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A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
Who can join
Ages 45 to 85 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: 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
About the 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 therapy work, subsequently improving non-invasive treatment methods for T2DPN patients.
What is being tested
- Intraneural Facilitation Therapy Treatment (other)
- Standard Physical Therapy Treatment (other)
Sponsor: Loma Linda University · Participants: 40 · Started: Jan 8, 2024
Contact the study team
- Mark Bussell, DPT, OCS · Phone: 909-558-6799
Official record on ClinicalTrials.gov — NCT05577390
Locations in the U.S.
| California | Loma Linda University Health Neuropathic Therapy Center, Loma Linda |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.