Clinical trial NCT05577390: A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
Official title: A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Neuropathy With Type 2 Diabetes
Keywords: Intraneural Facilitation Therapy
Type 2 Diabetes
Neuropathy
Heart rate variability
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms: One INF® Therapy Treatment group and One standard physical therapy treatment group
Primary purpose: TREATMENT

Brief 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.

Detailed description: Study participants will be assessed on the first, second, fifth, tenth and eleventh sessions.

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. The first session will also include completion of the Background Information form. Patients will be asked to wear loose fitting clothing and to arrive 15 minutes early to complete the informed consent documents on the first session.

Welltory App measurements to assess heart rate variability will be taken in the morning and evening the day before, the day of, and the day after each treatment session.

On the second session the patient will have:

* Electrocardiogram testing (ECG) for assessment of heart rate variability (HRV) using PowerLab+LabChart and BioAmp (AD Instruments, Colorado Springs, CO).
* Near-infrared Spectroscopy (NIRS) measurement using a Foresight Elite monitor (Edwards LifeSciences, Irvine, CA)
* Laser Doppler flowmetry (LDF) measurement using a skin surface Laser Doppler add-on for Chart/Powerlab (AD Instruments, Colorado Springs, CO).
* Welltory App measurements will be taken before and after treatment to assess for heart rate variability (HRV).
* A blood draw will be completed by a licensed lab technician to measure blood cytokine and HbA1C levels. A total of 1 1/3 teaspoons of blood will collected at this time point. The blood draw will be performed prior to treatment.
* The patient will then receive a 60 minute INF® Therapy or standard physical therapy session.
* The aforementioned tests will then be repeated including ECG, NIRS, and LDF to measure post treatment values.

During the third, fourth, sixth, seventh, eighth, and ninth sessions, the patient will have a 60 minute INF® Therapy or standard physical therapy session. Welltory App measurements will be taken before and after treatment to assess for heart rate variability (HRV).

On the fifth session the patient will have a 60 minute INF® Therapy or standard physical therapy session. Welltory App measurements will be taken before and after treatment to assess for heart rate variability (HRV). Followed by:

• A blood draw by a licensed lab technician to measure blood cytokine levels. A total of 1 ¼ teaspoons will be collected at this time point.

On the tenth session the patient will have a 60 minute INF® Therapy or standard physical therapy session. Welltory App measurements will be taken before and after treatment to assess for heart rate variability (HRV). Followed by:

* Electrocardiogram testing (ECG) for assessment of heart rate variability (HRV) using PowerLab+LabChart and BioAmp (AD Instruments, Colorado Springs, CO).
* Near-infrared Spectroscopy (NIRS) using a Foresight Elite monitor (Edwards LifeSciences, Irvine, CA)
* Laser Doppler flowmetry (LDF) measurement using a skin surface Laser Doppler add-on for Chart/PowerLab (AD Instruments, Colorado Springs, CO).
* A blood draw will be completed by licensed lab technician to measure blood cytokine levels and HbA1C. A total of 1 1/3 teaspoons will be collected at this time point.

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

Primary outcomes:
measure: The Impact of INF® Therapy and Standard Physical Therapy on Heart Rate Variability
timeFrame: Through study completion, an average of 6 weeks.
Secondary outcomes:
measure: The impact of INF® Therapy and Standard Physical Therapy on neuropathy severity
timeFrame: Through study completion, an average of 6 weeks.
measure: The impact of INF® Therapy and Standard Physical Therapy on blood flow
timeFrame: Through study completion, an average of 6 weeks.
measure: The impact of INF® Therapy and Standard Physical Therapy on inflammation
timeFrame: Through study completion, an average of 6 weeks.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health Neuropathic Therapy Center
state: California
Study officials:
affiliation: Loma Linda University Health
name: Mark Bussell, DPT, OCS
role: PRINCIPAL_INVESTIGATOR
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