Cannabis Vs Opioids Pain Management Objective Testing Comparisons

Study Overview
=================
Brief Summary
-----------------
Our purpose for the study is to find safer, less intrusive, better preforming non-addictive products, as an alternative therapy for pain relief and to help alleviate the opioid epidemic ongoing in America today.

Detailed Description
-----------------
The AASEM nationally Sponsored/ Physicians Clinical Trial Policy CTP (Medicare study) testing results will be concluded by the Principal Investigators (MDs and DOs) of the study at each site authorized to participate by the AASEM, within the highest of scientific mathematical standards, using Pain DX Neural Scan and/or AXON II testing systems, which include amplitude testing certified with Promethius potentiometers, for Small Pain Fiber (SpF) Nerve Conduction Testing, CMS Carrier CPT codes 95904 now 95909 through 95913 units, as needed. It is expected that, at a later date, other products used for therapy and/or rehabilitation purposes will be added to the comparison protocol for the National Trial Number (NCT# TBA) assigned by the National Library of Medicine (NLM). Other products and/or DME equipment may include: infrared light therapy CPT code 97026, TENS therapy and home units CPT therapy code # 97032, as well as montmorillonite minerals for physical applications (montmorillonite is a natural mineral and has no CPT code - is not a CMS ordinarily payable event).

Official Title
-----------------
Clinical Trial Policy Study for the Objective Comparison of Cannabis Vs Opioids (CVO) Pain Management and Therapy Types for Circulatory and Chronic Pain Issues

Conditions
-----------------
Chronic Pain, Circulatory Disorders

Intervention / Treatment
-----------------
* Device: Monochromatic Infrared Photo Energy (MIRE)
* Device: Transcutaneous Electrical Nerve Stimulation
* Drug: Opioids
* Drug: Cannabis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In the investigator's judgment a high probability of 5 year survival. Patient is able to comply with the study visit schedule. Patient has the ability to comprehend and sign an informed consent document prior to study enrollment. Exclusion Criteria: In the investigator's judgment not a high probability of 5 year survival. Patient is unable to comply with the study visit schedule. Patient does not have the ability to comprehend and sign an informed consent document prior to study enrollment.

Ages Eligible for Study
-----------------
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Individual physician patient studies with all products and services being used on FDA label. Study process being referred to in NCD 310.1 as Clinical Trial Policy (CTP), will be approved by the Principal Investigator
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Objective Nerve Conduction testing<br>Therapy of chronic pain and swelling with Monochromatic Infrared Photo Energy (MIRE) in combination with Transcutaneous Electrical Nerve Stimulation (TENS) and Cannabis or Opioids, to determine which treatment is deemed as the most successful, through objective nerve conduction testing with Neural Scan or AXON-II testing systems. Other types of therapies may be introduced during comparison reviews. | Device: Monochromatic Infrared Photo Energy (MIRE)<br>* Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve<br>Device: Transcutaneous Electrical Nerve Stimulation<br>* Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve<br>Drug: Opioids<br>* Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator<br>Drug: Cannabis<br>* Prescribe Cannabis to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator. Comparing Opioid results to Cannabis results with objective nerve testing<br>* Other names: Marijuana;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain and swelling, as verified by objective nerve conduction testing | To note changes in axon nerve firings obtained by nerve amplitude measurements. Categorize pain and swelling disorders' treatment success or failure, as defined within the AASEM, using the Neural Scan or AXON-II objective nerve conduction testing systems, with objective responses | 4 to 8 weeks per nerve |