Pain, NeckNCT03056911
Clinical Effects of Ozone Therapy in Cervical Disc Hernia
An observational study of Pain, Neck, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the clinical effects of Ozone-oxygen therapy as therapeutic substance for nucleolysis application in the patients with cervical disc hernia who had chronic pain and weakness on the neck, shoulders and arms Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Neck
- What is being tested?
- Ozone
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 1 Jan 2019
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted from November 2013 to May 2016 on patients visiting the pain clinic who had cervical diskogenic or radicular pain that did not resolve after the use of conventional therapy.
Who may be able to join
- continuous radicular pain radiating to the upper limb, with a duration ≥8 weeks and an intensity >4/10 as rated by the patient on a visual analog scale (VAS)
- resistant to appropriate conservative treatment combining antiinflammatory drugs, and confirmed by imaging with CT or MRI of a herniated disc putting pressure on a nerve root consistent with the clinical pain.
Who cannot join
- history of surgery at the cervical spine, contraindication to percutaneous chemonucleolysis (coagulopathy or infection), imaging results that did not support the clinical results, the presence of a herniated disc excluded or calcified on imaging, possible interference with pain evaluation due to any medical condition or treatment, involvement of incomplete data collection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University Research and Training Hospital
Sakarya, 54100
Havva Sayhan, Assis Prof, +905056621021, hsayhan@gmail.com
Serbülent Beyaz, Assoc Prof, +90 264 8884051 ext. 6166, sgbeyaz@gmail.com
About this study
The aim of the study is to evaluate the clinical effects of Ozone-oxygen therapy as therapeutic substance for nucleolysis application in the patients with cervical disc hernia who had chronic pain and weakness on the neck, shoulders and arms
Read the detailed description
This is a retrospective, single-center study that is going to be conducted from November 2013 to May 2016 on patients visiting the pain clinic of the hospital who were treated with Ozone-oxygen therapy for cervical discogenic or radicular pain.
Data collected from medical record forms and electronic medical record system of the hospital were used in the retrospective analysis of medical data with regard to age, gender, complications.
A resident who has not involved in the study interviewed each patient by telephone on the follow up to collect the related information.
- Conditions
- Pain, Neck
- Being tested
- Ozone
- Keywords
- ozone therapy, percutaneous treatment, Oswestry Disability Index (ODI), Visual analog Scale (VAS), Neuropathic Pain Questionnaire (DN-4), cervical
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDrug
Pain relief with chemonucleolysis by using ozone regard to age, sex, ASA score, and complications.
| Study group | Role | What they receive |
|---|---|---|
| ozone | Chemonucleolysis by ozone therapy Patients visiting the pain clinic of the hospital who had cervical discogenic or radicular pain that did not resolve after the use of conventional therapy. Written informed consent was obtained from all participants. Receives: Drug: Ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) score for pain
Ozone therapy technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0 Statistical assessment of each patient was evaluated on time intervals before procedure, in the 1st month after procedure for Visual analogue scale (VAS) score for pain
Measured: 1 month
Secondary outcomes (2)
Oswestry Disability Index (ODI) score
Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0 Statistical assessment of each patient was evaluated on time intervals before procedure, in the 3rd months after procedure for ODI score
Measured: 3 months
ODI score
Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0 Statistical assessment of each patient was evaluated on time intervals before procedure, in the 1st month after procedure for ODI score
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, NeckStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Sayhan, Sakarya University
- Investigators
- Serbülent Beyaz, AssocProf, Study chair, Sakarya University Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056911
- Sponsor's protocol ID
- sakarya Ozone
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Magalhaes FN, Dotta L, Sasse A, Teixera MJ, Fonoff ET. Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. 2012 Mar-Apr;15(2):E115-29.
PubMed 22430658
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Ozone Therapy in Cervical Disc Hernia
- ClinicalTrials.gov ID
- NCT03056911
- Acronym / sponsor ID
- sakarya Ozone
- Conditions
- Pain, Neck
- Keywords
- ozone therapy, percutaneous treatment, Oswestry Disability Index (ODI), Visual analog Scale (VAS), Neuropathic Pain Questionnaire (DN-4), cervical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 17 Feb 2017 (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 the study is to evaluate the clinical effects of Ozone-oxygen therapy as therapeutic substance for nucleolysis application in the patients with cervical disc hernia who had chronic pain and weakness on the neck, shoulders and arms
Detailed description
This is a retrospective, single-center study that is going to be conducted from November 2013 to May 2016 on patients visiting the pain clinic of the hospital who were treated with Ozone-oxygen therapy for cervical discogenic or radicular pain.
Data collected from medical record forms and electronic medical record system of the hospital were used in the retrospective analysis of medical data with regard to age, gender, complications.
A resident who has not involved in the study interviewed each patient by telephone on the follow up to collect the related information.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ozone | – | Drug: OzoneChemonucleolysis by ozone therapy Patients visiting the pain clinic of the hospital who had cervical discogenic or radicular pain that did not resolve after the use of conventional therapy. Written informed consent was obtained from all participants. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted from November 2013 to May 2016 on patients visiting the pain clinic who had cervical diskogenic or radicular pain that did not resolve after the use of conventional therapy.
Key inclusion criteria (2 listed)
- continuous radicular pain radiating to the upper limb, with a duration ≥8 weeks and an intensity >4/10 as rated by the patient on a visual analog scale (VAS)
- resistant to appropriate conservative treatment combining antiinflammatory drugs, and confirmed by imaging with CT or MRI of a herniated disc putting pressure on a nerve root consistent with the clinical pain.
Key exclusion criteria (1 listed)
- history of surgery at the cervical spine, contraindication to percutaneous chemonucleolysis (coagulopathy or infection), imaging results that did not support the clinical results, the presence of a herniated disc excluded or calcified on imaging, possible interference with pain evaluation due to any medical condition or treatment, involvement of incomplete data collection
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 |
|---|---|---|
| OzonePain relief with chemonucleolysis by using ozone regard to age, sex, ASA score, and complications. | Drug | ozone |
Primary outcome
Visual analogue scale (VAS) score for pain
Time frame: 1 month
Ozone therapy technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0 Statistical assessment of each patient was evaluated on time intervals before procedure, in the 1st month after procedure for Visual analogue scale (VAS) score for pain
2 secondary outcomes
Oswestry Disability Index (ODI) score
Time frame: 3 months
ODI score
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Results publication: PubMed 22430658Magalhaes FN, Dotta L, Sasse A, Teixera MJ, Fonoff ET. Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. 2012 Mar-Apr;15(2):E115-29.
- Individual participant dataSharing planned: Undecided
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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.
Serbülent Beyaz, AssocProf study chair
Sakarya University Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Neck, run by Sakarya University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 17 Feb 2017. 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 Turkey (Türkiye). 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.
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 Havva Sayhan, Assis Prof (+905056621021, hsayhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) score for pain (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03056911, which also lists 1 linked publication.
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 17 Feb 2017.