Clinical Effects of Gelified Ethanol Application in Cervical Disc Hernia

July 12, 2016 updated by: Havva Sayhan, Sakarya University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Sakarya, Turkey, 54100
        • Recruiting
        • Sakarya University Research and Training hospital
        • Contact:
        • Contact:
          • Serbülent G Beyaz, Assoc Prof
          • Phone Number: 6166 +90 264 8884051
          • Email: sgbeyaz@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Pain relief with chemonucleolysis by using gelified ethanol regard to age, sex, ASA score, and complications.
Other Names:
  • DiscoGel

What is the study measuring?

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
Time Frame: 1 month
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
Time Frame: 3 months
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
Time Frame: 1 month
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
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Investigators

  • Principal Investigator: Serbülent G Beyaz, AssocProf, Clinical Chair

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 1, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sakarya Cervical

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Gelified Ethanol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe