Chronic Cervical Radicular PainNCT07776431
Electrophysiological Predictors of Cervical DRG Pulsed Radiofrequency Outcomes
An observational study of Chronic Cervical Radicular Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to determine whether electromyography and nerve conduction study findings can help predict the response to cervical dorsal root ganglion pulsed radiofrequency treatment in patients with chronic cervical radicular pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Cervical Radicular Pain
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 adults aged 18 to 75 years with unilateral chronic cervical radicular pain lasting at least 3 months due to cervical disc herniation and/or spinal stenosis. Eligible participants have persistent symptoms despite conservative treatments and are already scheduled to undergo cervical dorsal root ganglion pulsed radiofrequency treatment as part of routine clinical care. Before treatment, all participants undergo electromyography and nerve conduction studies and are classified according to the presence or absence of electrophysiological evidence of cervical radiculopathy.
Who may be able to join
- Age between 18 and 75 years Presence of cervical disc herniation and/or spinal stenosis Unilateral cervical radicular pain radiating to the arm for at least 3 months, confirmed by clinical evaluation, physical examination, and radiological imaging Inadequate response to conservative treatments, including physical therapy, medical treatment, and/or epidural steroid injection
Who cannot join
- History of cervical spine surgery Presence of myelopathy Predominantly axial neck pain Active infection Vertebral fracture Coagulation disorder Presence of a cardiac pacemaker Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
About this study
Official title: The Role of Electrophysiological Evaluation in Predicting the Success of Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Patients With Chronic Cervical Radicular Pain
This observational study aims to determine whether electromyography and nerve conduction study findings can help predict the response to cervical dorsal root ganglion pulsed radiofrequency treatment in patients with chronic cervical radicular pain. Adults aged 18 to 75 years with unilateral cervical radicular pain who are already scheduled to receive pulsed radiofrequency treatment will undergo an electrophysiological evaluation before the procedure. Participants will be classified according to whether cervical radiculopathy is detected on electrophysiological testing. Pain intensity, neck-related disability, quality of life, and depressive symptoms will be assessed before treatment and at 3 weeks, 3 months, and 6 months after the procedure. Outcomes will be compared between participants with and without electrophysiological evidence of radiculopathy to evaluate whether these findings are associated with treatment success.
- Conditions
- Chronic Cervical Radicular Pain
- Keywords
- Cervical Radicular Pain, Cervical Radiculopathy, Dorsal Root Ganglion, Pulsed Radiofrequency, Electromyography, Nerve Conduction Studies, Electrophysiological Evaluation
- Medical subject headings
- Radiculopathy
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 |
|---|---|---|
| Electrophysiologically Confirmed Radiculopathy | Participants with chronic unilateral cervical radicular pain in whom cervical radiculopathy is detected by baseline electromyography and nerve conduction studies. Participants receive cervical dorsal root ganglion pulsed radiofrequency treatment as part of routine clinical care and are followed for 6 months. | |
| No Electrophysiologically Confirmed Radiculopathy | Participants with chronic unilateral cervical radicular pain in whom cervical radiculopathy is not detected by baseline electromyography and nerve conduction studies. Participants receive cervical dorsal root ganglion pulsed radiofrequency treatment as part of routine clinical care and are followed for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Intensity Assessed by the Numeric Rating Scale
Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. Change from baseline will be calculated at each follow-up visit and compared between participants with and without electrophysiological evidence of cervical radiculopathy. A greater reduction in score indicates greater improvement in pain.
Measured: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Treatment Success Based on the Numeric Rating Scale
Treatment success is defined as a reduction of at least 50% in the Numeric Rating Scale pain score compared with baseline. The proportion of participants achieving treatment success will be compared between participants with and without electrophysiological evidence of cervical radiculopathy.
Measured: 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Secondary outcomes (3)
Change From Baseline in Neck-Related Disability Assessed by the Neck Disability Index
Neck-related disability will be assessed using the Neck Disability Index. Higher scores indicate greater neck-related disability. Change from baseline will be calculated at each follow-up visit and compared between participants with and without electrophysiological evidence of cervical radiculopathy.
Measured: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Change From Baseline in Health-Related Quality of Life Assessed by EuroQol
Health-related quality of life will be assessed using the EuroQol questionnaire. The instrument evaluates mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. It also includes a visual analog scale ranging from 0 to 100, with higher scores indicating better perceived health status. Changes from baseline will be compared between the two electrophysiological groups.
Measured: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory
Depressive symptoms will be assessed using the 21-item Beck Depression Inventory. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. Change from baseline will be calculated at each follow-up visit and compared between participants with and without electrophysiological evidence of cervical radiculopathy.
Measured: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Apr 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cervical Radicular PainStudies 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776431
- Sponsor's protocol ID
- 09.2019.1050
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Electrophysiological Evaluation in Predicting the Success of Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Patients With Chronic Cervical Radicular Pain
- ClinicalTrials.gov ID
- NCT07776431
- Acronym / sponsor ID
- 09.2019.1050
- Conditions
- Chronic Cervical Radicular Pain
- Keywords
- Cervical Radicular Pain, Cervical Radiculopathy, Dorsal Root Ganglion, Pulsed Radiofrequency, Electromyography, Nerve Conduction Studies, Electrophysiological Evaluation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 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 observational study aims to determine whether electromyography and nerve conduction study findings can help predict the response to cervical dorsal root ganglion pulsed radiofrequency treatment in patients with chronic cervical radicular pain. Adults aged 18 to 75 years with unilateral cervical radicular pain who are already scheduled to receive pulsed radiofrequency treatment will undergo an electrophysiological evaluation before the procedure. Participants will be classified according to whether cervical radiculopathy is detected on electrophysiological testing. Pain intensity, neck-related disability, quality of life, and depressive symptoms will be assessed before treatment and at 3 weeks, 3 months, and 6 months after the procedure. Outcomes will be compared between participants with and without electrophysiological evidence of radiculopathy to evaluate whether these findings are associated with treatment success.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrophysiologically Confirmed Radiculopathy | – | –Participants with chronic unilateral cervical radicular pain in whom cervical radiculopathy is detected by baseline electromyography and nerve conduction studies. Participants receive cervical dorsal root ganglion pulsed radiofrequency treatment as part of routine clinical care and are followed for 6 months. |
| No Electrophysiologically Confirmed Radiculopathy | – | –Participants with chronic unilateral cervical radicular pain in whom cervical radiculopathy is not detected by baseline electromyography and nerve conduction studies. Participants receive cervical dorsal root ganglion pulsed radiofrequency treatment as part of routine clinical care and are followed for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults aged 18 to 75 years with unilateral chronic cervical radicular pain lasting at least 3 months due to cervical disc herniation and/or spinal stenosis. Eligible participants have persistent symptoms despite conservative treatments and are already scheduled to undergo cervical dorsal root ganglion pulsed radiofrequency treatment as part of routine clinical care. Before treatment, all participants undergo electromyography and nerve conduction studies and are classified according to the presence or absence of electrophysiological evidence of cervical radiculopathy.
Key inclusion criteria (1 listed)
- Age between 18 and 75 years Presence of cervical disc herniation and/or spinal stenosis Unilateral cervical radicular pain radiating to the arm for at least 3 months, confirmed by clinical evaluation, physical examination, and radiological imaging Inadequate response to conservative treatments, including physical therapy, medical treatment, and/or epidural steroid injection
Key exclusion criteria (1 listed)
- History of cervical spine surgery Presence of myelopathy Predominantly axial neck pain Active infection Vertebral fracture Coagulation disorder Presence of a cardiac pacemaker Refusal or inability to provide informed consent
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
Change From Baseline in Pain Intensity Assessed by the Numeric Rating Scale
Time frame: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. Change from baseline will be calculated at each follow-up visit and compared between participants with and without electrophysiological evidence of cervical radiculopathy. A greater reduction in score indicates greater improvement in pain.
Treatment Success Based on the Numeric Rating Scale
Time frame: 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Treatment success is defined as a reduction of at least 50% in the Numeric Rating Scale pain score compared with baseline. The proportion of participants achieving treatment success will be compared between participants with and without electrophysiological evidence of cervical radiculopathy.
3 secondary outcomes
Change From Baseline in Neck-Related Disability Assessed by the Neck Disability Index
Time frame: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Change From Baseline in Health-Related Quality of Life Assessed by EuroQol
Time frame: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory
Time frame: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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 Chronic Cervical Radicular Pain, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 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?
This study is still under way. Results are not available in the source record yet.
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 From Baseline in Pain Intensity Assessed by the Numeric Rating Scale (time frame: Baseline, 3 weeks, 3 months, and 6 months after cervical dorsal root ganglion pulsed radiofrequency treatment). The study lists 2 primary outcomes in all. 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 20 Aug 2026.