CVO: Cannabis Vs Opioids Pain Management Objective Testing Comparisons

Sponsor
American Association of Sensory Electrodiagnostic Medicine (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT03734731
Collaborator
(none)
1,000
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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 InvestigatorIndividual 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)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Jan 3, 2024
Anticipated Study Completion Date :
Jan 3, 2025

Arms and Interventions

ArmIntervention/Treatment
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

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • American Association of Sensory Electrodiagnostic Medicine

    Investigators

    • 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.

    More Information

    Publications

    None provided.
    Responsible Party:
    American Association of Sensory Electrodiagnostic Medicine
    ClinicalTrials.gov Identifier:
    NCT03734731
    Other Study ID Numbers:
    • DTSC110118
    First Posted:
    Nov 8, 2018
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2021