Cannabis Vs Opioids Pain Management Objective Testing Comparisons

Chronic Pain Clinical Trial

— CVO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03734731
• Other study ID #: DTSC110118
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 3, 2025
• Est. completion date: January 3, 2026

Study information

• Verified date: October 2023
• Source: American Association of Sensory Electrodiagnostic Medicine
• Contact: Ronald F Davis
• Phone: 501-690-4028
• Email: rondavis2227[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: January 3, 2026
• Est. primary completion date: January 3, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Circulatory Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American Association of Sensory Electrodiagnostic Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain and swelling, as verified by objective nerve conduction testing	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