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Study identifier: NCT05577390 Synced from ClinicalTrials.gov · July 29, 2026
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A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Condition: Peripheral Neuropathy With Type 2 Diabetes  ·  Sponsor: Loma Linda University

PhaseNA
Planned participants40
Who can joinAll sexes, 45 Years to 85 Years
Healthy volunteersNo

About this study

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 the…

This description comes directly from the study's public registry record.

Talk to the study team

Mark Bussell, DPT, OCS  ·  909-558-6799  ·  ntcresearch@llu.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Loma Linda University Health Neuropathic Therapy CenterLoma Linda, California, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05577390