The Impact of Contrast Media Used in Epidural Steroid Injections on Thyroid Function Tests

Completed

• Conditions: Cervical Stenosis; Lumbar Spinal Stenosis; Cervical Radiculopathy; Lumbar Radiculopathy

• Registration Number: NCT05404412
• Lead Sponsor: Marmara University

Brief Summary

This study is aim to disclose the effect of contrast media, which used in epidural steroid injections, on the parameters of thyroid function tests (TFTs). The patients who underwent an epidural steroid injection were included. The investigators hypothesized that contrast media owing to contain iodine may impair the values of TFTs.

Detailed Description

The objective of this study is to reveal the impact of contrast media, whether they change the values of TFTs in participants who had been performed any kind of epidural steroid injection such as Lumbar, cervical and caudal epidural steroid injection. The inclusion criteria were participants who had normal values of TFTs, being between the ages of 18 and 65 and had an epidural steroid injection. Patients with impaired parameters of TFTs or had thyroid surgery, 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 conjunction with the recording of the demographic data of the patients participating in this study (age, sex, duration of symptoms, etc.), their contrast medium doses and the values of TFTs (free T3, free T4 and Thyroid-stimulating hormone) were employed before the procedure and 3rd week after the procedure.

Study Timeline

• Study First Submitted: 2022-05-29
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-03
• Primary Completion: 2022-07-15
• Study Completion: 2023-02-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Patients who will be performing with an epidural steroid injection
• Being between the ages of 18 and 65
• Having normal values of Thyroid function tests

Exclusion Criteria

• Patients with a history of thyroid surgery or impaired thyroid function tests
• 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
The Values of free T3	Change of the values of free T3 from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week	The free T3 is an another major hormone of the thyroid gland. It is used to show thyroid functions.
The Values of Thyroid-stimülating hormone (TSH)	Change of the values of TSH from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week	TSH is secreted from the pituitary gland to stimulate the thyroid gland. It regulates thyroid functions. This test is also used for thyroid functions.
The Values of free T4	Change of the values of free T4 from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week	Free T4 is a type of thyroid hormone. A free T4 test is used to evaluate thyroid function

Trial Locations

Locations (1)

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