Last updated: December 12, 2023
Sponsor: Humanitas Clinical and Research Center
Overall Status: Active - Not Recruiting
Phase
3
Condition
Neck Pain
Chronic Pain
Treatment
Cannabidiol and β-Caryophyllene Patch
Oxygen-Ozone Therapy
Clinical Study ID
NCT06099171
OZLEVOTENS
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Neck pain resulting from spinal pathology present for at least 1 month with or withoutbrachial irradiation
- Cervical radiographic and/or MRI examination certifying the pathology of the spine
- Failure of previous conservative treatment (pharmacological or physiotherapy)
- Adults
- Signing of informed consent
Exclusion
Exclusion Criteria:
- Specific causes of neck pain (trauma, spinal deformity, fracture, neoplasia)
- Central or peripheral neurological signs
- Rheumatic diseases: diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriaticarthritis, gout, ankylosing spondylitis or arthritis secondary to other inflammatorydiseases, chondrocalcinosis, Paget's disease or villonodular synovitis
- Neuromuscular disorders
- Presence of cognitive-behavioral deficit or psychiatric illness which, in the opinionof the investigator, could compromise patient safety or interfere with the evaluationof the effects of the treatment
- Surgery in the previous 6 months
- Cervical infiltrative treatments in the previous 4 months
- Use of orally administered systemic steroids within 2 weeks prior to screening
- Pregnant or breastfeeding women or women planning to become pregnant during the studyparticipation period
- Known alcohol or drug dependence currently or within the past year
Study Design
Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Cannabidiol and β-Caryophyllene Patch
Phase: 3
Study Start date:
February 01, 2024
Estimated Completion Date:
March 01, 2025
Study Description
Connect with a study center
Humanitas Clinical and Research Hospital
Rozzano, Milano 20089
ItalySite Not Available
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