NCT03734731

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: American Association of Sensory Electrodiagnostic Medicine · Industry
• Sex: All
• Age: 90 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Chronic Pain
• Circulatory Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-06-03
• Primary completion: 2027-02-03
• Completion: 2027-02-28
• First posted: 2018-11-08
• Last updated: 2025-12-29