NCT05577390

A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Recruiting now NA Last updated 19 November 2025

What this trial tests

NA trial testing Intraneural Facilitation Therapy Treatment in Peripheral Neuropathy With Type 2 Diabetes in 40 participants. Currently enrolling.

Timeline

8 January 2024

Primary endpoint
1 August 2027

1 August 2027

Quick facts

Lead sponsor	Loma Linda University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	8 January 2024
Primary completion	1 August 2027
Estimated completion	1 August 2027
Sites	1 location across United States

Drugs / interventions tested

• Intraneural Facilitation Therapy Treatment
• Standard Physical Therapy Treatment

Conditions studied

• Peripheral Neuropathy With Type 2 Diabetes — all drugs for Peripheral Neuropathy With Type 2 Diabetes →

Sponsor

Loma Linda University

Who can join

Adults 45 to 85, any sex, with Peripheral Neuropathy With Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetic peripheral neuropathy is one of the most common and costly microvascular complications of diabetes impacting more than 50% of patients and costing more than 10.1 billion dollars annually. Intraneural Facilitation Therapy (INF® Therapy) is a non-invasive technique that has shown to improve balance and pain in patients with Type 2 Diabetic Peripheral Neuropathy (T2DPN); however, the underlying physiological mechanisms need further understanding. The purpose of this study is to investigate the physiological mechanisms behind two approaches to treating T2DPN, INF® Therapy and standard physical therapy. Eligible subjects presenting with diabetic neuropathy symptoms will be recruited and referred to the Loma Linda University Health's Neuropathic Therapy Center. Forty patients will be evenly randomized into two groups: an INF® Therapy Treatment group and standard physical therapy treatment group. Subjects will participate in 11 study visits over a period of 6 weeks. Non-invasive assessments will measure neuropathy pain, heart rate variability, neuropathy severity, blood oxygen levels, and blood flow under the skin. Lab draws will measure inflammation levels in the blood and how well blood sugar levels have been maintained over a period of about 3 months. Descriptive statistics and repeated measures ANOVA will be used to analyze data and answer the research questions. The findings of this study will provide a better understanding of how INF® Therapy and standard physical therapy work, subsequently improving non-invasive treatment methods for T2DPN patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Intraneural Facilitation<sup>TM</sup> Therapy and Exercise on Patients with Type 2 Diabetes: A Single-Blind Randomized Trial.
   Sahba K, Wilson CG, Gonzales E, Hankins J, et al · · 2025 · PMID 41462980 · DOI 10.3390/biomedicines13122968