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

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

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

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

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 potential therapeutic interventions are available for the treatment of neck pain, including conservative therapies, minimally invasive procedures and open surgery. In particular, oxygen-ozone percutaneous injections have been tested and have proven to be well tolerated with good clinical results.

Patch cutaneous formulated with cannabidiol and β-carophyllene (Levotens®) has proven to have muscle relaxant and anti-inflammatory effects in an animal models: The tests used allow to evaluate motor performance with reference to motor coordination skills (pole test), exploration (open field test) and resistance to continuous and accelerated movement (rotarod test). These motor skills are impaired in a pain associated inflammatory response condition such as that induced by LPS (lipopolysaccharide). The CBD and BCP-based Levotens® patch placed in the area where the inflammatory stimulus is administered allows the recovery of motor function in the three types of behaviors studied.

Previous data available demonstrate a muscle relaxant action of CBD applied topically through a patch in patients suffering from TMD.

This is a randomized, controlled, prospective evaluation comparing combined treatment with paravertebral oxygen-ozone injections and topical patches containing Cannabidiol and β-Caryophyllene with only OOT. The maximum study duration for each subject will be 6 months. A total of 52 patients will be enrolled. These patients will meet specific inclusion and exclusion criteria but can be generally characterized as patients with neck pain who have been unable to achieve satisfactory pain relief with previous conservative treatments The primary study objective is to determine whether combining Levotens® Patch with OOT could lead to better early pain control than OOT alone.

  1. The primary study endpoint is to establish the improvement in NRS Pain at 14 days from the start of treatment.

  2. Secondary objectives of this study are:

    • Improvement in NRS pain at 1, 2, 4, 12, 36 weeks,

    • Improvement in NDI at 1, 2, 4, 12, 36 weeks.

Connect with a study center

  • Humanitas Clinical and Research Hospital

    Rozzano, Milano 20089
    Italy

    Site Not Available

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