ClinicalTrials.gg
CompletedNCT07788820Updated Oct 30, 2026

Clinical Outcomes of Magnesium Sulfate in Cervical Interlaminar Epidural Steroid Injection

An observational study in Cervical Radiculopathy and Cervical Disc Herniation, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Marmara University · Observational

Updated Oct 30, 2026Now CompletedStudy completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
123
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Radiculopathy by Marmara University — 8 open to participants now, 10 under way, none of them phase 3. Radiculopathy · Marmara University.

Enrollment
5th of 12
123 · median 120
Started
2026
with 4 others
Observational
12 of 18
7 open now
Registered
16th of 18
by date

Among the 18 studies in Radiculopathy by Marmara University, this one is the 5th largest by enrollment of the 12 observational ones, is one of 5 that started in 2026, is one of 12 observational ones, and was the 16th registered.

By phase

18 studies; the count open now beside each. This study's row is marked.

Observationalthis study12 · 7 open
No phase6 · 1 open

By the year they started

First in 2016; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 61 across the 6 interventional studies, 120 across the 12 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 18 studies in Radiculopathy by Marmara University, or all of them as a file.
02

Study summary

This single-center observational comparative cohort study evaluates clinical outcomes following two cervical interlaminar epidural steroid injection protocols used in routine care for chronic cervical radicular pain due to cervical disc herniation. Patients underwent the procedure between January 1 and July 1, 2026 and were classified according to the injectate already administered: lidocaine, dexamethasone, and normal saline, or lidocaine, dexamethasone, and magnesium sulfate. Treatment selection was determined by the treating physician during routine clinical care and was not assigned by the investigators. Data available at ethics approval were obtained retrospectively from clinical records. For patients whose scheduled routine follow-up had not yet occurred, follow-up outcomes were recorded prospectively after ethics approval. No research-specific treatment, additional visit, additional test, or modification of routine care was undertaken. Pain, neck-related disability, and health-related quality of life were evaluated using the Numeric Rating Scale, Neck Disability Index, and Short Form-12 over three months.

Read the detailed description

Eligible adults aged 18 to 75 years who underwent cervical interlaminar epidural steroid injection for chronic cervical radicular pain associated with cervical disc herniation between January 1 and July 1, 2026 were included in this single-center observational comparative cohort. Patients were classified according to the treatment received in routine clinical care. Both protocols contained lidocaine and dexamethasone; the magnesium sulfate protocol replaced the normal saline component with magnesium sulfate. The procedure and injectate were selected before study-specific prospective follow-up, based on the treating physician's clinical decision. They were not assigned or modified by the investigators.

The study combines retrospective review of existing records and prospective recording of remaining routine follow-up assessments after ethics approval. No additional intervention, assessment, test, medication, or follow-up visit was introduced for the study. Numeric Rating Scale scores were assessed before the procedure and at 1 hour, 3 weeks, and 3 months. Neck Disability Index and Short Form-12 physical and mental component scores were assessed at baseline, 3 weeks, and 3 months. The registered primary outcome remains change in Numeric Rating Scale score from baseline to 3 months. Other pain time points and changes in neck-related disability and quality of life remain secondary outcomes. The study evaluates associations between the protocol received and clinical outcomes; treatment allocation was not randomized.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults aged 18 to 75 years 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. Eligible patients with the required baseline and routine follow-up data form the comparative cohort. Existing data were reviewed retrospectively, and routine follow-up assessments not yet completed at ethics approval were recorded prospectively thereafter.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 to 75 years
  • Diagnosis of cervical disc herniation associated with chronic cervical radicular pain
  • Underwent cervical interlaminar epidural 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

Exclusion Criteria:

  • Cervical pain primarily attributable to a condition other than cervical radiculopathy
  • Previous cervical spine surgery
  • Cervical pain associated with , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
123 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 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.

06

What researchers measure

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.

    Time frame: Baseline and 3 months after the procedure

Secondary outcomes

  1. 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.

    Time frame: Baseline and 1 hour after the procedure

  2. 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.

    Time frame: Baseline and 3 weeks after the procedure

  3. Change in Neck-Related Disability

    Neck-related disability is assessed using the 10-item Neck Disability Index. Raw item scores total 0 to 50 and can be expressed on a 0 to 100 scale by multiplying by two. For analysis, both cohorts are harmonized to the 0 to 100 scale, with higher scores indicating greater disability. Changes from baseline at 3 weeks and 3 months are compared between cohorts.

    Time frame: Baseline, 3 weeks, and 3 months after the procedure

  4. 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.

    Time frame: Baseline, 3 weeks, and 3 months after the procedure

  5. 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.

    Time frame: Baseline, 3 weeks, and 3 months after the procedure

07

Study locations

1 site
  • Marmara University Faculty of Medicine
    Istanbul, PENDİK 34899, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Oct 2026, 9 months.

Of 40 observational studies under Radiculopathy, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 95. This study's 9 months is below that.

Completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Oct 2026, on Oct 30, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2026
First posted
Aug 27, 2026
StartActual
Jan 1, 2026
Primary completionActual
Oct 1, 2026
CompletionActual
Oct 15, 2026was Dec 2026
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Oct 30, 2026
Study completion
Dec 2026→Oct 15, 2026 (actual)
Oct 30, 2026
Enrollment
120 (estimated)→123 (actual)
Oct 30, 2026
Eligibility
Revised
Oct 30, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionChange in Neck-Related Disability: how it is measured was reworded
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Active, not recruiting→Completed
    Study completion Dec 2026→Oct 15, 2026 (now actual)
    Enrollment 120 (estimated)→123 (actual)
    Eligibility Revised
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange in Neck-Related Disability: how it is measured was reworded
    + 3 other changes: verification date, description and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07788820
Lead sponsor
Marmara University
Responsible party
Haner Direskeneli (Professor, MD, Marmara University) — Principal investigator
First posted
Aug 27, 2026
Start date
Jan 1, 2026
Primary completion
Oct 1, 2026
Completion
Oct 15, 2026
Last update
Oct 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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