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A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

RecruitingNAAges 45 Years - 85 YearsAllLoma Linda University
NCT05577390 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 treat

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📋 Eligibility rules (as published)
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
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What it tests

  • Intraneural Facilitation Therapy Treatment
  • Standard Physical Therapy Treatment
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Where

1 site
Loma Linda University Health Neuropathic Therapy Center
Loma Linda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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