RECRUITING

A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Quick Facts

Study Start:2024-01-08
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05577390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 45 and 85
  2. * Moderate to severe type II diabetic neuropathy with one or more symptoms including: numbness, tingling, burning, sharp pain, and/or increased sensitivity.
  3. * Diagnosis confirmed by a physician.
  4. * Cellphone access with Android 5.0 and up or iOS 14.0 or later.
  1. * Chemotherapy
  2. * Radiation
  3. * Lower extremity amputations
  4. * Open wounds
  5. * Documented active drug and or alcohol misuse
  6. * Chronic liver disease
  7. * Active inflammations
  8. * Other types of neuropathies not associated with diabetes including B12 deficiency and Charcot Marie Tooth
  9. * Morbid obesity
  10. * Pregnancy.
  11. * Taking beta blockers
  12. * Unable to maintain steady fingers or operate a cellphone
  13. * Smoking or ingesting marijuana
  14. * Having a pacemaker
  15. * Allergies to cobalt, chrome, or nickel

Contacts and Locations

Study Contact

Mark Bussell, DPT, OCS
CONTACT
909-558-6799
ntcresearch@llu.edu

Principal Investigator

Mark Bussell, DPT, OCS
PRINCIPAL_INVESTIGATOR
Loma Linda University Health

Study Locations (Sites)

Loma Linda University Health Neuropathic Therapy Center
Loma Linda, California, 92350
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Mark Bussell, DPT, OCS, PRINCIPAL_INVESTIGATOR, Loma Linda University Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08
Study Completion Date2024-12

Study Record Updates

Study Start Date2024-01-08
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Intraneural Facilitation Therapy
  • Type 2 Diabetes
  • Neuropathy
  • Heart rate variability

Additional Relevant MeSH Terms

  • Peripheral Neuropathy With Type 2 Diabetes