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Clinical Effects of Gelified Ethanol Application in Cervical Disc Hernia

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02834676
Enrollment
35
Registered
2016-07-15
Start date
2016-06-30
Completion date
2017-07-31
Last updated
2016-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

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

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.

Interventions

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

Sponsors

Sakarya University
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DiscoGel technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.01 monthStatistical 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

Secondary

MeasureTime frameDescription
Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.03 monthsStatistical assessment of each patient was evaluated on time intervals before procedure, in the 3rd months after procedure for ODI score
DiscoGel technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.03 monthsStatistical 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

Countries

Turkey (Türkiye)

Contacts

Primary ContactHavva Sayhan, Assis Prof
hsayhan@gmail.com+905056621021
Backup ContactAhmet Celiktas, Resident
celiktas@gmail.com+905515567165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026