CVO: Cannabis Vs Opioids Pain Management Objective Testing Comparisons
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.
|Condition or Disease||Intervention/Treatment||Phase|
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).
Arms and Interventions
|Other: Objective Nerve Conduction testing|
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)
Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve
Device: Transcutaneous Electrical Nerve Stimulation
Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve
Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator
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
Primary Outcome Measures
- Change in pain and swelling, as verified by objective nerve conduction testing [4 to 8 weeks per nerve]
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
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.
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.
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- American Association of Sensory Electrodiagnostic Medicine
- Study Director: Ronald F Davis, AASEM/ADAPT/DTSC
- Study Director: Brook Davis, ADAPT/DTSC
- Study Director: James Hedgecock, D.C., PhD, American Association of Sensory Electrodiagnostic Medicine
- Study Chair: Chad Pfefer, M.D., American Association of Sensory Electrodiagnostic Medicine
- Principal Investigator: Michael F Boyer, M.D., American Association of Sensory Electrodiagnostic Medicine
Study Documents (Full-Text)None provided.