- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404412
The Impact of Contrast Media Used in Epidural Steroid Injections on Thyroid Function Tests
The Impact of Contrast Media Used In Epidural Steroid Injections on Thyroid Function Tests
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: RIDVAN ISIK
- Phone Number: +905412427317
- Email: dr.ridvanisik@gmail.com
Study Contact Backup
- Name: SHAHIN AZIZOV
- Phone Number: +905360227187
- Email: shahinazizov1@gmail.com
Study Locations
-
-
Pendik
-
Istanbul, Pendik, Turkey, 34010
- Marmara University Pendik Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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.
|
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)
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.
|
Change of the values of TSH from baseline to each checkpoints from pre-interventional time to postinterventional 3rd week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SAVAS SENCAN, Marmara University Pendik Training and Research Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07.01.2022.83
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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