Clinical Effects of Gelified Ethanol Application in Cervical Disc Hernia

Last updated: July 12, 2016
Sponsor: Sakarya University
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Pain

Treatment

N/A

Clinical Study ID

NCT02834676
Sakarya Cervical
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • continuous radicular pain radiating to the upper limb, with a duration ≥8 weeks and anintensity >4/10 as rated by the patient on a visual analog scale (VAS)

  • resistant to appropriate conservative treatment combining anti-inflammatory drugs andozone-oxygen therapy, and confirmed by imaging with CT or MRI of a herniated discputting pressure on a nerve root consistent with the clinical pain.

Exclusion

Exclusion Criteria:

  • history of surgery at the cervical spine, contraindication to percutaneouschemonucleolysis (coagulopathy or infection), imaging results that did not support theclinical 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

Total Participants: 35
Study Start date:
June 01, 2016
Estimated Completion Date:
July 31, 2017

Study 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.

Connect with a study center

  • Sakarya University Research and Training Hospital

    Sakarya, 54100
    Turkey

    Active - Recruiting

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