Cervical Disc Herniation, Cervical Radiculopathy
Conditions
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
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.
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.
Interventions
DRUGMagnesium Sulfate
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.
DRUGNormal Saline
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.
Sponsors
Marmara University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity From Baseline to 3 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Early Change in Pain Intensity | 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. |
| Change in Pain Intensity at 3 Weeks | 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. |
| Change in Neck-Related Disability | 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. |
| Change in SF-12 Physical Component Summary Score | 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. |
| Change in SF-12 Mental Component Summary Score | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed