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NCT Number: NCT03734731

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.

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Key information

Age range

Up to 90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monochromatic Infrared Photo Energy (MIRE)

Device

Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve

Transcutaneous electrical nerve stimulation

Device

Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve

Opioids

Drug

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

Cannabis

Drug

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

Primary outcomes

  1. Change in pain and swelling, as verified by objective nerve conduction testing

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brook Davis

CONTACT

[email protected]

501-843-4380

Ronald F Davis

CONTACT

[email protected]

501-690-4028

Sponsors and collaborators

Lead sponsor

American Association of Sensory Electrodiagnostic Medicine

Industry

Registry information

Official study 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

Acronym: CVO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2018
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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