Chronic PainCVONCT03734731
Cannabis Vs Opioids Pain Management Objective Testing Comparisons
A study testing Monochromatic Infrared Photo Energy (MIRE), Transcutaneous Electrical Nerve Stimulation and Opioids in people with Chronic Pain and Circulatory Disorders, run by American Association of Sensory Electrodiagnostic Medicine.
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. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Chronic Pain, Circulatory Disorders
- What is being tested?
- Monochromatic Infrared Photo Energy (MIRE), Transcutaneous Electrical Nerve Stimulation and Opioids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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).
- Conditions
- Chronic Pain, Circulatory Disorders
- Being tested
- Monochromatic Infrared Photo Energy (MIRE), Transcutaneous Electrical Nerve Stimulation, Opioids, Cannabis
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monochromatic Infrared Photo Energy (MIRE)Device
Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve
Transcutaneous Electrical Nerve StimulationDevice
Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve
OpioidsDrug
Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator
CannabisDrug
Also called Marijuana
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Monochromatic Infrared Photo Energy (MIRE); Device: Transcutaneous Electrical Nerve Stimulation; Drug: Opioids; Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 to 8 weeks per nerve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start3 Jun 2026 (estimated)
- Primary completion3 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Association of Sensory Electrodiagnostic Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald F Davis, Study director, AASEM/ADAPT/DTSCBrook Davis, Study director, ADAPT/DTSCJames Hedgecock, D.C., PhD, Study director, American Association of Sensory Electrodiagnostic MedicineChad Pfefer, M.D., Study chair, American Association of Sensory Electrodiagnostic MedicineMichael F Boyer, M.D., Principal investigator, American Association of Sensory Electrodiagnostic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734731
- Sponsor's protocol ID
- DTSC110118
- Acronym
- CVO
- Status last verified
- Dec 2025
- First submitted
- 23 Oct 2018
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through AASEM publications
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03734731
- Acronym / sponsor ID
- CVO / DTSC110118
- Conditions
- Chronic Pain, Circulatory Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- American Association of Sensory Electrodiagnostic MedicineIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (estimated)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Objective Nerve Conduction testing | Other | Device: Monochromatic Infrared Photo Energy (MIRE), Device: Transcutaneous Electrical Nerve Stimulation, Drug: Opioids, Drug: CannabisTherapy 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. |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monochromatic Infrared Photo Energy (MIRE)Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve | Device | Objective Nerve Conduction testing |
| Transcutaneous Electrical Nerve StimulationApply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve | Device | Objective Nerve Conduction testing |
| OpioidsPrescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator | Drug | Objective Nerve Conduction testing |
| CannabisAlso: MarijuanaPrescribe 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 | Drug | Objective Nerve Conduction testing |
Primary outcome
Change in pain and swelling, as verified by objective nerve conduction testing
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. Through AASEM publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald F Davis study director
AASEM/ADAPT/DTSC
Brook Davis study director
ADAPT/DTSC
James Hedgecock, D.C., PhD study director
American Association of Sensory Electrodiagnostic Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Monochromatic Infrared Photo Energy (MIRE), Transcutaneous Electrical Nerve Stimulation and Opioids in people with Chronic Pain and Circulatory Disorders, run by American Association of Sensory Electrodiagnostic Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronald F Davis (501-690-4028, rondavis2227@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain and swelling, as verified by objective nerve conduction testing (time frame: 4 to 8 weeks per nerve). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.