Radiculopathy, Cervical RegionM-DICERNCT07535476
Predictors of Clinical Response After Interlaminar Cervical Epidural Steroid Injection for Cervical Radiculopathy
An observational study of Radiculopathy, Cervical Region and Neck Pain, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Cervical epidural steroid injection is a commonly used treatment option for patients with cervical radicular pain who do not improve adequately with conservative treatment. Cervical radicular pain typically radiates from the neck to the shoulder, arm, or hand and may be accompanied by numbness, weakness or changes in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy, Cervical Region, Neck Pain, Disc Disease
- Type of treatment
- Injection or infusion
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 10 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients with cervical radiculopathy related to cervical disc herniation who underwent interlaminar cervical epidural steroid injection at the Mersin University Faculty of Medicine, Pain Clinic between January 1, 2018, and October 1, 2025. Only patients who met the predefined inclusion and exclusion criteria and had available pre-procedural, procedural, and post-procedural follow-up data, including Numeric Rating Scale (NRS-11) pain scores, were included in the analysis.
Who may be able to join
- Age ≥ 18 years.
- Presence of neck and upper extremity pain consistent with cervical radiculopathy
- Persistence of symptoms for at least 1 month despite conservative treatment
- Documented baseline NRS-11 pain score prior to the procedure and follow-up NRS-11 data available through at least 6 months after treatment.
Who cannot join
- Active infection during the time of injection
- Allergie to local anesthetics or contrast agents
- History of bleeding diathesis.
- Insufficient follow-up data (less than 6 months of follow-up NRS-11 documentation).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Pain Medicine, Mersin University Faculty of Medicine
Mersin, Ciftlikkoy, 33110
About this study
Official title: Predictors of Clinical Response After Interlaminar Cervical Epidural Steroid Injection for Cervical Radiculopathy: A Retrospective Cohort Study
Cervical epidural steroid injection is a commonly used treatment option for patients with cervical radicular pain who do not improve adequately with conservative treatment. Cervical radicular pain typically radiates from the neck to the shoulder, arm, or hand and may be accompanied by numbness, weakness or changes in reflexes. The most common causes are cervical disc herniation and cervical spondylosis. By reducing inflammation around the affected nerve root, epidural steroid injection may help relieve pain and improve function. Among available techniques, the interlaminar approach is frequently preferred in the cervical region because of its technical feasibility and safety profile.
Although interlaminar cervical epidural steroid injection is widely used, treatment response varies among patients, and not all individuals experience the same degree of benefit. Identifying the factors associated with better or poorer clinical response may help improve patient selection and reduce unnecessary procedures.
This retrospective cohort study aims to evaluate clinical outcomes after interlaminar cervical epidural steroid injection in patients with cervical radiculopathy and to investigate demographic, clinical, and procedure-related variables which may predict treatment response. By analyzing pain scores before and after the procedure, this study seeks to better define the predictors of clinical outcome following this intervention.
Read the detailed description
This retrospective cohort study will review the medical records of patients who presented to the Pain Clinic of Mersin University Faculty of Medicine Hospital between January 1, 2018, and October 1, 2025, with neck pain related to cervical disc herniation and underwent interlaminar cervical epidural steroid injection.
The study population will consist of adult patients who were diagnosed and/or followed by physicians in the research team, had neck pain associated with cervical disc herniation for at least 1 month and provided written informed consent for the procedure. Patients will be excluded if they had an active infection at the time of injection, a history of allergy to local anesthetic or contrast agents or a bleeding diathesis.
Data will be collected from existing medical records using a standardized data collection form. Variables of interest will include age, sex, duration of pain, clinical diagnosis, type of corticosteroid used, presence of fibromyalgia, use of transcutaneous electrical nerve stimulation (TENS), history of trigger point injection, electromyography findings and Numeric Rating Scale (NRS-11) pain scores recorded before the procedure and at 1-month and 6-month follow-up.
The primary aim of the study is to identify demographic, clinical, and procedure-related factors associated with clinical response after interlaminar cervical epidural steroid injection in patients with cervical radiculopathy related to cervical disc herniation.
- Keywords
- Interventional Pain Management, Treatment Outcome, Injections, Spinal, Injection, Epidural
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Cervical Interlaminar Epidural Steroid Injection | This cohort includes eligible patients with cervical radiculopathy due to cervical disc herniation who received interlaminar cervical epidural steroid injection during the study period. In patients who received more than one procedure, only the first injection was analyzed. Clinical response was evaluated retrospectively based on pain scores documented before the procedure and during follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response at 6 months (IMMPACT-defined responder rate)
Responder defined as ≥50% reduction or ≥4-point decrease in NRS-11 compared with baseline.
Measured: 6 months
Secondary outcomes (1)
Change in NRS-11 pain score from baseline
NRS-11 ranges from 0 (no pain) to 10 (worst imaginable pain).
Measured: Baseline, 1 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jan 2018
- Primary completion1 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radiculopathy, Cervical RegionStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Bakır, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535476
- Sponsor's protocol ID
- MERSINALG-CESI -2026
- Acronym
- M-DICER
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available because the study is based on retrospectively collected medical record data from a single center, and sharing such data may raise confidentiality and privacy concerns.
Publications
Yolcu G, Toprak CS, Sencan S, Gunduz OH. Dry Needling Plus Cervical Interlaminar Epidural Steroid Injections: Do We Have More Favorable Results in Cervical Disc Herniation? A Randomized Sham-Controlled Clinical Study. Am J Phys Med Rehabil. 2024 Dec 1;103(12):1081-1087. doi: 10.1097/PHM.0000000000002509.
PubMed 39671525Yildiz G, Perdecioglu GRG, Akkaya OT, Can E, Yuruk D. Comparison of Selective Nerve Root Pulsed Radiofrequency Vs Paramedian Interlaminar Epidural Steroid Injection for the Treatment of Painful Cervical Radiculopathy. Pain Physician. 2024 Feb;27(2):E221-E229.
PubMed 38324787Sacaklidir R, Sanal-Toprak C, Yucel FN, Gunduz OH, Sencan S. The Effect of Central Sensitization on Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients with Cervical Disc Herniation: An Observational Study. Pain Physician. 2022 Sep;25(6):E823-E829.
PubMed 36122265
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Clinical Response After Interlaminar Cervical Epidural Steroid Injection for Cervical Radiculopathy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07535476
- Acronym / sponsor ID
- M-DICER / MERSINALG-CESI -2026
- Keywords
- Interventional Pain Management, Treatment Outcome, Injections, Spinal, Injection, Epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 17 Apr 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.
Cervical epidural steroid injection is a commonly used treatment option for patients with cervical radicular pain who do not improve adequately with conservative treatment. Cervical radicular pain typically radiates from the neck to the shoulder, arm, or hand and may be accompanied by numbness, weakness or changes in reflexes. The most common causes are cervical disc herniation and cervical spondylosis. By reducing inflammation around the affected nerve root, epidural steroid injection may help relieve pain and improve function. Among available techniques, the interlaminar approach is frequently preferred in the cervical region because of its technical feasibility and safety profile.
Although interlaminar cervical epidural steroid injection is widely used, treatment response varies among patients, and not all individuals experience the same degree of benefit. Identifying the factors associated with better or poorer clinical response may help improve patient selection and reduce unnecessary procedures.
This retrospective cohort study aims to evaluate clinical outcomes after interlaminar cervical epidural steroid injection in patients with cervical radiculopathy and to investigate demographic, clinical, and procedure-related variables which may predict treatment response. By analyzing pain scores before and after the procedure, this study seeks to better define the predictors of clinical outcome following this intervention.
Detailed description
This retrospective cohort study will review the medical records of patients who presented to the Pain Clinic of Mersin University Faculty of Medicine Hospital between January 1, 2018, and October 1, 2025, with neck pain related to cervical disc herniation and underwent interlaminar cervical epidural steroid injection.
The study population will consist of adult patients who were diagnosed and/or followed by physicians in the research team, had neck pain associated with cervical disc herniation for at least 1 month and provided written informed consent for the procedure. Patients will be excluded if they had an active infection at the time of injection, a history of allergy to local anesthetic or contrast agents or a bleeding diathesis.
Data will be collected from existing medical records using a standardized data collection form. Variables of interest will include age, sex, duration of pain, clinical diagnosis, type of corticosteroid used, presence of fibromyalgia, use of transcutaneous electrical nerve stimulation (TENS), history of trigger point injection, electromyography findings and Numeric Rating Scale (NRS-11) pain scores recorded before the procedure and at 1-month and 6-month follow-up.
The primary aim of the study is to identify demographic, clinical, and procedure-related factors associated with clinical response after interlaminar cervical epidural steroid injection in patients with cervical radiculopathy related to cervical disc herniation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Cervical Interlaminar Epidural Steroid Injection | – | –This cohort includes eligible patients with cervical radiculopathy due to cervical disc herniation who received interlaminar cervical epidural steroid injection during the study period. In patients who received more than one procedure, only the first injection was analyzed. Clinical response was evaluated retrospectively based on pain scores documented before the procedure and during follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with cervical radiculopathy related to cervical disc herniation who underwent interlaminar cervical epidural steroid injection at the Mersin University Faculty of Medicine, Pain Clinic between January 1, 2018, and October 1, 2025. Only patients who met the predefined inclusion and exclusion criteria and had available pre-procedural, procedural, and post-procedural follow-up data, including Numeric Rating Scale (NRS-11) pain scores, were included in the analysis.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Presence of neck and upper extremity pain consistent with cervical radiculopathy
- Persistence of symptoms for at least 1 month despite conservative treatment
- Documented baseline NRS-11 pain score prior to the procedure and follow-up NRS-11 data available through at least 6 months after treatment.
Key exclusion criteria (4 listed)
- Active infection during the time of injection
- Allergie to local anesthetics or contrast agents
- History of bleeding diathesis.
- Insufficient follow-up data (less than 6 months of follow-up NRS-11 documentation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment response at 6 months (IMMPACT-defined responder rate)
Time frame: 6 months
Responder defined as ≥50% reduction or ≥4-point decrease in NRS-11 compared with baseline.
1 secondary outcome
Change in NRS-11 pain score from baseline
Time frame: Baseline, 1 months, and 6 months
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 17 Apr 2026.
- Background: PubMed 39671525Yolcu G, Toprak CS, Sencan S, Gunduz OH. Dry Needling Plus Cervical Interlaminar Epidural Steroid Injections: Do We Have More Favorable Results in Cervical Disc Herniation? A Randomized Sham-Controlled Clinical Study. Am J Phys Med Rehabil. 2024 Dec 1;103(12):1081-1087. doi: 10.1097/PHM.0000000000002509.
- Background: PubMed 38324787Yildiz G, Perdecioglu GRG, Akkaya OT, Can E, Yuruk D. Comparison of Selective Nerve Root Pulsed Radiofrequency Vs Paramedian Interlaminar Epidural Steroid Injection for the Treatment of Painful Cervical Radiculopathy. Pain Physician. 2024 Feb;27(2):E221-E229.
- Background: PubMed 36122265Sacaklidir R, Sanal-Toprak C, Yucel FN, Gunduz OH, Sencan S. The Effect of Central Sensitization on Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients with Cervical Disc Herniation: An Observational Study. Pain Physician. 2022 Sep;25(6):E823-E829.
- Individual participant dataSharing planned: No. Individual participant data will not be made available because the study is based on retrospectively collected medical record data from a single center, and sharing such data may raise confidentiality and privacy concerns.
Related trials for Radiculopathy, Cervical Region
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
RecruitingPhase 4
Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
Back Pain Lower Back, Neck Pain
Recruiting
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
Neck Pain, Spondylosis
Recruiting
Cervical Arthroplasty Cost Effectiveness Study (CACES)
Radiculopathy, Cervical, Myelopathy Cervical
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 Radiculopathy, Cervical Region and Neck Pain, run by Mersin 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 4 inclusion and 4 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 17 Apr 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?
Treatment response at 6 months (IMMPACT-defined responder rate) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535476, which also lists 3 linked publications.
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 17 Apr 2026.