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Completed

NCT Number: NCT05404412

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural steroid injection

Procedure

This intervention is applied mostly for cervical or lumbar radiculopathy. 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 a combined local anesthetic and glucocorticoids are delivered to the epidural space.

Primary outcomes

  1. The Values of free T4

    Time frame: 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

  2. The Values of free T3

    Time frame: 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.

  3. The Values of Thyroid-stimülating hormone (TSH)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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