Recruiting

Physiologic Approaches for Peripheral Neuropathy Treatment

Study Aim

This study aims to evaluate the effect of INF therapy and standard physical therapy on heart health by measuring heart rate variability in people with peripheral neuropathy.

What is being tested

Intraneural Facilitation Therapy Treatment

+ Standard Physical Therapy Treatment

Other

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 45 to 85 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2024

See protocol details

Summary

Principal SponsorLoma Linda University

Study ContactMark Bussell, DPT, OCS

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 8, 2024

Actual date on which the first participant was enrolled.

This study is investigating two different approaches to treating peripheral neuropathy, a condition that affects the nerves and can cause pain and numbness, especially in the legs and feet. The study focuses on comparing INF® Therapy with standard physical therapy to find out which is more effective in improving heart rate variability (HRV), a measure of the nervous system's health. Participants are individuals who suffer from peripheral neuropathy, and this research could help improve treatment strategies, leading to better quality of life for those affected by this condition. Participants will attend multiple sessions where they undergo various tests and treatments. In the first and eleventh sessions, they will complete different assessments, including pain and neuropathy scales, and have their blood flow and nerve health tested. They will receive either INF® Therapy or standard physical therapy in sessions lasting 60 minutes. Throughout the study, heart rate variability is monitored using the Welltory App, and blood samples are collected to measure specific health markers. This information will help researchers understand the effects of the therapies on the nervous system and overall health.

Official TitleA Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

NCT05577390

Principal SponsorLoma Linda University

Study ContactMark Bussell, DPT, OCS

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 45 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate

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.

Cellphone access with Android 5.0 and up or iOS 14.0 or later.

1 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Loma Linda University Health Neuropathic Therapy Center

Loma Linda, United StatesOpen Loma Linda University Health Neuropathic Therapy Center in Google Maps

Recruiting

One Study Center