Cervical Pain, PosteriorPhase 1/2NCT07504432
Efficacy of Oxygen-ozone Therapy and Cervical Rehabilitation
A Phase 1/2 study testing Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program and Combined O₂O₃ Injection and back school Rehabilitation Program in people with Cervical Pain, Posterior, run by University of Catanzaro at 1 site in Italy.
Trial summary
Neck pain represents one of the most prevalent and disabling musculoskeletal conditions worldwide, significantly affecting functional capacity, work productivity, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Pain, Posterior
- What is being tested?
- Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program and Combined O₂O₃ Injection and back school Rehabilitation Program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 30 Nov 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Diagnosis of neck pain lasting at least 12 weeks
- Moderate to severe pain (score ≥ 4 on a 0-10 pain scale)
- Presence of muscle pain (trigger points) in the neck region
- Willingness to stop pain medications or other treatments that could interfere with the study
- Ability to understand the study and provide informed consent
Who cannot join
- Cognitive impairment or inability to provide informed consent
- Current use of anti-inflammatory drugs, opioids, or ongoing rehabilitation treatments
- Neck pain caused by nerve damage, infections, tumors, or systemic diseases
- History of recent neck trauma or surgery
- Presence of serious medical conditions such as cancer, rheumatoid arthritis, fibromyalgia, thyroid disorders, or diabetes
- Active infections
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Oxygen-ozone Therapy and Cervical Rehabilitation on Functioning in Patients Affected by Nec
Neck pain represents one of the most prevalent and disabling musculoskeletal conditions worldwide, significantly affecting functional capacity, work productivity, and quality of life. Despite the availability of multiple conservative treatment strategies, there is still no clear consensus on the most effective rehabilitation approach, particularly when combining interventional and exercise-based therapies. In recent years, oxygen-ozone (O₂O₃) therapy has emerged as a promising minimally invasive treatment for musculoskeletal pain, due to its potential anti-inflammatory, analgesic, and microcirculatory effects. However, evidence regarding its integration with structured rehabilitation programs for neck pain remains limited.
The purpose of this prospective double-arm study was to evaluate the effectiveness of a combined therapeutic approach based on O₂O₃ paravertebral injections followed by cervical rehabilitation exercises. Specifically, the study aimed to compare two commonly used rehabilitation strategies-McKenzie-based therapy and Back School exercises-in order to determine which approach provides greater benefits when associated with O₂O₃ treatment.
Read more
The primary research question addressed whether the combination of O₂O₃ injections with McKenzie exercises leads to superior improvements in disability, compared to O₂O₃ combined with Back School. Secondary questions explored whether this combined approach is effective in reducing pain intensity and improving health-related quality of life in patients with chronic neck pain.
To answer these questions, patients with clinically significant neck pain were treated with a standardized O₂O₃ injection protocol and subsequently allocated to one of the two rehabilitation programs. Outcomes related to disability, pain, and quality of life were assessed across multiple time points to evaluate both short-term and follow-up effects.
Overall, this study seeks to clarify the added value of integrating interventional therapies with specific rehabilitation strategies and to identify the most effective combination for optimizing functional recovery in patients with neck pain.
- Conditions
- Cervical Pain, Posterior
- Being tested
- Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program, Combined O₂O₃ Injection and back school Rehabilitation Program
- Keywords
- ozone therapy, cervical pain, physiotherapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined O₂O₃ Injection and McKenzie-Based Rehabilitation ProgramDrug
Intramuscular paravertebral oxygen-ozone (O₂O₃) therapy was administered using a gas mixture at a concentration of 10 μg/mL, with a total volume of 10 mL per session. The treatment was delivered through five bilateral paravertebral cervical injections (2 mL per site) using a 27-gauge needle. Sessions were performed once weekly for 8 consecutive weeks.
Following the injection phase, participants underwent a structured rehabilitation program based on the McKenzie method, consisting of 10 supervised sessions over a 2-week period, focused on repeated cervical movements, postural correction, and patient-directed exercises.
Combined O₂O₃ Injection and back school Rehabilitation ProgramDrug
Intramuscular paravertebral oxygen-ozone (O₂O₃) therapy was administered using a gas mixture at a concentration of 10 μg/mL, with a total volume of 10 mL per session. The treatment was delivered through five bilateral paravertebral cervical injections (2 mL per site) using a 27-gauge needle. Sessions were performed once weekly for 8 consecutive weeks.
Following the injection phase, participants underwent a structured rehabilitation program based on the back school, consisting of 10 supervised sessions over a 2-week period, focused on repeated cervical movements, postural correction, and patient-directed exercises.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Intramuscular paravertebral O₂O₃ therapy was administered by a physician specialized in Physical and Rehabilitation Medicine with expertise in ozone injections. All participants received 8 weekly cervical paravertebral injections of an O₂O₃ gas mixture (10 μg/mL, total volume 10 mL), delivered using a 27-gauge needle. Each session consisted of five symmetrical injections of 2 mL into the paravertebral cervical muscles.
Following the injection cycle, patients underwent a structured rehabilitation program based on the McKenzie method. Receives: Drug: Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program |
| Control group | Active comparator | Intramuscular paravertebral O₂O₃ therapy was administered by a physician specialized in Physical and Rehabilitation Medicine with expertise in ozone injections. All participants received 8 weekly cervical paravertebral injections of an O₂O₃ gas mixture (10 μg/mL, total volume 10 mL), delivered using a 27-gauge needle. Each session consisted of five symmetrical injections of 2 mL into the paravertebral cervical muscles.
Following the injection cycle, patients underwent a structured rehabilitation program based on the Back School method. Receives: Drug: Combined O₂O₃ Injection and back school Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a validated, self-reported questionnaire used to assess disability related to neck pain. It consists of 10 items evaluating pain intensity and its impact on daily activities, including personal care, lifting, reading, work, driving, sleeping, and recreation. Each item is scored from 0 (no disability) to 5 (maximum disability), with a total score ranging from 0 to 50. The final score is typically expressed as a percentage, with higher scores indicating greater disability.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Mar 2024
- Primary completion1 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Pain, PosteriorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De Sire Alessandro, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504432
- Sponsor's protocol ID
- 78/2024
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxygen-ozone Therapy and Cervical Rehabilitation on Functioning in Patients Affected by Nec
- ClinicalTrials.gov ID
- NCT07504432
- Acronym / sponsor ID
- 78/2024
- Conditions
- Cervical Pain, Posterior
- Keywords
- ozone therapy, cervical pain, physiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 31 Mar 2026 (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.
Neck pain represents one of the most prevalent and disabling musculoskeletal conditions worldwide, significantly affecting functional capacity, work productivity, and quality of life. Despite the availability of multiple conservative treatment strategies, there is still no clear consensus on the most effective rehabilitation approach, particularly when combining interventional and exercise-based therapies. In recent years, oxygen-ozone (O₂O₃) therapy has emerged as a promising minimally invasive treatment for musculoskeletal pain, due to its potential anti-inflammatory, analgesic, and microcirculatory effects. However, evidence regarding its integration with structured rehabilitation programs for neck pain remains limited.
The purpose of this prospective double-arm study was to evaluate the effectiveness of a combined therapeutic approach based on O₂O₃ paravertebral injections followed by cervical rehabilitation exercises. Specifically, the study aimed to compare two commonly used rehabilitation strategies-McKenzie-based therapy and Back School exercises-in order to determine which approach provides greater benefits when associated with O₂O₃ treatment.
The primary research question addressed whether the combination of O₂O₃ injections with McKenzie exercises leads to superior improvements in disability, compared to O₂O₃ combined with Back School. Secondary questions explored whether this combined approach is effective in reducing pain intensity and improving health-related quality of life in patients with chronic neck pain.
To answer these questions, patients with clinically significant neck pain were treated with a standardized O₂O₃ injection protocol and subsequently allocated to one of the two rehabilitation programs. Outcomes related to disability, pain, and quality of life were assessed across multiple time points to evaluate both short-term and follow-up effects.
Overall, this study seeks to clarify the added value of integrating interventional therapies with specific rehabilitation strategies and to identify the most effective combination for optimizing functional recovery in patients with neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Combined O₂O₃ Injection and McKenzie-Based Rehabilitation ProgramIntramuscular paravertebral O₂O₃ therapy was administered by a physician specialized in Physical and Rehabilitation Medicine with expertise in ozone injections. All participants received 8 weekly cervical paravertebral injections of an O₂O₃ gas mixture (10 μg/mL, total volume 10 mL), delivered using a 27-gauge needle. Each session consisted of five symmetrical injections of 2 mL into the paravertebral cervical muscles. Following the injection cycle, patients underwent a structured rehabilitation program based on the McKenzie method. |
| Control group | Active comparator | Drug: Combined O₂O₃ Injection and back school Rehabilitation ProgramIntramuscular paravertebral O₂O₃ therapy was administered by a physician specialized in Physical and Rehabilitation Medicine with expertise in ozone injections. All participants received 8 weekly cervical paravertebral injections of an O₂O₃ gas mixture (10 μg/mL, total volume 10 mL), delivered using a 27-gauge needle. Each session consisted of five symmetrical injections of 2 mL into the paravertebral cervical muscles. Following the injection cycle, patients underwent a structured rehabilitation program based on the Back School method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Diagnosis of neck pain lasting at least 12 weeks
- Moderate to severe pain (score ≥ 4 on a 0-10 pain scale)
- Presence of muscle pain (trigger points) in the neck region
- Willingness to stop pain medications or other treatments that could interfere with the study
Key exclusion criteria (7 listed)
- Cognitive impairment or inability to provide informed consent
- Current use of anti-inflammatory drugs, opioids, or ongoing rehabilitation treatments
- Neck pain caused by nerve damage, infections, tumors, or systemic diseases
- History of recent neck trauma or surgery
- Presence of serious medical conditions such as cancer, rheumatoid arthritis, fibromyalgia, thyroid disorders, or diabetes
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 |
|---|---|---|
| Combined O₂O₃ Injection and McKenzie-Based Rehabilitation ProgramIntramuscular paravertebral oxygen-ozone (O₂O₃) therapy was administered using a gas mixture at a concentration of 10 μg/mL, with a total volume of 10 mL per session. The treatment was delivered through five bilateral paravertebral cervical injections (2 mL per site) using a 27-gauge needle. Sessions were performed once weekly for 8 consecutive weeks. Following the injection phase, participants underwent a structured rehabilitation program based on the McKenzie method, consisting of 10 supervised sessions over a 2-week period, focused on repeated cervical movements, postural correction, and patient-directed exercises. | Drug | Study group |
| Combined O₂O₃ Injection and back school Rehabilitation ProgramIntramuscular paravertebral oxygen-ozone (O₂O₃) therapy was administered using a gas mixture at a concentration of 10 μg/mL, with a total volume of 10 mL per session. The treatment was delivered through five bilateral paravertebral cervical injections (2 mL per site) using a 27-gauge needle. Sessions were performed once weekly for 8 consecutive weeks. Following the injection phase, participants underwent a structured rehabilitation program based on the back school, consisting of 10 supervised sessions over a 2-week period, focused on repeated cervical movements, postural correction, and patient-directed exercises. | Drug | Control group |
Primary outcome
Neck Disability Index (NDI)
Time frame: From enrollment to the end of treatment at 24 weeks
The Neck Disability Index (NDI) is a validated, self-reported questionnaire used to assess disability related to neck pain. It consists of 10 items evaluating pain intensity and its impact on daily activities, including personal care, lifting, reading, work, driving, sleeping, and recreation. Each item is scored from 0 (no disability) to 5 (maximum disability), with a total score ranging from 0 to 50. The final score is typically expressed as a percentage, with higher scores indicating greater disability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program and Combined O₂O₃ Injection and back school Rehabilitation Program in people with Cervical Pain, Posterior, run by University of Catanzaro 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 6 Apr 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (NDI) (time frame: From enrollment to the end of treatment at 24 weeks). 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 6 Apr 2026.