Low Back Pain, Sciatica
Conditions
Brief summary
The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.
Detailed description
A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients with Low Back Pain and Sciatica. The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.
Interventions
DRUGBOL-DP-o-04 + SCO
sublingual drops
DRUGPlacebo + SCO
sublingual drops
Sponsors
Breath of Life International Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years of age 2. Mild to Severe Low Back Pain and/or Sciatica 3. Imaging studies (CT or MRI) supporting anatomical abnormality that could be the cause of the symptoms 4. Must be physically and mentally willing and able to comply with the treatment regimen and understand the informed consent and study procedures 5. Signed and dated Informed Consent Form (ICF) 6. Non-responsive to standard therapy for at least 1 month
Exclusion criteria
1. VAS Pain Subscale score at Screening is less than 6 (with 0 being no pain and 10 being worse imaginable pain) 2. Known allergy to cannabis or its components 3. A patient who is pregnant or intends to become pregnant during the study 4. A patient who is nursing or intends to nurse during the study 5. A patient suffering from a mental disorder precluding administration of study drug 6. Prisoners 7. A Patient is unable to sign an informed consent form 8. Unstable angina pectoris 9. Cardiac insufficiency precluding cannabis administration 10. Immunosuppressed patients unless BOL-DP-o-04 administration is deemed safe by the treating physician 11. Known Aspergillus infection 12. Panic attacks or anxiety unless a psychiatrist allowed BOL-DP-o-04 following intake interview 13. Any mental/psychiatric illness in first-degree relative in a young patient \< 30-year-old. 14. Patient with congestive heart failure 15. Subjects who get the following medications: opiates, Primidone, Phenobarbitol, arbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | Baseline to Day 114 | Change in the Oswestry Disability Index. The questionnaire is composed by 10 sections Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Index | Baseline to Day 100 | Change in the Brief Pain Index relative to baseline. The Brief Pain Inventory rapidly assesses the severity of pain and its impact on functioning |
| Short Form (SF12) Mental | Screening to Day 100 | Change in Short Form (SF12) Mental Composite Score.The SF-12 consists of a subset of 12 items that measure eight health domains to assess physical and mental health |
| Pittsburgh Sleep Quality Index | Screening to Day 100 | Change in Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score |
| Opiate consumption and analgesic medication consumption | Screening to Day 100 | Change in Opiate consumption and analgesic medication consumption |
| Patient Global Impression | Baseline to Day 100 | Change in Patient global impression. The Patient Global Impression is a 7 point scale depicting a patient's rating of overall improvement |
Countries
Israel
Outcome results
None listed