Cannabis Vs Opioids Pain Management Objective Testing Comparisons (CVO)

American Association of Sensory Electrodiagnostic Medicine (AASEM)

Status: Begins enrollment in 3 months

Conditions: Chronic Pain; Circulatory Disorders

Treatments: Device: Monochromatic Infrared Photo Energy (MIRE); Drug: Cannabis; Device: Transcutaneous Electrical Nerve Stimulation; Drug: Opioids

Study type: Interventional

Funder types: Industry

Identifiers

NCT03734731

DTSC110118

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Objective Nerve Conduction testing

Other group

Description:

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.

Treatment:

Drug: Opioids

Device: Transcutaneous Electrical Nerve Stimulation

Drug: Cannabis

Device: Monochromatic Infrared Photo Energy (MIRE)