A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Launched by LOMA LINDA UNIVERSITY · Oct 10, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatment options for people who have diabetic peripheral neuropathy, a common condition that affects many individuals with Type 2 diabetes. The trial will compare a non-invasive technique called Intraneural Facilitation Therapy (INF® Therapy) with standard physical therapy to see how each method works to relieve symptoms like pain, numbness, and tingling in the legs and feet. Researchers hope to understand better the ways these treatments help improve balance and reduce pain.

To participate in this study, you need to be between 45 and 85 years old and have moderate to severe diabetic neuropathy symptoms. You’ll need to have your condition confirmed by a doctor and have access to a smartphone. Over six weeks, participants will attend 11 visits, where they will undergo various non-invasive tests to assess pain, blood flow, and other factors related to their condition. This research aims to enhance treatment options for those suffering from diabetic neuropathy, ultimately leading to better management of this condition.

Gender

ALL

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