Intraneural Facilitation vs Physical Therapy for Diabetic Neuropathy

(INF Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Mark Bussell, DPT, OCS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Loma Linda University

Must not be taking: Beta blockers

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Intraneural Facilitation Treatment™ for diabetic neuropathy?

Research indicates that intraneural facilitation may improve balance and neuropathy symptoms in patients with diabetic peripheral neuropathy, suggesting potential benefits for managing this condition. ^{1 2 3 4 5}

How does Intraneural Facilitation Treatment differ from other treatments for diabetic neuropathy?

Intraneural Facilitation 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 pain or control blood sugar, this therapy aims to address the underlying nerve dysfunction. ^{1 4 6 7 8}

Research Team

Mark Bussell, DPT, OCS

Principal Investigator

Loma Linda University Health

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Intraneural Facilitation Treatment™ (Behavioural Intervention)
• Sham Treatment (Behavioural Intervention)

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.

Participant Groups

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+

Adrian Cotton

Loma Linda University

Chief Medical Officer since 2020

MD

Richard H. Hart

Loma Linda University

Chief Executive Officer since 2015

MD, DrPH

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]

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 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]

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]

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]

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]

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]

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]

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. Australia pubmed.ncbi.nlm.nih.gov

Personal Activity Intelligence eHealth intervention in people with diabetic peripheral neuropathy: A feasibility study. [2023]

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

Balance interventions for diabetic peripheral neuropathy: a systematic review. [2018]

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

Development and validation of a risk prediction model for early diabetic peripheral neuropathy based on a systematic review and meta-analysis. [2023]

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

Treatments for diabetic neuropathy. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. [2022]

8. Japan 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. [2020]