INF + Dietary Education for Diabetic Neuropathy

Overseen By Eric G Johnson, DSc, MS-HPEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Chemotherapy, Dialysis, Amputations, Alcohol misuse, others

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

Compensation: Varies

Number of Visits: 14

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding dietary education to a physical therapy technique called Intraneural Facilitation® Therapy (INF® Therapy) can improve symptoms of diabetic nerve pain. INF® Therapy aims to boost blood flow to nerves, potentially easing discomfort from distal symmetric polyneuropathy, a common type of diabetic nerve damage. The trial includes two groups: one receiving only INF® Therapy and another receiving INF® Therapy with guidance on a gluten-free diet. Ideal participants are adults with type II diabetes who experience moderate to severe nerve pain below the knees and can move independently without assistive devices. As an unphased trial, this study offers a unique opportunity to explore innovative approaches to managing diabetic nerve pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any chronic medical conditions requiring active treatment, you may not be eligible to participate.

What prior data suggests that Intraneural Facilitation® Therapy (INF® Therapy) is safe for treating distal symmetric polyneuropathy (DSPN)?

Research shows that Intraneural Facilitation® Therapy (INF® Therapy) is a hands-on treatment designed to improve blood flow in nerves. However, specific safety information for this therapy is not yet available. Since the trial is in its early stages, safety data for humans remains limited.

Additionally, no specific safety information exists for using INF® Therapy alongside dietary education. The dietary component includes gluten-free meal ideas, which are generally safe for most people. The absence of safety data means tolerance levels for INF® Therapy are unknown. Potential participants should consider this and consult their doctor if they have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for diabetic neuropathy, which often involve medications like pain relievers or antidepressants to manage symptoms, the Intraneural Facilitation® Therapy (INF® Therapy) focuses on improving blood flow directly to the nerves. This manual therapy technique uses a series of specific pressure holds to enhance circulation in and around nerve tissues, potentially offering a more targeted approach to alleviate nerve pain. Additionally, when combined with dietary education that emphasizes a gluten-free diet, this treatment could provide a more holistic approach by addressing potential dietary contributors to nerve inflammation. Researchers are excited because this therapy could offer a non-drug alternative that directly targets the underlying issues in diabetic neuropathy rather than just masking the symptoms.

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

Research shows that Intraneural Facilitation (INF) Therapy, one of the treatments in this trial, may help treat diabetic peripheral neuropathy. Studies have found that INF treatment can reduce pain, improve balance, and enhance protective sensations in patients by increasing blood flow to the nerves, potentially relieving symptoms.

In this trial, some participants will receive INF Therapy combined with dietary education, particularly a gluten-free diet, which might enhance these benefits. Early findings suggest that this combination can further improve pain relief and quality of life. Overall, evidence supports that both INF Therapy alone and with dietary education could effectively manage neuropathy symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Eric G Johnson, DSc, MS-HPEd

Principal Investigator

Department of Physical Therapy School of Allied Health Professions, Loma Linda University

Are You a Good Fit for This Trial?

This trial is for adults aged 50-75 with Type II diabetes and moderate to severe diabetic peripheral neuropathy (DPN), specifically the distal symmetric polyneuropathy (DSPN) type. Participants should be able to perform daily activities without walking aids. Excluded are pregnant individuals, those with certain medical conditions or dietary restrictions, metal allergies, or undergoing specific treatments like chemotherapy.

Inclusion Criteria

I am committed to working on improving my nerve pain symptoms.

I am between 50 and 75 years old.

I do not use any devices to help me walk.

Exclusion Criteria

I am currently experiencing inflammation.

I am currently undergoing chemotherapy, radiation, or dialysis.

I am extremely overweight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Initial Assessment

Participants complete informed consent, VAS pain scale, HIPAA, and medical screening documents. Randomization into groups occurs.

1 week

1 visit (in-person)

Treatment

Participants receive INF® Therapy for ten sessions, two sessions per week. The INF® Therapy+ group also receives dietary education.

5 weeks

10 visits (in-person)

Immediate Post-Intervention Assessment

Participants undergo post-intervention measurements immediately after completing the ten INF® Therapy sessions.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in neuropathy severity, balance stability, pain intensity, and other outcomes three months post-INF® Therapy.

10-14 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Education
• Intraneural Facilitation (INF)

Trial Overview The study aims to assess if adding gluten-free dietary education enhances the benefits of Intraneural Facilitation™ (INF), a physical therapy technique that may improve circulation in people suffering from DSPN due to diabetes.

How Is the Trial Designed?

Group I: Intraneural Facilitation® Therapy (INF® Therapy) + Dietary Education Experimental Treatment 1 Intervention

The INF® Therapy+ group will receive dietary education with weekly follow-up by a physical therapist either in person, or via email or text message. The INF® Therapy+ group will additionally receive meal preparation ideas and sample menus promoting a gluten-free diet.

Group II: Intraneural Facilitation® Therapy (INF® Therapy) Active Control 1 Intervention

INF® Therapy is a manual therapy technique that consists of three components. The first is the pressurization or facilitation hold which biases circulation more consistently in the nerves, which is thought to "pressurize the entire system" The secondary hold attempts to stretch the innervated structure, pulling apart the tough dividing membrane and allowing the pressurized blood flow to transport from the outside "holding" chamber to the endoneurium and push open the closed capillary beds next to the nerve axons. Once capillaries surrounding the nerves are pressurized, the circulation needs to be induced up the neural connective tissue. A separate set of pressure points or "holds" are performed distal to the secondary holds to ensure the circulation is drawn up the inflamed capillary beds using the Bernoulli principle.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

Medical nutrition therapy (MNT) is crucial for effectively managing type 2 diabetes, emphasizing the importance of collaboration between patients and healthcare teams to set achievable dietary goals.

As type 2 diabetes is a lifelong condition, MNT goals should be regularly assessed and adjusted based on the patient's evolving health and circumstances, highlighting the need for ongoing education about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical nutrition therapy in type 2 diabetes. Rezabek, KM.[2017]

A study involving 52 patients with diabetes mellitus revealed that as the severity of diabetic peripheral neuropathy (DPN) increased, patient preferences for health states significantly decreased, indicating a strong correlation between disease severity and quality of life.

Preference scores measured through both rating scale and standard gamble methods showed a consistent decline, with median scores ranging from 0.89 for mild neuropathy to 0.23 for major amputation, highlighting the impact of DPN on patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health state preference assessment in diabetic peripheral neuropathy. Sullivan, SD., Lew, DP., Devine, EB., et al.[2022]

Intraneural facilitation, a novel therapeutic intervention, significantly improved balance measures and neuropathy symptoms in 13 patients with diabetic peripheral neuropathy after 10 treatment sessions.

The intervention led to notable enhancements in the modified Total Neuropathy Scale and the Sensory Organization Test, indicating its potential effectiveness, although some balance components showed no significant change, suggesting areas for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Novel Therapeutic Intervention in Patients With Diabetic Peripheral Neuropathy. Alshahrani, A., Bussell, M., Johnson, E., et al.[2018]

Diabetes-specific nutrition formulas (DSNFs) are designed with slowly-digestible carbohydrates and healthy fats, showing significant improvements in post-meal blood sugar levels and long-term glycemic control in patients with type 2 diabetes (T2D).

Clinical trials indicate that DSNFs not only help manage blood sugar levels but also positively impact various cardiometabolic health outcomes, making them a valuable tool in nutrition therapy for T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? Noronha, JC., Mechanick, JI.[2023]

The article outlines dietary treatment strategies for diabetes, emphasizing nutritional recommendations for prevention and management tailored to different types of diabetes as per the American Diabetes Association guidelines.

It highlights the importance of Therapeutic Education for individuals with diabetes and their families, focusing on educational objectives and strategies to improve adherence to dietary treatments, as recommended by the European Association for the Study of Diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medical nutritional therapy and therapeutic patient education in diabetes]. Jansà, M., Murillo, S., Vidal, M.[2011]

A newly developed multifunctional dietary learning aid significantly improved dietary knowledge regarding carbohydrate and fat quantification in diabetic patients after just one lesson.

The dietary aid is particularly beneficial for elderly patients and those with long-standing diabetes, suggesting its effectiveness across diverse patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience in dietary counseling of diabetics with a new multifunctional learning aid]. Stradner, F., Pristautz, H., Zeichen, R., et al.[2006]

Medical nutrition therapy (MNT) for diabetes can be effectively classified into meal/snack replacements and supplements, addressing various biomedical, psychological, and social needs of patients.

The article emphasizes the importance of aligning MNT with individual lifestyles and pharmacotherapy, promoting a person-centered approach to diabetes care that adapts to the unique requirements of each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for formula medical nutrition therapy in diabetes. Kalra, S., Kalra, B., Sahay, R.[2019]

A 1-week nutritional education program for 83 diabetic patients led to significant long-term changes in dietary habits, with type 1 patients reducing caloric, protein, and fat intake, while type 2 patients showed varied results in carbohydrate and fat consumption.

Two years post-education, 45% of the patients adhered to the European Association Study for Diabetes (EASD) nutritional recommendations, indicating the program's effectiveness in promoting healthier eating behaviors among diabetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a psycho-educational nutritional program in diabetic patients. Schalch, A., Ybarra, J., Adler, D., et al.[2022]

Diabetic Peripheral Neuropathy is a significant health issue, and misunderstandings between healthcare providers and patients about foot ulcer development hinder effective prevention and healing strategies.

Implementing therapeutic educational interventions can help patients better understand their condition and make informed decisions about prevention, which should be repeated periodically for maximum effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The complexity of the diabetic peripheral neuropathy: propositions for therapeutic educational interventions]. Montreuil, C.[2012]

A risk prediction model for diabetic peripheral neuropathy (DPN) was developed using data from 95,604 patients with type 2 diabetes mellitus (T2DM), identifying 11 significant risk factors such as age, smoking, and hemoglobin A1c levels.

The model demonstrated high sensitivity (84.6%) and moderate specificity (66.8%), effectively categorizing patients into risk groups, with very high-risk patients having a 45-fold increased risk of developing DPN compared to low-risk patients, highlighting its potential for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a risk prediction model for early diabetic peripheral neuropathy based on a systematic review and meta-analysis. Liu, X., Chen, D., Fu, H., et al.[2023]

Nutritional therapy for diabetes, applicable to both IDDM and NIDDM patients, emphasizes energy restriction, reduced intake of saturated fats, alcohol, and simple sugars, while increasing fiber consumption to manage blood sugar levels and reduce cardiovascular risks.

Regular screening for microalbuminuria is crucial for diabetic patients, and early signs of nephropathy should prompt protein intake restrictions, highlighting the importance of tailored dietary advice and patient education in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutritional therapy in diabetes mellitus]. Toeller, M.[2015]

Medical nutrition therapy (MNT) is an effective approach for managing glycemia, lipids, and blood pressure in individuals with diabetes, as supported by the 2002 American Diabetes Association guidelines.

MNT should evolve from focusing on weight management to improving insulin resistance and metabolic control, especially as beta-cell function declines, necessitating a shift from dietary management alone to combinations with oral medications and insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based medical nutrition therapy for diabetes. Franz, MJ.[2017]

Intraneural facilitation (INF) treatment significantly improved pain perception and protective sensory function in patients with diabetic peripheral neuropathy (DPN) compared to a sham treatment, indicating its efficacy in managing DPN symptoms.

The study involved 28 patients with type 2 diabetes and moderate-to-severe DPN, who received INF therapy three times a week for three weeks, resulting in notable improvements in balance and sensory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating peripheral neuropathy in individuals with type 2 diabetes mellitus with intraneural facilitation: a single blind randomized control trial. Sahba, K., Berk, L., Bussell, M., et al.[2022]

Citations

1. 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 ...

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

A Retrospective Assessment of Neuropathic Pain in ... This study suggests that blending a mechanical intervention (INF) with a lifestyle modification (NVI-guided food elimination) is effective in improving PQAS ...

3. 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).

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/03000605221109390

Treating peripheral neuropathy in individuals with type 2 ... This current study hypothesized that INF would decrease perceived pain, and improve balance, ambulation, QOL and protective sensory function in patients with ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35922961/

Treating peripheral neuropathy in individuals with type 2 ... INF treatment improved pain perception, the composite static balance score and protective sensations in patients with DPN.

6. withpower.com withpower.com/trial/phase-diabetic-neuropathies-2022-e542a

INF + Dietary Education for Diabetic Neuropathy However, there is no specific safety data available for Intraneural Facilitation (INF) therapy in the provided research articles. Show more. What ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06663670

Intraneural Facilitation Therapy and Nerve Flossing ... Intraneural Facilitation Therapy is a novel manual therapy technique that seeks to enhance endoneurial capillary circulation, bias blood flow ...