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NCT03734731 | NOT YET RECRUITING | Chronic Pain

Cannabis Vs Opioids Pain Management Objective Testing Comparisons
Sponsor:

American Association of Sensory Electrodiagnostic Medicine

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 disease

Chronic Pain

Circulatory Disorders

Intervention/treatment

Monochromatic Infrared Photo Energy (MIRE)

Transcutaneous Electrical Nerve Stimulation

Opioids

Cannabis

Phase

NA

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
Estimated Enrollment : 1000 participants
Masking : NONE
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
Actual Study Start Date : 2025-02-03
Estimated Primary Completion Date : 2026-01-03
Estimated Study Completion Date : 2026-01-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Cannabis Vs Opioids Pain Management Objective Testing Comparisons

Location Details

NCT03734731

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

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