Clinical trial NCT02834676: Clinical Effects of Gelified Ethanol Application in Cervical Disc Hernia
Official title: Retrospective Evaluation of Treatment of Chronic Pain Related to Cervical Disc Hernia Using Chemonucleolysis Substance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Keywords: DiscoGel(R)
gelified ethanol
percutaneous treatment
Oswestry Disability Index (ODI)
Visual analog Scale (VAS)
Neuropathic Pain Questionnaire (DN-4)
cervical
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: DiscoGel technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0
timeFrame: 1 month
Secondary outcomes:
measure: Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0
timeFrame: 3 months
measure: Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0
timeFrame: 1 month
measure: DiscoGel technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0
timeFrame: 3 months
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Research and Training Hospital
Study officials:
affiliation: Clinical Chair
name: Serbülent G Beyaz, AssocProf
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Theron 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.
citation: Stagni 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.