Clinical Outcomes of Magnesium Sulfate in Cervical Interlaminar Epidural Steroid Injection

NCT07788820 | Active Not Recruiting

• 1 other identifier: 09.2026.26-0640
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Radiculopathy; Cervical Disc Herniation

Keywords

Chronic Cervical Radicular Pain; Cervical Interlaminar Epidural Steroid Injection; Magnesium Sulfate; Epidural Steroid Injection; Cervical Disc Herniation; Neck Disability; Neuropathic Pain; Numeric Rating Scale; Health-Related Quality of Life; neck disability index

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity From Baseline to 3 Months

  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.

  Baseline and 3 months after the procedure

Secondary Outcomes (5)

• Early Change in Pain Intensity

  Baseline and 1 hour after the procedure

• Change in Pain Intensity at 3 Weeks

  Baseline and 3 weeks after the procedure

• Change in Neck-Related Disability

  Baseline, 3 weeks, and 3 months after the procedure

• Change in SF-12 Physical Component Summary Score

  Baseline, 3 weeks, and 3 months after the procedure

• Change in SF-12 Mental Component Summary Score

  Baseline, 3 weeks, and 3 months after the procedure

Study Arms (2)

Standard Treatment Protocol

Participants who received a cervical interlaminar epidural steroid injection containing lidocaine, dexamethasone, and normal saline as part of routine clinical care.

Drug: Normal Saline

Magnesium Sulfate Protocol

Participants who received a cervical interlaminar epidural steroid injection containing lidocaine, dexamethasone, and magnesium sulfate as part of routine clinical care.

Drug: Magnesium Sulfate

Interventions

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.

Magnesium Sulfate Protocol

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.

Standard Treatment Protocol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients who underwent cervical interlaminar epidural steroid injection for chronic cervical radicular pain associated with cervical disc herniation at the Pain Medicine Division of Marmara University Pendik Training and Research Hospital between January 1 and July 1, 2026. All patients meeting the eligibility criteria and having complete routine clinical follow-up records will be included in the retrospective cohort.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Medicine

Istanbul, PENDİK, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy; Neuralgia

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)