Cervical RadiculopathyNCT07788820

Clinical Outcomes of Magnesium Sulfate in Cervical Interlaminar Epidural Steroid Injection

An observational study of Cervical Radiculopathy and Cervical Disc Herniation, run by Marmara University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Cervical Radiculopathy, Cervical Disc Herniation
What is being tested?: Magnesium Sulfate and Normal Saline
Type of treatment: Injection or infusion
How many people: 120 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2026to Dec 2026
Phase: Observational

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Marmara University Faculty of Medicine
Istanbul, PENDİK, 34899

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

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.

Conditions: Cervical Radiculopathy, Cervical Disc Herniation
Being tested: Magnesium Sulfate, Normal Saline
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
Medical subject headings: Radiculopathy, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnesium SulfateDrug
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 SalineDrug
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.

Study groups in NCT07788820
Study group	Role	What they receive
Standard Treatment Protocol		Participants who received a cervical interlaminar epidural steroid injection containing lidocaine, dexamethasone, and normal saline as part of routine clinical care. Receives: 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. Receives: Drug: Magnesium Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 3 months after the procedure

Secondary outcomes (5)

Early Change in Pain Intensity
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.
Measured: Baseline and 1 hour after the procedure
Change in Pain Intensity at 3 Weeks
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.
Measured: Baseline and 3 weeks after the procedure
Change in Neck-Related Disability
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.
Measured: Baseline, 3 weeks, and 3 months after the procedure
Change in SF-12 Physical Component Summary Score
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.
Measured: Baseline, 3 weeks, and 3 months after the procedure
Change in SF-12 Mental Component Summary Score
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.
Measured: Baseline, 3 weeks, and 3 months after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 2026Dec 2026

First posted27 Aug 2026
Study start1 Jan 2026
Primary completionOct 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical RadiculopathyStudies 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: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07788820
Sponsor's protocol ID: 09.2026.26-0640
Status last verified: Aug 2026
First submitted: 22 Aug 2026
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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