Cannabis Vs Opioids Pain Management Objective Testing Comparisons

Официальное название

Clinical Trial Policy Study for the Objective Comparison of Cannabis Vs Opioids (CVO) Pain Management and Therapy Types for Circulatory and Chronic Pain Issues

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство Monochromatic Infrared Photo Energy (MIRE)
  Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve
• Устройство Transcutaneous Electrical Nerve Stimulation
  Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve
• Препарат Opioids
  Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator
• Препарат 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

Первичные конечные точки

• Change in pain and swelling, as verified by objective nerve conduction testing [Срок оценки: 4 to 8 weeks per nerve]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT03734731 · DTSC110118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗