Cannabis Vs Opioids Pain Management Objective Testing Comparisons
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monochromatic Infrared Photo Energy (MIRE), Transcutaneous Electrical Nerve Stimulation, Opioids, Cannabis.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Circulatory Disorders. Basic parameters: up to 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- 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
Primary outcome measures
- Change in pain and swelling, as verified by objective nerve conduction testing [Time frame: 4 to 8 weeks per nerve]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT03734731 · DTSC110118