A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Loma Linda University Health Neuropathic Therapy Center
RECRUITING
Loma Linda
Contact Information
Primary
Mark Bussell, DPT, OCS
ntcresearch@llu.edu
909-558-6799
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2025-08
Participants
Target number of participants: 40
Treatments
Experimental: Intraneural Facilitation Therapy Treatment Group
Subjects will receive nine 60-minute INF® Therapy Treatments during sessions 2 through 10. INF® Therapy is a non-invasive treatment that helps eliminate pain, tingling, numbness, and other symptoms that come with neuropathy.
Experimental: Standard Physical Therapy Treatment Group
Subjects will receive nine 60-minute standard physical therapy treatments during sessions 2 through 10.
Sponsors
Leads: Loma Linda University

This content was sourced from clinicaltrials.gov