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

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404412
• Other study ID #: 07.01.2022.83
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: February 3, 2023

Study information

• Verified date: April 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 3, 2023
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Cervical Stenosis
• Constriction, Pathologic
• Lumbar Radiculopathy
• Lumbar Spinal Stenosis
• Radiculopathy
• Spinal Stenosis

Intervention

Procedure:
• Epidural Steroid Injection
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.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Kim YU, Kim D, Park JY, Choi JH, Kim JH, Bae HY, Joo EY, Suh JH. Method to Reduce the False-Positive Rate of Loss of Resistance in the Cervical Epidural Region. Pain Res Manag. 2016;2016:9894054. doi: 10.1155/2016/9894054. Epub 2016 Mar 29. — View Citation

Kornelius E, Chiou JY, Yang YS, Peng CH, Lai YR, Huang CN. Iodinated Contrast Media Increased the Risk of Thyroid Dysfunction: A 6-Year Retrospective Cohort Study. J Clin Endocrinol Metab. 2015 Sep;100(9):3372-9. doi: 10.1210/JC.2015-2329. Epub 2015 Jul 13. — View Citation

Manchikanti L, Knezevic NN, Navani A, Christo PJ, Limerick G, Calodney AK, Grider J, Harned ME, Cintron L, Gharibo CG, Shah S, Nampiaparampil DE, Candido KD, Soin A, Kaye AD, Kosanovic R, Magee TR, Beall DP, Atluri S, Gupta M, Helm Ii S, Wargo BW, Diwan S, Aydin SM, Boswell MV, Haney BW, Albers SL, Latchaw R, Abd-Elsayed A, Conn A, Hansen H, Simopoulos TT, Swicegood JR, Bryce DA, Singh V, Abdi S, Bakshi S, Buenaventura RM, Cabaret JA, Jameson J, Jha S, Kaye AM, Pasupuleti R, Rajput K, Sanapati MR, Sehgal N, Trescot AM, Racz GB, Gupta S, Sharma ML, Grami V, Parr AT, Knezevic E, Datta S, Patel KG, Tracy DH, Cordner HJ, Snook LT, Benyamin RM, Hirsch JA. Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines. Pain Physician. 2021 Jan;24(S1):S27-S208. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Values of free T4	Free T4 is a type of thyroid hormone. A free T4 test is used to evaluate thyroid function	Change of the values of free T4 from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week
Primary	The Values of free T3	The free T3 is an another major hormone of the thyroid gland. It is used to show thyroid functions.	Change of the values of free T3 from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week
Primary	The Values of Thyroid-stimülating hormone (TSH)	TSH is secreted from the pituitary gland to stimulate the thyroid gland. It regulates thyroid functions. This test is also used for thyroid functions.	Change of the values of TSH from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week