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).
Trial 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. Read more about this study
- 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
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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.
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
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 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.
- 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 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 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.
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.
- First posted27 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Oct 2026
- Study completion15 Oct 2026
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.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haner Direskeneli, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788820
- Sponsor's protocol ID
- 09.2026.26-0640
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Magnesium Sulfate Use in Cervical Interlaminar Epidural Steroid Injection for Chronic Cervical Radicular Pain: A Comparative Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07788820
- Acronym / sponsor ID
- 09.2026.26-0640
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Protocol | – | Drug: Normal SalineParticipants who received a cervical interlaminar epidural steroid injection containing lidocaine, dexamethasone, and normal saline as part of routine clinical care. |
| Magnesium Sulfate Protocol | – | Drug: Magnesium SulfateParticipants who received a cervical interlaminar epidural steroid injection containing lidocaine, dexamethasone, and magnesium sulfate as part of routine clinical care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateMagnesium 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. | Drug | Magnesium Sulfate Protocol |
| Normal SalineNormal 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. | Drug | Standard Treatment Protocol |
Primary outcome
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.
5 secondary outcomes
Early Change in Pain Intensity
Time frame: Baseline and 1 hour after the procedure
Change in Pain Intensity at 3 Weeks
Time frame: Baseline and 3 weeks after the procedure
Change in Neck-Related Disability
Time frame: Baseline, 3 weeks, and 3 months after the procedure
Change in SF-12 Physical Component Summary Score
Time frame: Baseline, 3 weeks, and 3 months after the procedure
Change in SF-12 Mental Component Summary Score
Time frame: Baseline, 3 weeks, and 3 months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Radiculopathy and Cervical Disc Herniation, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity From Baseline to 3 Months (time frame: Baseline and 3 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.