Chronic Pain, Circulatory Disorders
Conditions
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.
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
DEVICEMonochromatic Infrared Photo Energy (MIRE)
Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve
DEVICETranscutaneous Electrical Nerve Stimulation
Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve
DRUGOpioids
Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator
DRUGCannabis
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
Sponsors
American Association of Sensory Electrodiagnostic Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Individual physician patient studies with all products and services being used on FDA label. Study process being referred to in NCD 310.1 as Clinical Trial Policy (CTP), will be approved by the Principal Investigator
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain and swelling, as verified by objective nerve conduction testing | 4 to 8 weeks per nerve | 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 |
Contacts
Primary ContactRonald F Davis
Backup ContactBrook Davis
Outcome results
None listed