Clinical Effects of Gelified Ethanol Application in Cervical Disc Hernia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retrospective Evaluation of Treatment of Chronic Pain Related to Cervical Disc Hernia Using Chemonucleolysis Substance

Conditions
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Pain

Intervention / Treatment
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* Drug: Gelified Ethanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemonucleolysis by Gelified Ethanol<br>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. | Drug: Gelified Ethanol<br>* Pain relief with chemonucleolysis by using gelified ethanol regard to age, sex, ASA score, and complications.<br>* Other names: DiscoGel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical, DiscoGel(R), gelified ethanol, percutaneous treatment, Oswestry Disability Index (ODI), Visual analog Scale (VAS), Neuropathic Pain Questionnaire (DN-4)