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

NCT06099171 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-12-13

No results posted yet for this study

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

Interventions

DRUG

Cannabidiol and β-Caryophyllene Patch

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

DEVICE

Oxygen-Ozone Therapy

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

Sponsors & Collaborators

  • Humanitas Clinical and Research Center

    lead OTHER

Principal Investigators

  • Cristiano Sconza, MD · Humanitas Clinical and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-09-01
Completion
2025-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099171 on ClinicalTrials.gov