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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to compare the effectiveness of providing dietary education to complement Intraneural Facilitation® Therapy (INF® Therapy) (a physical therapy technique being evaluated that may help improve circulation) versus INF® Therapy only in adults with a type of neuropathy called distal symmetric polyneuropathy (DSPN).

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 data supports the effectiveness of this treatment for diabetic neuropathy?

Research shows that intraneural facilitation (INF) can improve balance and reduce symptoms in patients with diabetic peripheral neuropathy, suggesting it may be an effective treatment option. ^{1 2 3 4 5}

Is the combination of INF and dietary education safe for humans?

The safety of dietary education, including nutritional counseling for diabetes, is well-documented and generally considered safe for humans. However, there is no specific safety data available for Intraneural Facilitation (INF) therapy in the provided research articles. ^{6 7 8 9 10}

What makes Intraneural Facilitation (INF) treatment unique for diabetic neuropathy?

Intraneural Facilitation (INF) treatment is unique because it focuses on improving blood flow to nerves, which may help alleviate symptoms of diabetic neuropathy. Unlike standard treatments that primarily manage blood sugar levels, INF aims to directly address nerve health and function. ^{7 8 11 12 13}

Research Team

Eric G Johnson, DSc, MS-HPEd

Principal Investigator

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Treating peripheral neuropathy in individuals with type 2 diabetes mellitus with intraneural facilitation: a single blind randomized control trial. [2022]

2. Switzerland 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. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Health state preference assessment in diabetic peripheral neuropathy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of a Novel Therapeutic Intervention in Patients With Diabetic Peripheral Neuropathy. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

[Nutritional therapy in diabetes mellitus]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Medical nutrition therapy in type 2 diabetes. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a psycho-educational nutritional program in diabetic patients. [2022]

11. Spain pubmed.ncbi.nlm.nih.gov

[Medical nutritional therapy and therapeutic patient education in diabetes]. [2011]

12. Austria pubmed.ncbi.nlm.nih.gov

[Experience in dietary counseling of diabetics with a new multifunctional learning aid]. [2006]

13. Pakistan pubmed.ncbi.nlm.nih.gov

Indications for formula medical nutrition therapy in diabetes. [2019]