Marmara University Faculty of Medicine
Istanbul, PENDİK, 34899, Turkey (Türkiye)
NCT Number: NCT07788820
This observational study will compare the clinical outcomes of two cervical interlaminar epidural steroid injection protocols used in routine clinical practice for adults with chronic cervical radicular pain caused by cervical disc herniation. One group received lidocaine, dexamethasone, and normal saline, while the other group received lidocaine, dexamethasone, and magnesium sulfate.
Pain intensity, neck-related disability, and health-related quality of life will be evaluated using the Numeric Rating Scale, Neck Disability Index, and Short Form-12. Outcomes will be assessed before the procedure and at routine follow-up visits up to three months after the procedure.
Treatment selection was based on routine clinical decisions and was not assigned by the researchers. No additional medication, procedure, test, or follow-up visit will be performed for the purposes of this study. The study uses data from existing medical records and routine clinical follow-up assessments.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Observational
Istanbul, PENDİK, 34899, Turkey (Türkiye)
This single-center, comparative retrospective observational cohort study will evaluate adults who underwent cervical interlaminar epidural steroid injection for chronic cervical radicular pain between January 1 and July 1, 2026. Participants will be classified according to the injection protocol received during routine clinical care: lidocaine, dexamethasone, and normal saline, or lidocaine, dexamethasone, and magnesium sulfate. The injection protocol was selected by the treating physician as part of routine clinical practice and was not assigned by the investigators.
Pain intensity will be evaluated using Numeric Rating Scale scores recorded before the procedure and at 1 hour, 3 weeks, and 3 months after the procedure. Neck-related disability and health-related quality of life will be evaluated using Neck Disability Index and Short Form-12 scores recorded before the procedure and at 3 weeks and 3 months.
All study data will be obtained retrospectively from existing electronic medical records, archived patient files, and routine clinical follow-up records. No prospective data collection, study-specific medication, treatment allocation, dose modification, procedure, test, or additional follow-up visit will be performed.
The study aims to determine whether the magnesium sulfate-containing protocol was associated with greater improvement in pain, neck-related disability, and health-related quality of life during the 3-month follow-up period compared with the standard protocol.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Magnesium sulfate was administered as an adjunct to lidocaine and dexamethasone during cervical interlaminar epidural steroid injection as part of routine clinical care. Treatment was not assigned by the investigators.
Normal saline was administered with lidocaine and dexamethasone during cervical interlaminar epidural steroid injection as part of the standard routine clinical protocol. Treatment was not assigned by the investigators.
Time frame: Baseline and 3 months after the procedure
Pain intensity is assessed using the Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The change in pain intensity from baseline to 3 months after the procedure will be compared between the two cohorts. A greater reduction in score indicates greater improvement.
Time frame: Baseline and 1 hour after the procedure
Pain intensity is assessed using the Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The change from baseline to 1 hour after the procedure will be compared between the two cohorts. A greater reduction indicates greater improvement.
Time frame: Baseline and 3 weeks after the procedure
Pain intensity is assessed using the Numeric Rating Scale, ranging from 0 to 10. The change from baseline to 3 weeks after the procedure will be compared between the two cohorts. A greater reduction indicates greater improvement.
Time frame: Baseline, 3 weeks, and 3 months after the procedure
Neck-related disability is assessed using the Neck Disability Index. The total score ranges from 0 to 50, with higher scores indicating greater disability. Changes from baseline will be compared between the two cohorts. A greater reduction indicates greater functional improvement.
Time frame: Baseline, 3 weeks, and 3 months after the procedure
Physical health-related quality of life is assessed using the Physical Component Summary score of the 12-Item Short Form Health Survey. Scores are standardized, with higher scores indicating better physical health-related quality of life. Changes from baseline will be compared between the two cohorts.
Time frame: Baseline, 3 weeks, and 3 months after the procedure
Mental health-related quality of life is assessed using the Mental Component Summary score of the 12-Item Short Form Health Survey. Scores are standardized, with higher scores indicating better mental health-related quality of life. Changes from baseline will be compared between the two cohorts.
Marmara University
Other
Clinical Outcomes of Magnesium Sulfate Use in Cervical Interlaminar Epidural Steroid Injection for Chronic Cervical Radicular Pain: A Comparative Observational Cohort Study
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