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

NCT06099171 | Unknown Phase 3

• 1 other identifier: OZLEVOTENS
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 neck pain by evaluating the following aspects:

• Reduction of pain
• Reduction of disability associated with neck pain

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

  Measure for reporting neck pain disability. It is a 10-items questionnaire; each question is scored on a 6-point scale ranging from 0 (no disability) to 5 (full disability), and these are added together to make a total score ranging from 0 to 50, which is interpreted as follows: 0 to 4= no disability, 5 to 14= mild disability, 15 to 24= moderate disability, 25 to 34= severe disability, and greater than 34 = complete disability. Evaluators can choose to provide a percentage score as a means of dealing with unanswered questions.

  14 days

Secondary Outcomes (9)

• Numeric Pain Rating Scale

  1 week

• Numeric Pain Rating Scale

  2 weeks

• Numeric Pain Rating Scale

  4 weeks

• Numeric Pain Rating Scale

  12 weeks

• Numeric Pain Rating Scale

  36 weeks

Study Arms (2)

Oxygen-Ozone Therapy plus Cannabidiol and ß-Caryophyllene Patch

EXPERIMENTAL

The patients will undergo 8 session of oxygen-ozone therapy, 2 per week. In each session 10 cc of a gaseous mixture of oxygen-ozone (at a concentration of 10 μg of ozone per ml of oxygen) will be injected with 6 paravertebral injections. For the fisrt 2 weeks of oxygen-ozone therapy patients will be asked to apply patches with local action based on Cannabidiol and ß-Caryophyllene for 8-24 hours/day for 5 days/week.

Drug: Cannabidiol and β-Caryophyllene Patch; Device: Oxygen-Ozone Therapy

Oxygen-Ozone Therapy

ACTIVE COMPARATOR

The patients will undergo 8 session of oxygen-ozone therapy, 2 per week. In each session 10 cc of a gaseous mixture of oxygen-ozone (at a concentration of 10 μg of ozone per ml of oxygen) will be injected with 6 paravertebral injections.

Device: Oxygen-Ozone Therapy

Interventions

Cannabidiol and β-Caryophyllene Patch DRUG

Cannabidiol with its decongestant activity has a soothing action in the area of application, thanks to the association with B-caryophyllene which assists its activity

Also known as: Levotens Patch

Oxygen-Ozone Therapy plus Cannabidiol and ß-Caryophyllene Patch

Oxygen-Ozone Therapy DEVICE

Ozone (O3) is a molecule consisting of 3 atoms of oxygen in a dynamically unstable structure. O3 has the capacity to modulate inflammation. O3 when in contact with human fluids and tissues rapidly reacts, generating many reactive oxygen species, as hydrogen peroxide (H2O2), superoxide ion, and hydroxyl radical (OH-). It is suggested that through moderate oxidative stress generated by these reactive byproducts, O2O3 might produce positive effects in several pathologies, including musculoskeletal affections. Moreover, O2/O3 may directly regulate prostaglandins (PGS) and bradykinin, and suppress several proinflammatory mediators, such as IL-6, IL-8 and TNF-α

Oxygen-Ozone Therapy; Oxygen-Ozone Therapy plus Cannabidiol and ß-Caryophyllene Patch

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Clinical and Research Hospital

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Cristiano Sconza, MD

  Humanitas Clinical and Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiano Sconza, MD

CONTACT

3332781989; cristiano.sconza@humanitas.it

Umberto Massi, MD

CONTACT

3461663927; u.massi@campus.unimib.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: February 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)