Intraneural Facilitation vs Physical Therapy for Diabetic Neuropathy

(INF Trial)

Overseen By Mark Bussell, DPT, OCS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Beta blockers

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

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

Compensation: Varies

Number of Visits: 11

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how two different treatments help people with Type 2 Diabetic Peripheral Neuropathy (T2DPN), which causes numbness, tingling, or pain in the hands and feet. Participants will receive either Intraneural Facilitation Treatment™, a non-invasive method to reduce pain and improve balance, or standard physical therapy. The researchers aim to understand how these treatments affect blood flow and pain levels, ultimately improving care for T2DPN. People with moderate to severe symptoms, such as burning or sharp pain from T2DPN, who can use a smartphone, might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for T2DPN.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking beta blockers.

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

Research suggests that Intraneural Facilitation (INF) Therapy could safely treat diabetic nerve damage. Studies have shown that INF Therapy may improve nerve function and reduce symptoms like pain and numbness. Although specific safety details are not provided, INF Therapy is non-invasive, generally making it less likely to cause serious side effects.

The trial does not specify its phase, making it difficult to reference safety evidence from earlier phases. However, testing INF Therapy indicates that previous studies have found it to be fairly well-tolerated. Prospective participants should discuss any concerns with their doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for diabetic neuropathy, like medications and standard physical therapy, focus on managing symptoms rather than addressing the underlying issues. Intraneural Facilitation Therapy (INF®) is unique because it targets the blood vessels that supply nerves, aiming to restore normal nerve function and alleviate symptoms such as pain and numbness. Researchers are excited about INF® Therapy because it's a non-invasive approach that could offer more direct relief by improving nerve health, potentially leading to better long-term outcomes for patients with diabetic neuropathy.

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

Research has shown that Intraneural Facilitation (INF) Therapy, a treatment under study in this trial, can help treat diabetic peripheral neuropathy (DPN). Studies have found that this therapy reduces pain and improves balance in people with DPN. It also restores protective sensations, often lost in those with this condition. INF Therapy appears to work by improving the function of tiny blood vessels, which boosts nerve performance. Several studies have shown promise for this method, suggesting it may be a helpful non-invasive treatment for managing DPN symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Mark Bussell, DPT, OCS

Principal Investigator

Loma Linda University Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Diagnosis confirmed by a physician.

I am between 45 and 85 years old.

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

Exclusion Criteria

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

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 or standard physical therapy over 11 sessions

6 weeks

11 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intraneural Facilitation Treatment™
• Sham Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard Physical Therapy Treatment Group Experimental Treatment 1 Intervention

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

Group II: Intraneural Facilitation Therapy Treatment Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

A systematic review identified that lower extremity strengthening exercises are effective in improving balance dysfunction in patients with Diabetic Peripheral Neuropathy (DPN), based on a thorough analysis of 6 relevant studies.

Other interventions, such as monochromatic infrared energy therapy, vibrating insoles, and cane use, did not have enough evidence to support their effectiveness in improving balance for individuals with DPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance interventions for diabetic peripheral neuropathy: a systematic review. Ites, KI., Anderson, EJ., Cahill, ML., et al.[2018]

Diabetic sensorimotor polyneuropathy (DSP) is the most common type of diabetic neuropathy, and while there is no disease-modifying treatment, optimal glycemic control and lifestyle changes are essential for management.

For painful DSP, effective treatments include medications like pregabalin, amitriptyline, and duloxetine, as well as therapies like transcutaneous electrical nerve stimulation, allowing for tailored treatment based on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatments for diabetic neuropathy. Bril, V.[2022]

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]

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]

In a study of 60 adults with type 2 diabetes and painful diabetic polyneuropathy, combined physical procedures significantly improved nerve function, including terminal latency and action potential amplitude.

Alpha lipoic acid treatment also showed benefits, particularly in conduction velocity and terminal latency, indicating that both interventions can effectively enhance nerve function in diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of the effects combined physical procedures and alpha-lipoic acid on the electroneurographic parameters of patients with distal sensorimotor diabetic polyneuropathy. Grbovic, V., Jurisic-Skevin, A., Djukic, S., et al.[2020]

Diabetic sensorimotor polyneuropathy (DSPN) affects about one-third of people with diabetes, leading to significant health issues like neuropathic pain and foot ulcers, yet it remains underdiagnosed and undertreated.

Management of DSPN should focus on three key areas: lifestyle changes and optimal diabetes control, targeted pharmacotherapy (like α-lipoic acid), and effective pain management strategies, including both medications and non-drug therapies to enhance quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. Ziegler, D., Tesfaye, S., Spallone, V., et al.[2022]

The study involved 10 adults with diabetic peripheral neuropathy (DPN) who participated in a 4-week intervention aimed at promoting physical activity self-management, which included exercise tasters and behavior change counseling.

Participants experienced significant reductions in foot symptoms, specifically aching and burning pain, after the intervention, with no major adverse events reported, indicating that the Physical Activity Intelligence (PAI) self-monitoring approach is both safe and potentially effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal Activity Intelligence eHealth intervention in people with diabetic peripheral neuropathy: A feasibility study. Coombes, BK., Bisset, LM., Sierra-Silvestre, E., et al.[2023]

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]

Citations

1. 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.

2. 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 ...

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

A pilot study of intraneural facilitation versus standard ... A pilot study of intraneural facilitation versus standard physical therapy for prevention of chemotherapy-induced peripheral neuropathy.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06663670

Intraneural Facilitation Therapy and Nerve Flossing ... Intraneural Facilitation and Nerve Flossing Techniques address diabetic peripheral neuropathy, and their effectiveness in improving pain, balance ...

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. ... Facilitation (INF) treatment ...

7. lluh.org lluh.org/sites/lluh.org/files/2021-04/articles-dipn-acrm.pdf

Effects of a Novel Therapeutic Intervention in Patients With ... Conclusions: Intraneural facilitation improved objective balance measures and neuropathy symptoms in patients with diabetic peripheral neuropathy. Further ...