Cannabis Vs Opioids Pain Management Objective Testing Comparisons

NCT03734731 | Not Yet Recruiting

• 1 other identifier: DTSC110118
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain; Circulatory Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: Monochromatic Infrared Photo Energy (MIRE); Device: Transcutaneous Electrical Nerve Stimulation; Drug: Opioids; Drug: Cannabis

Interventions

Transcutaneous Electrical Nerve Stimulation DEVICE

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

Objective Nerve Conduction testing

Monochromatic Infrared Photo Energy (MIRE) DEVICE

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

Objective Nerve Conduction testing

Opioids DRUG

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

Objective Nerve Conduction testing

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

Also known as: Marijuana

Objective Nerve Conduction testing

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Association of Sensory Electrodiagnostic Medicine: lead

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Analgesics, Opioid; nabiximols

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Ronald F Davis

  AASEM/ADAPT/DTSC

  STUDY DIRECTOR

• Brook Davis

  ADAPT/DTSC

  STUDY DIRECTOR

• James Hedgecock, D.C., PhD

  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

Central Study Contacts

Ronald F Davis

CONTACT

501-690-4028; rondavis2227@gmail.com

Brook Davis

CONTACT

501-843-4380; nctclinicaltrial@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 8, 2018
• Study Start (Estimated): June 3, 2026
• Primary Completion (Estimated): February 3, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Annually reviews / new CME training course provided periodically during every year
• Access Criteria: Must be an AASEM certified physician/principal investigator or trial personnel. Otherwise may be obtained on AASEM website.