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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Objective Nerve Conduction testing | Other | Therapy of chronic pain and swelling with Monochromatic Infrared Photo Energy (MIRE) in combination with Transcutaneous Electrical Nerve Stimulation (TENS) and Cannabis or Opioids, to determine which treatment is deemed as the most successful, through objective nerve conduction testing with Neural Scan or AXON-II testing systems. Other types of therapies may be introduced during comparison reviews. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monochromatic Infrared Photo Energy (MIRE) | Device | Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronald F Davis | Contact | 501-690-4028 | rondavis2227@gmail.com | |
| Brook Davis | Contact | 501-843-4380 | nctclinicaltrial@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ronald F Davis | AASEM/ADAPT/DTSC | Study Director |
| Brook Davis | ADAPT/DTSC | Study Director |
| James Hedgecock, D.C., PhD |
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Through AASEM publications
Annually reviews / new CME training course provided periodically during every year
Must be an AASEM certified physician/principal investigator or trial personnel. Otherwise may be obtained on AASEM website.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000701 | Analgesics, Opioid |
| C587251 | nabiximols |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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
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| Transcutaneous Electrical Nerve Stimulation | Device | Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve |
|
| Opioids | Drug | Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator |
|
| Cannabis | Drug | 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 |
|
|
| American Association of Sensory Electrodiagnostic Medicine |
| Study Director |
| Chad Pfefer, M.D. | American Association of Sensory Electrodiagnostic Medicine | Study Chair |
| Michael F Boyer, M.D. | American Association of Sensory Electrodiagnostic Medicine | Principal Investigator |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |