PainNCT02834676
Clinical Effects of Gelified Ethanol Application in Cervical Disc Hernia
An observational study of Pain, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the clinical effects of Discogel® Radiopaque Gelified Ethanol 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
- What is being tested?
- Gelified Ethanol
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Jul 2017
- 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 and ozone-oxygen 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 anti-inflammatory drugs and ozone-oxygen therapy, 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 G Beyaz, Assoc Prof, +90 264 8884051 ext. 6166, sgbeyaz@gmail.com
About this study
Official title: Retrospective Evaluation of Treatment of Chronic Pain Related to Cervical Disc Hernia Using Chemonucleolysis Substance
The aim of the study is to evaluate the clinical effects of Discogel® Radiopaque Gelified Ethanol 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 DiscoGel® for cervical discogenic or radicular pain that did not resolve after the use of conventional therapy and ozone-oxygen therapy.
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
- Being tested
- Gelified Ethanol
- Keywords
- DiscoGel(R), gelified ethanol, percutaneous treatment, Oswestry Disability Index (ODI), Visual analog Scale (VAS), Neuropathic Pain Questionnaire (DN-4), cervical
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelified EthanolDrug
Also called DiscoGel
Pain relief with chemonucleolysis by using gelified ethanol regard to age, sex, ASA score, and complications.
| Study group | Role | What they receive |
|---|---|---|
| Chemonucleolysis by Gelified Ethanol | 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 and ozone-oxygen therapy. Written informed consent was obtained from all participants. Receives: Drug: Gelified Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
DiscoGel 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 (3)
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
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
DiscoGel 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 3rd months after procedure for Visual analogue scale (VAS) score for pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Time perspective
- Retrospective
- Enrolment
- 35 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 G Beyaz, AssocProf, Principal investigator, Clinical Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834676
- Sponsor's protocol ID
- Sakarya Cervical
- Status last verified
- Jul 2016
- First submitted
- 1 Jul 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bellini M, Romano DG, Leonini S, Grazzini I, Tabano C, Ferrara M, Piu P, Monti L, Cerase A. Percutaneous injection of radiopaque gelified ethanol for the treatment of lumbar and cervical intervertebral disk herniations: experience and clinical outcome in 80 patients. AJNR Am J Neuroradiol. 2015 Mar;36(3):600-5. doi: 10.3174/ajnr.A4166. Epub 2014 Nov 13.
PubMed 25395657Theron J, Cuellar H, Sola T, Guimaraens L, Casasco A, Courtheoux P. Percutaneous treatment of cervical disk hernias using gelified ethanol. AJNR Am J Neuroradiol. 2010 Sep;31(8):1454-6. doi: 10.3174/ajnr.A1923. Epub 2010 Jan 6.
PubMed 20053805Stagni S, de Santis F, Cirillo L, Dall'olio M, Princiotta C, Simonetti L, Stafa A, Leonardi M. A minimally invasive treatment for lumbar disc herniation: DiscoGel(R) chemonucleolysis in patients unresponsive to chemonucleolysis with oxygen-ozone. Interv Neuroradiol. 2012 Mar;18(1):97-104. doi: 10.1177/159101991201800113. Epub 2012 Mar 16.
PubMed 22440607
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Treatment of Chronic Pain Related to Cervical Disc Hernia Using Chemonucleolysis Substance
- ClinicalTrials.gov ID
- NCT02834676
- Acronym / sponsor ID
- Sakarya Cervical
- Conditions
- Pain
- Keywords
- DiscoGel(R), gelified ethanol, percutaneous treatment, Oswestry Disability Index (ODI), Visual analog Scale (VAS), Neuropathic Pain Questionnaire (DN-4), cervical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 15 Jul 2016 (estimated)
- 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 Discogel® Radiopaque Gelified Ethanol 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 DiscoGel® for cervical discogenic or radicular pain that did not resolve after the use of conventional therapy and ozone-oxygen therapy.
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
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemonucleolysis by Gelified Ethanol | – | Drug: Gelified EthanolPatients visiting the pain clinic of the hospital who had cervical discogenic or radicular pain that did not resolve after the use of conventional therapy and ozone-oxygen 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 and ozone-oxygen 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 anti-inflammatory drugs and ozone-oxygen therapy, 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 |
|---|---|---|
| Gelified EthanolAlso: DiscoGelPain relief with chemonucleolysis by using gelified ethanol regard to age, sex, ASA score, and complications. | Drug | Chemonucleolysis by Gelified Ethanol |
Primary outcome
DiscoGel technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0
Time frame: 1 month
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
3 secondary outcomes
Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0
Time frame: 3 months
Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0
Time frame: 1 month
DiscoGel technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Results publication: PubMed 25395657Bellini M, Romano DG, Leonini S, Grazzini I, Tabano C, Ferrara M, Piu P, Monti L, Cerase A. Percutaneous injection of radiopaque gelified ethanol for the treatment of lumbar and cervical intervertebral disk herniations: experience and clinical outcome in 80 patients. AJNR Am J Neuroradiol. 2015 Mar;36(3):600-5. doi: 10.3174/ajnr.A4166. Epub 2014 Nov 13.
- Results publication: PubMed 20053805Theron J, Cuellar H, Sola T, Guimaraens L, Casasco A, Courtheoux P. Percutaneous treatment of cervical disk hernias using gelified ethanol. AJNR Am J Neuroradiol. 2010 Sep;31(8):1454-6. doi: 10.3174/ajnr.A1923. Epub 2010 Jan 6.
- Results publication: PubMed 22440607Stagni S, de Santis F, Cirillo L, Dall'olio M, Princiotta C, Simonetti L, Stafa A, Leonardi M. A minimally invasive treatment for lumbar disc herniation: DiscoGel(R) chemonucleolysis in patients unresponsive to chemonucleolysis with oxygen-ozone. Interv Neuroradiol. 2012 Mar;18(1):97-104. doi: 10.1177/159101991201800113. Epub 2012 Mar 16.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 G Beyaz, AssocProf principal investigator
Clinical Chair
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, 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 15 Jul 2016. 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?
DiscoGel technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0 (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 NCT02834676, which also lists 3 linked publications.
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 15 Jul 2016.