Clinical Effects of Gelified Ethanol Application in Cervical Disc Hernia

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02834676
• Other study ID #: Sakarya Cervical
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2016
• Last updated: July 12, 2016
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: Sakarya University
• Contact: Havva Sayhan, Assis Prof
• Phone: +905056621021
• Email: hsayhan[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Gelified Ethanol
Pain relief with chemonucleolysis by using gelified ethanol regard to age, sex, ASA score, and complications.

Locations

Country	Name	City	State
Turkey	Sakarya University Research and Training Hospital	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View 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® chemonucleolysis in patients unresponsive to chemonucleolysis with oxygen-ozone. Interv Neu — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No