Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck Pain

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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 neck pain by evaluating the following aspects:

• Reduction of pain

• Reduction of disability associated with neck pain

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanitas Clinical and Research Center
• Treatments: Cannabidiol; Caryophyllene

Criteria

Inclusion Criteria:

• 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 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, 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