Cannabis Vs Opioids Pain Management Objective Testing Comparisons

Not Applicable

Not yet recruiting

• Conditions: Circulatory Disorders; Chronic Pain
• Interventions: Device: Monochromatic Infrared Photo Energy (MIRE); Device: Transcutaneous Electrical Nerve Stimulation; Drug: Opioids; Drug: Cannabis

• Registration Number: NCT03734731
• Lead Sponsor: American Association of Sensory Electrodiagnostic Medicine

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).

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Status Verified: 2023-10
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Study Start: 2025-02-03
• Primary Completion: 2026-01-03
• Study Completion: 2026-01-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Objective Nerve Conduction testing	Opioids	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.
Objective Nerve Conduction testing	Transcutaneous Electrical Nerve Stimulation	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.
Objective Nerve Conduction testing	Monochromatic Infrared Photo Energy (MIRE)	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.
Objective Nerve Conduction testing	Cannabis	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.

Primary Outcome Measures

Name	Time	Method
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