Cannabis Vs Opioids Pain Management Objective Testing Comparisons (CVO)

January 10, 2024 updated by: American Association of Sensory Electrodiagnostic Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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

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
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
4 to 8 weeks per nerve

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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
  • Principal Investigator: Michael F Boyer, M.D., American Association of Sensory Electrodiagnostic Medicine
  • Study Chair: Chad Pfefer, M.D., American Association of Sensory Electrodiagnostic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 3, 2025

Primary Completion (Estimated)

January 3, 2026

Study Completion (Estimated)

January 3, 2026

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTSC110118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Through AASEM publications

IPD Sharing Time Frame

Annually reviews / new CME training course provided periodically during every year

IPD Sharing Access Criteria

Must be an AASEM certified physician/principal investigator or trial personnel. Otherwise may be obtained on AASEM website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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