NCT06551792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

April 24, 2024

Last Update Submit

December 5, 2025

Conditions

Keywords

pain,magnesium level, disc herniation

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Oswestry Disability Index

    3 months

Study Arms (1)

Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection

Transforaminal Epidural Steroid Injection groups

Other: Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection

Interventions

Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection

Effect of Serum Magnesium Level on the Success of Transforaminal Epidural Steroid Injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Back PainIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pain specialist

Study Record Dates

First Submitted

April 24, 2024

First Posted

August 13, 2024

Study Start

June 1, 2024

Primary Completion

August 30, 2024

Study Completion

September 15, 2024

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations