What side effects are associated with this type of intervention?

Non-invasive treatments for diabetic neuropathy, such as Intraneural Facilitation Therapy (INF® Therapy) and standard physical therapy, generally have minimal side effects, primarily limited to temporary discomfort or soreness at the treatment site. Pharmacological treatments like duloxetine and gabapentin, while effective for pain management, can have side effects including dizziness, drowsiness, dry mouth, and gastrointestinal issues. Duloxetine may also cause increased sweating and potential liver enzyme changes, while gabapentin can lead to weight gain and peripheral edema.

What prior FDA approvals exist?

FDA-approved treatments for diabetic neuropathy primarily include pharmacologic agents such as duloxetine, pregabalin, and venlafaxine, which are used to manage pain associated with the condition. Duloxetine and pregabalin are specifically approved for diabetic peripheral neuropathy. These treatments focus on alleviating neuropathic pain rather than directly improving balance. Non-pharmacologic, non-invasive techniques like Intraneural Facilitation Therapy (INF® Therapy) are still under investigation and have not yet received FDA approval.

What other types of research exist?

Promising, novel alternatives to Intraneural Facilitation Therapy for Diabetic Neuropathy patients in 2024 include: 1) Scrambler Therapy, which uses electrical stimulation to reduce neuropathic pain, 2) Mind-body practices such as mindfulness-based stress reduction (MBSR) and meditation, which have shown potential in managing chronic pain, and 3) Complementary therapies like acupuncture and yoga, which can improve pain and overall quality of life. These alternatives are non-invasive and have demonstrated benefits in clinical settings.

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Intraneural Facilitation vs Physical Therapy for Diabetic Neuropathy (INF Trial)

N/A

Recruiting

Led By Mark Bussell, DPT, OCS

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 45 and 85

Moderate to severe type II diabetic neuropathy with one or more symptoms including: numbness, tingling, burning, sharp pain, and/or increased sensitivity. Diagnosis confirmed by a physician.

Must not have

Subjects with a medical condition predisposing them to medical decline during the next 6 months will be excluded from the study. Examples include: Chemotherapy, Radiation, Lower extremity amputations, Open wounds, Documented active drug and or alcohol misuse, Chronic liver disease, Active inflammations, Other types of neuropathies not associated with diabetes including B12 deficiency and Charcot Marie Tooth, Morbid obesity, Pregnancy, Taking beta blockers, Unable to maintain steady fingers or operate a cellphone, Smoking or ingesting marijuana, Having a pacemaker, Allergies to cobalt, chrome, or nickel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new non-invasive treatment called Intraneural Facilitation Therapy (INF® Therapy) for people with Type 2 Diabetic Peripheral Neuropathy. The goal is to see if this therapy can help reduce pain and improve balance by improving nerve function and blood flow. The study will compare INF® Therapy to standard physical therapy to understand how each treatment works. Intraneural Facilitation (INF) has been previously studied for its potential benefits in treating diabetic peripheral neuropathy, showing promise in improving balance and reducing neuropathy symptoms.

Who is the study for?

This trial is for people aged 45-85 with moderate to severe type II diabetic neuropathy, experiencing symptoms like numbness and pain. Participants must have a physician's diagnosis and access to a smartphone. Excluded are those with conditions that could worsen in 6 months, such as chemotherapy patients or those with recent amputations.

What is being tested?

The study compares Intraneural Facilitation™ (INF), a new non-invasive treatment, against standard physical therapy for diabetic neuropathy. Forty patients will be split into two groups to assess improvements in balance, pain, heart rate variability, blood oxygen levels, and inflammation over six weeks.

What are the potential side effects?

While the trial interventions primarily involve physical therapy techniques which typically have minimal side effects compared to drug treatments, potential side effects may include discomfort at the site of treatment or increased soreness following therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 45 and 85 years old.

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I have type II diabetes with severe nerve pain or numbness.

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I have diabetes and feel numbness, tingling, or sharp pain in my feet or hands.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health issues that could worsen significantly in the next 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Impact of INF® Therapy and Standard Physical Therapy on Heart Rate Variability

Secondary study objectives

The impact of INF® Therapy and Standard Physical Therapy on blood flow

The impact of INF® Therapy and Standard Physical Therapy on inflammation

The impact of INF® Therapy and Standard Physical Therapy on neuropathy severity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard Physical Therapy Treatment GroupExperimental Treatment1 Intervention

Subjects will receive nine 60-minute standard physical therapy treatments during sessions 2 through 10.

Group II: Intraneural Facilitation Therapy Treatment GroupExperimental Treatment1 Intervention

Subjects will receive nine 60-minute INF® Therapy Treatments during sessions 2 through 10. INF® Therapy is a non-invasive treatment that helps eliminate pain, tingling, numbness, and other symptoms that come with neuropathy.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetic Neuropathy, such as Intraneural Facilitation Therapy (INF® Therapy) and standard physical therapy, work by enhancing blood flow and oxygen delivery to the nerves, reducing inflammation, and promoting nerve repair. INF® Therapy specifically aims to improve balance and reduce pain by non-invasively targeting the physiological aspects of nerve function. Standard physical therapy includes exercises to improve strength, flexibility, and balance, which can help mitigate symptoms and improve overall function. These non-invasive treatments are important for patients as they offer symptom relief and improve quality of life without the side effects associated with medications.