Clinical Effects of Gelified Ethanol Application in Cervical Disc Hernia

NCT02834676 | Unknown

• 1 other identifier: Sakarya Cervical
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

DiscoGel(R); gelified ethanol; percutaneous treatment; Oswestry Disability Index (ODI); Visual analog Scale (VAS); Neuropathic Pain Questionnaire (DN-4); cervical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0

  3 months

• Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0

  1 month

• DiscoGel technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0

  3 months

Study Arms (1)

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.

Drug: Gelified Ethanol

Interventions

Gelified Ethanol DRUG

Pain relief with chemonucleolysis by using gelified ethanol regard to age, sex, ASA score, and complications.

Also known as: DiscoGel

Chemonucleolysis by Gelified Ethanol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Research and Training Hospital

Sakarya, 54100, Turkey (Türkiye)

RECRUITING

Related 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 80 patients. AJNR Am J Neuroradiol. 2015 Mar;36(3):600-5. doi: 10.3174/ajnr.A4166. Epub 2014 Nov 13.

  PMID: 25395657 RESULT

• 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.

  PMID: 20053805 RESULT

• 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.

  PMID: 22440607 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serbülent G Beyaz, AssocProf

  Clinical Chair

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Havva Sayhan, Assis Prof

CONTACT

+905056621021; hsayhan@gmail.com

Ahmet Celiktas, Resident

CONTACT

+905515567165; celiktas@gmail.com

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 15, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 15, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)