Clinical trial NCT05404412: The Impact of Contrast Media Used in Epidural Steroid Injections on Thyroid Function Tests
Official title: The Impact of Contrast Media Used In Epidural Steroid Injections on Thyroid Function Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Radiculopathy
Lumbar Spinal Stenosis
Cervical Radiculopathy
Cervical Stenosis
Keywords: thyroid functions
epidural steroid injections
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Values of free T4
timeFrame: Change of the values of free T4 from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week
measure: The Values of free T3
timeFrame: Change of the values of free T3 from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week
measure: The Values of Thyroid-stimülating hormone (TSH)
timeFrame: Change of the values of TSH from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
state: Pendik
Study officials:
affiliation: Marmara University Pendik Training and Research Hospital
name: SAVAS SENCAN
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.