Clinical trial NCT03734731: Cannabis Vs Opioids Pain Management Objective Testing Comparisons
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Circulatory Disorders
Lead sponsor: American Association of Sensory Electrodiagnostic Medicine
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 1000
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain and swelling, as verified by objective nerve conduction testing
timeFrame: 4 to 8 weeks per nerve
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AASEM/ADAPT/DTSC
name: Ronald F Davis
role: STUDY_DIRECTOR
affiliation: ADAPT/DTSC
name: Brook Davis
role: STUDY_DIRECTOR
affiliation: American Association of Sensory Electrodiagnostic Medicine
name: James Hedgecock, D.C., PhD
role: STUDY_DIRECTOR
affiliation: American Association of Sensory Electrodiagnostic Medicine
name: Chad Pfefer, M.D.
role: STUDY_CHAIR
affiliation: American Association of Sensory Electrodiagnostic Medicine
name: Michael F Boyer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: