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Cannabis Vs Opioids Pain Management Objective Testing Comparisons

NCT ID: NCT03734731

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-03

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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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

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Chronic Pain Circulatory Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Objective Nerve Conduction testing

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.

Group Type OTHER

Monochromatic Infrared Photo Energy (MIRE)

Intervention Type DEVICE

Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve

Opioids

Intervention Type DRUG

Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator

Cannabis

Intervention Type 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

Interventions

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Monochromatic Infrared Photo Energy (MIRE)

Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve

Intervention Type DEVICE

Transcutaneous Electrical Nerve Stimulation

Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve

Intervention Type DEVICE

Opioids

Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Marijuana

Eligibility Criteria

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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.
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Association of Sensory Electrodiagnostic Medicine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald F Davis

Role: STUDY_DIRECTOR

AASEM/ADAPT/DTSC

Brook Davis

Role: STUDY_DIRECTOR

ADAPT/DTSC

James Hedgecock, D.C., PhD

Role: STUDY_DIRECTOR

American Association of Sensory Electrodiagnostic Medicine

Chad Pfefer, M.D.

Role: STUDY_CHAIR

American Association of Sensory Electrodiagnostic Medicine

Michael F Boyer, M.D.

Role: PRINCIPAL_INVESTIGATOR

American Association of Sensory Electrodiagnostic Medicine

Central Contacts

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Ronald F Davis

Role: CONTACT

Phone: 501-690-4028

Email: [email protected]

Brook Davis

Role: CONTACT

Phone: 501-843-4380

Email: [email protected]

Other Identifiers

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DTSC110118

Identifier Type: -

Identifier Source: org_study_id