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

NCT05404412 | Completed

• 1 other identifier: 07.01.2022.83
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Radiculopathy; Lumbar Spinal Stenosis; Cervical Radiculopathy; Cervical Stenosis

Keywords

thyroid functions; epidural steroid injections

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients, between the ages of 18 and 65, who have normal values of thyroid function tests and who will be performing an epidural steroid injection.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34010, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33492918 BACKGROUND

• 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.

  PMID: 27445637 BACKGROUND

• 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.

  PMID: 26168278 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Spinal Stenosis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• SAVAS SENCAN

  Marmara University Pendik Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 3, 2022
• Study Start: June 1, 2022
• Primary Completion: July 15, 2022
• Study Completion: February 3, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)