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Active, not recruiting

NCT Number: NCT07788820

Clinical Outcomes of Magnesium Sulfate in Cervical Interlaminar Epidural Steroid Injection

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Faculty of Medicine

Istanbul, PENDİK, 34899, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 75 years
  • Diagnosis of cervical disc herniation associated with chronic cervical radicular pain
  • Underwent cervical interlaminar epidural steroid injection
  • Availability of pre-procedure and 1-hour post-procedure Numeric Rating Scale scores
  • Availability of baseline and 3-week Neck Disability Index and Short Form-12 assessments
  • Availability of the 3-month routine follow-up assessment
  • Documented injection protocol: standard protocol or magnesium sulfate-containing protocol

Exclusion criteria

  • Cervical pain primarily attributable to a condition other than cervical radiculopathy
  • Previous cervical spine surgery
  • Cervical pain associated with malignancy, infection, trauma, or inflammatory disease
  • Advanced neurological deficit or clinical findings of myelopathy
  • Receipt of another interventional pain procedure during the same follow-up period
  • Missing pre-procedure or 1-hour post-procedure Numeric Rating Scale data
  • Missing baseline, 3-week, or 3-month Neck Disability Index or Short Form-12 data
  • Unavailable or inadequately documented injection content or treatment protocol

Treatment and study plan

Magnesium sulfate

Drug

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

Drug

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.

Primary outcomes

  1. Change in Pain Intensity From Baseline to 3 Months

    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.

Secondary outcomes

  1. Early Change in Pain Intensity

    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.

  2. Change in Pain Intensity at 3 Weeks

    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.

  3. Change in Neck-Related Disability

    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.

  4. Change in SF-12 Physical Component Summary Score

    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.

  5. Change in SF-12 Mental Component Summary Score

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Clinical Outcomes of Magnesium Sulfate Use in Cervical Interlaminar Epidural Steroid Injection for Chronic Cervical Radicular Pain: A Comparative Observational Cohort Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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