Neck PainPhase 3NCT06099171
Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck Pain
A Phase 3 study testing Cannabidiol and β-Caryophyllene Patch and Oxygen-Ozone Therapy in people with Neck Pain, run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cannabidiol and β-Caryophyllene Patch and Oxygen-Ozone Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to 1 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the 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.
- The primary study endpoint is to establish the improvement in NRS Pain at 14 days from the start of treatment.
- 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.
- Conditions
- Neck Pain
- Being tested
- Cannabidiol and β-Caryophyllene Patch, Oxygen-Ozone Therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol and β-Caryophyllene PatchDrug
Also called Levotens 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
Oxygen-Ozone TherapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Oxygen-Ozone Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (9)
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Measured: 1 week
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Measured: 2 weeks
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Measured: 4 weeks
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Measured: 12 weeks
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Measured: 36 weeks
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.
Measured: 1 week
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.
Measured: 4 weeks
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.
Measured: 12 weeks
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiano Sconza, Humanitas Clinical and Research Center
- Investigators
- Cristiano Sconza, MD, Principal investigator, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099171
- Sponsor's protocol ID
- OZLEVOTENS
- Status last verified
- Dec 2023
- First submitted
- 19 Oct 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06099171
- Acronym / sponsor ID
- OZLEVOTENS
- Conditions
- Neck Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The primary study endpoint is to establish the improvement in NRS Pain at 14 days from the start of treatment.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen-Ozone Therapy plus Cannabidiol and ß-Caryophyllene Patch | Experimental | Drug: Cannabidiol and β-Caryophyllene Patch, Device: Oxygen-Ozone TherapyThe 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. |
| Oxygen-Ozone Therapy | Active comparator | Device: Oxygen-Ozone TherapyThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol and β-Caryophyllene PatchAlso: Levotens PatchCannabidiol with its decongestant activity has a soothing action in the area of application, thanks to the association with B-caryophyllene which assists its activity | Drug | Oxygen-Ozone Therapy plus Cannabidiol and ß-Caryophyllene Patch |
| Oxygen-Ozone TherapyOzone (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 | Device | Oxygen-Ozone Therapy, Oxygen-Ozone Therapy plus Cannabidiol and ß-Caryophyllene Patch |
Primary outcome
Neck Disability Index
Time frame: 14 days
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.
9 secondary outcomes
Numeric Pain Rating Scale
Time frame: 1 week
Numeric Pain Rating Scale
Time frame: 2 weeks
Numeric Pain Rating Scale
Time frame: 4 weeks
Numeric Pain Rating Scale
Time frame: 12 weeks
Numeric Pain Rating Scale
Time frame: 36 weeks
Neck Disability Index
Time frame: 1 week
Neck Disability Index
Time frame: 4 weeks
Neck Disability Index
Time frame: 12 weeks
Neck Disability Index
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristiano Sconza, MD principal investigator
Humanitas Clinical and Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabidiol and β-Caryophyllene Patch and Oxygen-Ozone Therapy in people with Neck Pain, run by Humanitas Clinical and Research Center at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristiano Sconza, MD (3332781989, cristiano.sconza@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.