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.
