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A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 11 visits
  • Procedures mentioned: Ultrasound, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects will participate in 11 study visits over a period of 6 weeks."
  • "During the participants first and eleventh sessions participants will complete the Pain Quality Assessment Scale (PQAS), the Lower Extremity Neuropathy Scale (LENS), a vascular analysis of the Neurovascular Index (NVI) using a Philips Affinity 50 Ultrasound, and Neuropad® testing."
  • "Followed by: • A blood draw by a licensed lab technician to measure blood cytokine levels."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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 therapy work, subsequently improving non-invasive treatment methods for T2DPN patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

CA