Clinical Trials Directory

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UnknownNCT05374850

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Marmara University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECervical Interlaminar Epidural Steroid InjectionThis intervention is applied mostly for cervical disc herniation.The intervention was carried out under sterile conditions with the C-arm fluoroscopy guidance. It is performed via spinal needle and the needle is inserted into the epidural space, then combined local anesthetics and glucocorticoids is delivered to the epidural space.

Timeline

Start date
2022-06-01
Primary completion
2022-06-01
Completion
2022-08-01
First posted
2022-05-16
Last updated
2022-05-16

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05374850. Inclusion in this directory is not an endorsement.