A Phase 3 interventional study of Cannabidiol and β-Caryophyllene Patch and Oxygen-Ozone Therapy in Neck Pain, sponsored by Humanitas Clinical and Research Center. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Humanitas Clinical and Research Center · Phase 3, Interventional, and Treatment
Among 18 studies in Neck Pain with a site in Italy — 5 open to participants now, 5 under way, 2 of them phase 3. Neck Pain · Italy.
Among the 18 studies in Neck Pain with a site in Italy, this one is the 11th largest by planned enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2024, is one of 3 in phase 3, and was the 14th registered.
1,361 studies on the registry are indexed under Neck Pain; 300 are open to participants now.
Browse Neck Pain studies →5 of the 18 studies in Neck Pain with a site in Italy are open now. Recruiting first, the newest first:
Aurel Mengri · Sites in Italy
Ages 18–75
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18+
IRCCS San Raffaele · Sites in Italy
Ages 18–70 · Healthy volunteers
Gelscom SAS · Sites in Italy
Ages 18–120
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 155 Neck Pain studies recruiting now, 25 (16%) set no upper age limit and 117 (75%) stop at 75 or younger; 8 take children under 18; 26 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 4 · Phase 4 1
First in 2005; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 52 is close to the median of 50 across 1,117 interventional studies indexed under Neck Pain.
Median enrollment 70 across the 16 interventional studies, 123 across the 2 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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2 of 18 have an industry lead sponsor. The 10 most frequent:
Humanitas Clinical and Research Center is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
Humanitas Clinical and Research Center has 1 study filed under Neck Pain — fewer than ten, so there is no comparison to draw.
1 of the studies in Neck Pain with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07832929Aurel MengriGelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS) | 2026-11-23 |
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Among the 18 studies in Neck Pain with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
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.
Secondary objectives of this study are:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug page: Cannabidiol
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
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
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.
Time frame: 14 days
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 1 week
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 2 weeks
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 4 weeks
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 12 weeks
Numeric Pain Rating Scale
Measure of pain intensity. The scale goes from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 36 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2024; primary completion for Sep 2024, 7 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cannabidiol
Humanitas Clinical and Research Center