Study Inclusion and Exclusion Criteria Based on Israeli Ministry of Health Regulations.
Study Inclusion and Exclusion Criteria Based on Israeli Ministry of Health Regulations.
| Inclusion Criteria | |
|---|---|
| 1. | >18 years of age |
| 2. | Mild to severe LBP and/or sciatica |
| 3. | Imaging studies (CT or MRI) that support symptomatic cause due to anatomical abnormality |
| 4. | Unresponsive to standard therapy at least 1 month |
| 5. | Physically and mentally willing and able to comply with treatment regimen and understand informed consent and study procedures |
| 6. | Signed and dated informed consent form |
| Exclusion Criteria | |
| 1. | Screening VAS pain score <6 (scale: 0=no pain; 10=worst imaginable pain) |
| 2. | Known allergy to cannabis or its components |
| 3. | Pregnancy or plans to become pregnant during the study |
| 4. | Participant is breast-feeding or planning to breast-feed during the study |
| 5. | Participant suffers from mental disorder that precludes administration of study drug |
| 6. | Prisoners and soldiers due to free-will informed consent issues |
| 7. | Inability to sign informed consent form |
| 8. | Unstable angina pectoris, or cardiac insufficiency precluding cannabis administration, or congestive heart failure |
| 9. | Immunosuppressed patients unless cannabis administration was deemed safe by the treating physician |
| 10. | Known Aspergillus infection |
| 11. | Panic attacks or anxiety, unless a psychiatrist authorized cannabis therapy following intake interview |
| 12. | Any mental/psychiatric illness in first-degree relative of a young patient (<30 years old) |
| 13. | Severe COPD as defined according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 3, i.e. FEV-1 between 30% and 49%15 |
| 14. | Taking any of the following medications and/or natural remedies: primidone, phenobarbital, carbamazepine, rifampicin, rifabutin, troglitazone, and Hypericum perforatum |