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

• Conditions: Cervical Disc Herniation

• Registration Number: NCT05374850
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study First Submitted: 2022-04-20
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-10
• Last Update Submitted: 2022-05-10
• Study First Posted: 2022-05-16
• Last Update Posted: 2022-05-16
• Study Start: 2022-06
• Primary Completion: 2022-06
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS)	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 Outcome Measures

Name	Time	Method
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 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.
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	Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.

Trial Locations

Locations (1)

Marmara University Pendik Training and Research Hospital; 🇹🇷 Istanbul, Turkey