Clinical trial NCT06099171: Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck Pain
Official title: Effectiveness of a Combined Therapy With Paravertebral Oxygen-ozone Injections and Topical Patch Containing Cannabidiol and β-Caryophyllene for Treatment of Neck Pain: a Prospective, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Neck Pain
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Eligibility 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

Primary outcomes:
measure: Neck Disability Index
timeFrame: 14 days
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 1 week
measure: Numeric Pain Rating Scale
timeFrame: 2 weeks
measure: Numeric Pain Rating Scale
timeFrame: 4 weeks
measure: Numeric Pain Rating Scale
timeFrame: 12 weeks
measure: Numeric Pain Rating Scale
timeFrame: 36 weeks
measure: Neck Disability Index
timeFrame: 1 week
measure: Neck Disability Index
timeFrame: 4 weeks
measure: Neck Disability Index
timeFrame: 12 weeks
measure: Neck Disability Index
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Clinical and Research Hospital
state: Milano
Study officials:
affiliation: Humanitas Clinical and Research Center
name: Cristiano Sconza, MD
role: PRINCIPAL_INVESTIGATOR
References: