Clinical trial NCT06551792: Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection
Official title: Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain, Back
Keywords: pain,magnesium level, disc herniation
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: In this study, serum magnesium levels before the procedure are effective in the success of
timeFrame: There is a correlation between intracellular magnesium deficiency and serum magnesium levels
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References: