A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorLoma Linda University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Chemotherapy
Radiation
Lower extremity amputations
Open wounds
Trial design
Design model
Parallel
Treatments tested in this trial
Intraneural Facilitation Therapy Treatment
Other interventionIntraneural Facilitation Therapy uses three manual holds to bias blood flow to closed endoneurial capillaries. The first is the facilitation hold, which is thought to pressurize the nervous system and bias circulation from the artery into the epineurium. This hold stretches the nerve further than the artery, increasing the amount of elastin in the artery and enlarging the opening of the arterial junction increasing blood into the epineurium. The secondary hold then increases epineurial blood into the transperineurial vessels increasing pressure into the endoneurial capillaries of the site being treated. The third hold, known as the sub hold, encourages blood flow through ischemic endoneurial capillaries that have increased resistance/pressure through the application of Bernoulli's principle. The series of stretches will be repeated on the affected side for the treatment duration.
Standard Physical Therapy Treatment
Other interventionThe standard physical therapy treatment includes muscle stretching, balance, and strengthening exercises known to improve neuropathy symptoms.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intraneural Facilitation Therapy Treatment GroupExperimental treatment 1 intervention
Group B: Standard Physical Therapy Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Impact of INF® Therapy and Standard Physical Therapy on Heart Rate Variability
This is a composite measurement combining electrocardiogram and Welltory App measurements. Heart rate variability (HRV) is the variation in the time interval between consecutive heartbeats and can be used to assess the current state of the nervous system. HRV measures will include LF, HF, LF/HF ratio, SDNN, SDANN, RMSSD, and NN50. The calculation of these variables allows HRV to be quantified. A normal result is between 25 to 50 milliseconds while an abnormal result is less than or greater than that range.
Time frame
Through study completion, an average of 6 weeks.Secondary outcomes
1
The impact of INF® Therapy and Standard Physical Therapy on neuropathy severity
This will be measured by using ultrasound testing with Neurovascular Index assessment. This is a composite measure of blood flow in the limb. Anterograde and retrograde pulsatility index and volume flow measures are combined to form a mathematical descriptor of the waveform followed by a statistical analysis of variation and then a general score is obtained. A normal result is scored at 250 or less.
Time frame
Through study completion, an average of 6 weeks.2
The impact of INF® Therapy and Standard Physical Therapy on blood flow
This will be measured by laser doppler flow. Laser Doppler Flowmetry (LDF) is a non-invasive method for measuring changes in microvascular blood perfusion (blood flow) in a variety of tissues. The frequency distribution of the backscattered light is then calculated based on the illumination of the tissue sample. A normal result is relative to the non-affected limb and will be quantified in each patient and compared between visit 2 and 10. An abnormal result would be a 20% or greater reduction in flow in the affected limb.
Time frame
Through study completion, an average of 6 weeks.3
The impact of INF® Therapy and Standard Physical Therapy on inflammation
This will be measured through cytokine levels taken by lab collection. Cytokine levels can vary widely and depend upon current inflammatory state in the patient. C-reactive protein (CRP) is an inflammatory protein that increases with inflammation or infection and can be used as a clinical marker for inflammation. A normal result is \< 3mg/L for c-reactive protein. Abnormal result would be levels greater than normal for c-reactive protein.
Time frame
Through study completion, an average of 6 weeks.Sponsors and contacts
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Source ClinicalTrials.gov