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Clinical Trials/NCT05374850
NCT05374850
Unknown
Not Applicable

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

Marmara University1 site in 1 country60 target enrollmentJune 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Disc Herniation
Sponsor
Marmara University
Enrollment
60
Locations
1
Primary Endpoint
Numeric Rating Scale (NRS)
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2022
End Date
August 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Short-form 12(SF-12)(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)(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)

Study Sites (1)

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