Pain, BackNCT06551792
The Effect of Magnesium Deficiency on Transforaminal Epidural Steroid Injection Success: An Observational Study
An observational study of Pain, Back, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Back
- What is being tested?
- Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection
- Type of treatment
- Injection or infusion
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 34000
About this study
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.
Read the 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.
- Conditions
- Pain, Back
- Being tested
- Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection
- Keywords
- pain,magnesium level, disc herniation
- Medical subject headings
- Back Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid InjectionOther
Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection
| Study group | Role | What they receive |
|---|---|---|
| Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection | Transforaminal Epidural Steroid Injection groups Receives: Other: Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale-11 (NRS-11)
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.
Measured: 3 months
Secondary outcomes (1)
Oswestry Disability Index
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jun 2024
- Primary completion30 Aug 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, BackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551792
- Sponsor's protocol ID
- KanuniSS
- Status last verified
- Dec 2025
- First submitted
- 24 Apr 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Deficiency on Transforaminal Epidural Steroid Injection Success: An Observational Study
- ClinicalTrials.gov ID
- NCT06551792
- Acronym / sponsor ID
- KanuniSS
- Conditions
- Pain, Back
- Keywords
- pain,magnesium level, disc herniation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection | – | Other: Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection groups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid InjectionEffect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection | Other | Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection |
Primary outcome
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.
1 secondary outcome
Oswestry Disability Index
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Back, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale-11 (NRS-11) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.