Status:
UNKNOWN
Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck Pain
Lead Sponsor:
Humanitas Clinical and Research Center
Conditions:
Neck Pain
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The aim of this study is to compare the effectiveness of combined treatment with paravertebral oxygen-ozone injections and topical patches containing Cannabidiol and β-Caryophyllene in patients with n...
Detailed Description
Neck pain is a significant public health burden worldwide, with a prevalence of 2,696.5 per 100,000, and a major cause of disability, responsible for 2.56% of all years lived with disability. Many pot...
Eligibility Criteria
Inclusion
- Neck pain resulting from spinal pathology present for at least 1 month with or without brachial 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
- Specific causes of neck pain (trauma, spinal deformity, fracture, neoplasia)
- Central or peripheral neurological signs
- Rheumatic diseases: diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis secondary to other inflammatory diseases, chondrocalcinosis, Paget's disease or villonodular synovitis
- Neuromuscular disorders
- Presence of cognitive-behavioral deficit or psychiatric illness which, in the opinion of the investigator, could compromise patient safety or interfere with the evaluation of 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 study participation period
- Known alcohol or drug dependence currently or within the past year
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06099171
Start Date
February 1 2024
End Date
March 1 2025
Last Update
December 13 2023
Active Locations (1)
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1
Humanitas Clinical and Research Hospital
Rozzano, Milano, Italy, 20089