Impact of Cervical Parameters to Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation

May 10, 2022 updated by: Marmara University

Impact of Cervical Sagittal Parameters on Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation

This study is aim to disclose the effect of cervical parameters, whether they change the outcomes of epidural steroid injection treatment in patients with cervical disc herniation. The patients who had cervical disc herniation and had been performed interlaminar epidural steroid injection were included. We hypothesized that participants with abnormal cervical spine alignment parameters were less likely to benefit from treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to reveal the impact of cervical sagittal parameters on interlaminar epidural steroid injections in patients with cervical disc herniation. Patients who have suffered from cervical radicular pain for at least 3 months and been diagnosed with cervical radiculopathy in our pain clinic in the subsequent stage, with a clinical and physical examination, as well as radiologic assessments, were included in the study. Other inclusion criteria were intractable pain over the neck despite conservative treatment and being between the ages of 18 and 65. Patients with a history of epidural steroid injections carried out in the previous 3 months, patients with a history of cervical spine surgery, patients with systemic and/or local infections, malignancy, bleeding diathesis, acute fracture, known allergy to contrast material and/or local anesthetic substances, known history of any psychiatric disorder, and patients with a history of pregnancy were excluded from the study. Verbal and written informed consent was obtained from all patients participating in the study.

In addition to the recording of the demographic data of the patients participating in this study (age, sex, duration of symptoms, etc.), their sagittal parameters angles (C2-C7 cervical lordosis, C2-C7 sagittal vertical axis, C7 slope and spino-cranial angle) and the numeric rating scale (NRS) was employed before the procedure and in the 1st hour, 3rd week, and 3rd month after the procedure. Short Form-12 Health Survey (SF-12) was employed before the procedure and in the 3rd week and 3rd month after the procedure.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Marmara University Pendik Training and Research Hospital
        • Contact:
        • Principal Investigator:
          • SAVAS SENCAN
        • Principal Investigator:
          • RIDVAN ISIK
        • Sub-Investigator:
          • JANBUBI JANDAULYET
        • Sub-Investigator:
          • OSMAN HAKAN GUNDUZ

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients ,between the ages of 18 and 65, who diagnosed with cervical radiculopathy due to disc herniation in our pain clinic and who are resistant to conservative treatment, so the patients to be treated with ILESI procedure.

Description

Inclusion Criteria:

  • Patients who have suffered from neck pain for at least 3 months and been diagnosed with cervical radiculopathy
  • Intractable pain despite conservative treatment and being between the ages of 18 and 65
  • Patients who will be performing with an interlaminar epidural steroid injection(ILESI)

Exclusion Criteria:

  • Patients with a history of ILESI carried out in the previous 3 months,
  • Patients with a history of cervical surgery,
  • Patients with systemic and/or local infections,
  • Malignancy,
  • Bleeding diathesis,
  • Acute fracture,
  • Known allergy to contrast material and/or local anesthetic substances,
  • Known history of any psychiatric disorder
  • Patients with a history of pregnancy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS)
Time Frame: Change of pain severity from baseline to each checkpoints from pre-interventional time to post-interventional 1st hour, 3rd week and 3rd month
A numeric (or numerical) scale, also known as a Numerical Rating Scale (NRS), is basically any scale that renders a quantitative symbolization of an attribute. This type of scale is used by presenting the respondent with an ordered set from which to choose, for example, 1 to 10, coupled with anchors. These anchors can be put at the endpoints or at each point on the scale.
Change of pain severity from baseline to each checkpoints from pre-interventional time to post-interventional 1st hour, 3rd week and 3rd month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-form 12(SF-12)
Time Frame: Change of life quality from baseline to each checkpoints from pre-interventional time to post-interventional 3rd week and 3rd month
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Change of life quality from baseline to each checkpoints from pre-interventional time to post-interventional 3rd week and 3rd month
The Neck Disability Index (NDI)
Time Frame: Change of functionality from baseline to each checkpoints from baseline to each checkpoints from pre-interventional time to post-interventional 3rd week and 3rd month
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
Change of functionality from baseline to each checkpoints from baseline to each checkpoints from pre-interventional time to post-interventional 3rd week and 3rd month

Collaborators and Investigators

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

Sponsor

Marmara University

Investigators

  • Principal Investigator: SAVAS SENCAN, Marmara University Pendik Training and Research Hospital

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 (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.01.2022.82

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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