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

M

Marmara University

Status

Unknown

Conditions

Cervical Disc Herniation

Treatments

Procedure: Cervical Interlaminar Epidural Steroid Injection

Study type

Observational

Funder types

Other

Identifiers

NCT05374850
07.01.2022.82

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

JANBUBI JANDAULYET; RIDVAN ISIK

Data sourced from clinicaltrials.gov

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