For the NVIf dietary intervention, research indicates that dietary changes, such as eliminating certain foods, can reduce inflammation and improve nerve health. These changes are usually low risk, and most people find them easy to follow without major side effects.

Both INF® therapy and NVIf are considered safe treatments, with few adverse effects reported in studies. This makes them promising options for those seeking to improve neuropathy symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for peripheral neuropathy because they offer innovative approaches that differ from conventional options like medications and physical therapy. INF® Therapy is distinctive as it involves a manual technique aimed at enhancing neural circulation through specific manual holds, potentially improving nerve function more directly than typical therapies. Meanwhile, NVIf is unique due to its use of patented ultrasound technology to pinpoint and eliminate foods that trigger inflammation and hinder circulation, potentially offering a personalized dietary approach to nerve health. By targeting circulation and inflammation in novel ways, these treatments could provide more tailored and effective management of peripheral neuropathy symptoms.

What evidence suggests that this trial's treatments could be effective for neuropathy?

Research has shown that Intraneural Facilitation® (INF®) therapy, one of the treatments in this trial, can improve symptoms of nerve damage, known as neuropathy. Studies have found that it boosts blood flow to the nerves, which is crucial for maintaining their health. INF® therapy has proven particularly effective in reducing pain and improving function for individuals with nerve-related issues.

The NVIf dietary plan, another treatment option in this trial, focuses on eliminating foods that cause inflammation and harm nerve health. A review of studies found that dietary changes suggested by NVIf can ease neuropathy symptoms by reducing inflammation. This method addresses the root causes of nerve pain through diet. Overall, both approaches, as studied in this trial, have the potential to manage and improve neuropathy symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

Kyan Sahba, PhD

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for people aged 35-85 with moderate to severe neuropathy due to Type 2 Diabetes. Participants should be experiencing neuropathic pain and peripheral neuropathy.

Inclusion Criteria

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

Exclusion Criteria

Active alcohol or drug misuse

Autoimmune disease

Morbid obesity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either INF® therapy, NVIf intervention, or a combination of both. INF® therapy involves 60-minute sessions, 2-3 times per week, for a total of 8 sessions. NVIf involves food-guided elimination visits and weekly check-ins.

5 weeks

8 sessions (in-person) for INF® therapy, 4 visits (in-person) for NVIf, weekly phone check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, functional limitation, sensory function, quality of life, neurovascular function, and gait speed.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INF® Therapy
• NVIf

Trial Overview The study tests three treatments: INF® therapy alone, INF® combined with NVI food-guided elimination (NVIf), and NVIf alone, to see which improves neuropathy symptoms the most.

How Is the Trial Designed?

Group I: NVIf Only Group Experimental Treatment 1 Intervention

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.

Group II: INF® Therapy Only Group Experimental Treatment 1 Intervention

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.

Group III: INF® Therapy + NVIf Group Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11940592/

A Retrospective Assessment of Neuropathic Pain in ... INF® Therapy has demonstrated improved neural performance in multiple studies, potentially due to targeting and overcoming microvascular ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.12068

A pilot study of intraneural facilitation versus standard ... We conducted a randomized pilot study evaluating the efficacy of INF vs. standard PT in the prevention of CIPN (NCT 03272919).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04025320?term=AREA%5BConditionSearch%5D(%22Neuropathy%22)%20AND%20AREA%5BInterventionSearch%5D(%22iron-dextran%20complex%22)&rank=6

The Effect of Intraneural Facilitation Therapy on Diabetic ... The purpose of this graduate student research study is to explore the effects of a new treatment known as Intraneural facilitation (INF) on Diabetes ...

4. faseb.onlinelibrary.wiley.com faseb.onlinelibrary.wiley.com/doi/abs/10.1096/fasebj.2018.32.1_supplement.853.19

Ultrasound analysis of a novel therapeutic intervention for ... The PI showed significant improvement from pre- to post-treatment in both neuropathy categories, CIN and IDN respectively (p < 0.05). The ...

5. lluh.org lluh.org/services/neuropathic-therapy-center/about-center/research

Research - Neuropathic Therapy Center The success of INF® Treatment demonstrates it's possible to actually manipulate circulation back to the nerve.

6. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(25)00138-2/fulltext

Safety and Efficacy of Magnetic Peripheral Nerve ... Pain relief, sensation, and QoL improvements were shown with high confidence. Pain responder rates ranged from 70.0% to 81.4%, a level ...