- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06551792
The Effect of Magnesium Deficiency on Transforaminal Epidural Steroid Injection Success: An Observational Study
December 5, 2025 updated by: Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
Transforaminal epidural steroid injection (TFESE) is an interventional method frequently used in the treatment of radicular pain due to disc herniation.
TFESE, which is applied under sterile conditions and under fluoroscopy guidance, increases its effectiveness when applied in the early period (first 3 months).
Inflammation and increase in neurotransmitters in the nerve root due to disc herniation trigger pain.
Steroids and local anesthetics applied to the nerve root with TFESE exhibit strong anti-inflammatory effects.
Factors affecting the success of TFESE include the type and dose of drugs, the age of the patient, any accompanying comorbidities, the level of injection administered and other musculoskeletal problems.
Studies on the effect of these parameters on the effectiveness of TFESE are limited.Cardiac arrhythmia, muscle spasms, tetany, fasciculation paresthesia, widespread body pain, impaired bone mineralization, electrolyte disorders such as hypokalemia, hypocalcemia, hypophosphatemia, depression, and seizures may occur due to magnesium deficiency.
One of the most important causes of low back pain is degenerative disc disease, and magnesium deficiency has been shown to be associated with low back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted by retrospectively scanning the files of patients with paracentral/subarticular protruded disc herniation and who underwent transforaminal epidural steroid injection (TFESE) to the lumbosacral region, at the Algology Department of Kanuni Sultan Süleyman Training and Research Hospital, between January 2022 and January 2024.
In order to prevent heterogeneity, magnetic resonance imaging (MRI) of the patients will be evaluated in consultation with a radiologist.
The common consensus classification created by the American Society of Spine Radiology (ASSR), American Society of Neuroradiology (ASNR) and North American Spine Society (NASS) is used to classify disc herniations.
will be used.
Numeric Rating Scale-11 (NRS) and Oswestry Disability Index (ODI) will be recorded from the patients' files before the procedure, in the first month and in the third month to evaluate age, gender, symptom duration, pain and functionality.
The initial pain severity of the patients will be determined by the NRS-11 score, and a decrease of 50% or more in the NRS-11 score in the first month after the procedure will be considered as benefiting from the treatment.
The Mg level of the patients before the procedure will be scanned in the hospital system and those that can be accessed will be recorded.
Study Type
Observational
Enrollment (Actual)
118
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34000
- Kanuni Sultan Suleyman Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Inclusion Criteria:
- Patients with paracentral/subarticular protruded disc herniation who underwent transforaminal epidural steroid injection (TFESE) to the lumbosacral region
- Patients with complete data to be scanned in their files
Description
Exclusion Criteria:
- Patients whose medical analgesic treatment was changed during their three-month follow-up;
- Those with fibromyalgia;
- Those with metabolic diseases (chronic renal failure, spondyloarthropathies, diabetes, hypo/hyperthyroidism, etc.) that may affect serum magnesium level;
- Those with a history of lumbar surgery;
- those taking magnesium or calcium supplements;
- Those with malignancy or obesity;
- Those with psychiatric illness;
- Those without lumbar MRI; Patients whose clinical, physical examination and laboratory data cannot be accessed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection
Transforaminal Epidural Steroid Injection groups
|
Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale-11 (NRS-11)
Time Frame: 3 months
|
It is an 11-point scale used to describe pain.
It is based solely on the patient ability to perform activities of daily living and can be used for adults and children ages 10 and older.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index
Time Frame: 3 months
|
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Actual)
August 30, 2024
Study Completion (Actual)
September 15, 2024
Study Registration Dates
First Submitted
April 24, 2024
First Submitted That Met QC Criteria
August 11, 2024
First Posted (Actual)
August 13, 2024
Study Record Updates
Last Update Posted (Actual)
December 12, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KanuniSS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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