Title

Cannabis Vs Opioids Pain Management Objective Testing Comparisons
Clinical Trial Policy Study for the Objective Comparison of Cannabis Vs Opioids (CVO) Pain Management and Therapy Types for Circulatory and Chronic Pain Issues
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Not yet recruiting
  • Intervention/Treatment

    Cannabis ...
  • Study Participants

    1000
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.
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).
Study Started
Jan 03
2024
Anticipated
Primary Completion
Jan 03
2025
Anticipated
Study Completion
Jan 03
2025
Anticipated
Last Update
Oct 26
2022

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

Drug Opioids

Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator

Drug Cannabis

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

  • Other names: Marijuana

Objective Nerve Conduction testing Other

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.

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.
No Results Posted