Transforaminal Epidural InjectionNCT07397286
The Effect of Adding a Local Anesthetic to Transforaminal Epidural Injection in Cervical Disc Herniation.
A study testing servical transforaminal epidural steroid injection with local anaesthetic and servical transforaminal epidural steroid injection without local anaesthetic in people with Transforaminal Epidural Injection and Dorsal Root Ganglion Stimulation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The study is designed as a double-blind, prospective, randomized controlled trial. Blindness is ensured by having different researchers performing the interventional procedures and monitoring the pain diaries, thus preventing them from knowing which procedure is performed on which patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transforaminal Epidural Injection, Dorsal Root Ganglion Stimulation, Servical Disc Herniation
- What is being tested?
- servical transforaminal epidural steroid injection with local anaesthetic and servical transforaminal epidural steroid injection without local anaesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2025to May 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients consisted of those who presented to our outpatient clinic with neck and arm pain, who had received medical and/or physical therapy but whose symptoms did not improve.
Who cannot join
- The procedure was not performed on those with neurological deficits requiring surgery, those with known allergies to lidocaine and dexamethasone, those who had recently undergone head and neck surgery, diabetic patients with impaired blood sugar regulation, those who had received epidural steroid injections or depot steroids within the last 15 days, those with progressive neurological deficits, those with coagulation disorders (INR > 1.5; platelets < 100,000/mm³), those with any lesion or infection in the cervical region that would prevent epidural intervention, and pregnant women.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Efeler / Aydın
Aydin, 09100
About this study
Official title: Comparison of the Efficacy of Combined Dorsal Root Ganglion Pulsed Radiofrequency and Cervical Transforaminal Epidural Steroid Injection With and Without Local Anesthetic in Cervical Disc Herniation, Prospective Controlled Study
The study is designed as a double-blind, prospective, randomized controlled trial. Blindness is ensured by having different researchers performing the interventional procedures and monitoring the pain diaries, thus preventing them from knowing which procedure is performed on which patient. Patient randomization will be performed using computer assistance.
After obtaining approval from the hospital ethics committee, clinical trials will be initiated. Patients who present to the Department of Neurology, Algology Division, ADÜTF between 2025-2026 and undergo DRG-PRF and TFAESI for radicular pain due to cervical disc herniation will be divided into two groups. Patients in Group 1 will undergo DRG-PRF and TFAESI with the addition of local anesthetic. Patients in Group 2 will undergo DRG-PRF and TFAESI without the addition of local anesthetic. During the study, NRS score measurements will be taken to assess pain intensity in patients in both Group 1 and Group 2 before the procedure and at 1, 3, and 6 months post-procedure follow-ups. Neurological and musculoskeletal examinations will be performed during routine check-ups before the procedure and at 1, 3, and 6 months after the procedure, and any developing side effects will be recorded.
Read the detailed description
The interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device. The first intervertebral foramen visible under fluoroscopy is C2-C3. Once the appropriate cervical space is identified, the C-arm fluoroscopy device is directed obliquely to 45-65 degrees until the cervical neural foramen is visualized as a circle. The cannula insertion site is determined. The skin and subcutaneous tissue are anesthetized with 2% lidocaine. A 5 cm long RF cannula with a 5 mm active tip is advanced towards the 6 o'clock position of the neural foramina. The needle is advanced until it contacts the superior facet joint, then guided into the foramen. After entering the foramen, to avoid direct intrathecal or spinal cord damage, the needle is advanced to the facet column and into the epidural space while anteroposterior views are obtained with fluoroscopy. Approximately 0.5 mL of non-ionizing contrast agent is injected to confirm needle placement. The spread of radiopaque material, which adheres to the periradicular membrane, is observed both within the foramen and around the nerve root during fluoroscopy. If abnormal sensation, vibration, or pain is observed with a stimulus less than 0.7 Volts for sensory stimulation, or if a pulse is felt in the arm with a stimulus less than 2.0 Volts for motor stimulation, it is assumed that the catheter needle has been placed near the dorsal root ganglion. Subsequently, patients in Group 1 are given 4 mg dexamethasone + 20 mg lidocaine, and patients in Group 2 are given 4 mg dexamethasone. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC, and it is subjected to pulsed radiofrequency treatment for 4 minutes. Patient response will be determined based on the reduction in pain at follow-up examinations at 1, 3, and 6 months after the procedure as follows: good response > 50% reduction, poor response < 50% reduction, or no change, no response.
- Conditions
- Transforaminal Epidural Injection, Dorsal Root Ganglion Stimulation, Servical Disc Herniation
- Being tested
- servical transforaminal epidural steroid injection with local anaesthetic, servical transforaminal epidural steroid injection without local anaesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
servical transforaminal epidural steroid injection with local anaestheticProcedure or surgery
The interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device.Subsequently, patients in Group 1 receive 4 mg dexamethasone and 1cc lidocain. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC.
servical transforaminal epidural steroid injection without local anaestheticProcedure or surgery
The interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device.Subsequently, patients in Group 2 receive 4 mg dexamethasone. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC.
| Study group | Role | What they receive |
|---|---|---|
| patients to whom applied epidural injection with local anaesthetic | Experimental | Patients in Group 1 are given 4 mg of dexamethasone + 20 mg of lidocaine. The radiofrequency generator is adjusted so that the catheter needle tip temperature does not exceed 42 ºC, and they undergo pulsed radiofrequency treatment for 4 minutes Receives: Procedure: servical transforaminal epidural steroid injection with local anaesthetic |
| patients to whom applied epidural injection without local anaesthetic | Active comparator | Patients in Group 2 are given 4 mg of dexamethasone. The radiofrequency generator is adjusted so that the catheter needle tip temperature does not exceed 42 ºC, and they undergo pulsed radiofrequency treatment for 4 minutes. Receives: Procedure: servical transforaminal epidural steroid injection without local anaesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare whether the addition of a local anesthetic to combined DRG-pulsed RF and transforaminal anterior epidural steroid injection (TAESI) treatment makes a difference in clinical efficacy in patients with cervical disc herniation
In patients with radicular neck pain due to cervical disc herniation, the clinical efficacy of adding a local anesthetic during combined DRG-pulsed RF and transforaminal anterior epidural steroid injection (TAESI) was evaluated using the NRS (Numerical Rating Scale) to assess pain control.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start19 Nov 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transforaminal Epidural InjectionStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ertilav, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397286
- Sponsor's protocol ID
- 2025/297
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Combined Dorsal Root Ganglion Pulsed Radiofrequency and Cervical Transforaminal Epidural Steroid Injection With and Without Local Anesthetic in Cervical Disc Herniation, Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT07397286
- Acronym / sponsor ID
- 2025/297
- Conditions
- Transforaminal Epidural Injection, Dorsal Root Ganglion Stimulation, Servical Disc Herniation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Feb 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.
The study is designed as a double-blind, prospective, randomized controlled trial. Blindness is ensured by having different researchers performing the interventional procedures and monitoring the pain diaries, thus preventing them from knowing which procedure is performed on which patient. Patient randomization will be performed using computer assistance.
After obtaining approval from the hospital ethics committee, clinical trials will be initiated. Patients who present to the Department of Neurology, Algology Division, ADÜTF between 2025-2026 and undergo DRG-PRF and TFAESI for radicular pain due to cervical disc herniation will be divided into two groups. Patients in Group 1 will undergo DRG-PRF and TFAESI with the addition of local anesthetic. Patients in Group 2 will undergo DRG-PRF and TFAESI without the addition of local anesthetic. During the study, NRS score measurements will be taken to assess pain intensity in patients in both Group 1 and Group 2 before the procedure and at 1, 3, and 6 months post-procedure follow-ups. Neurological and musculoskeletal examinations will be performed during routine check-ups before the procedure and at 1, 3, and 6 months after the procedure, and any developing side effects will be recorded.
Detailed description
The interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device. The first intervertebral foramen visible under fluoroscopy is C2-C3. Once the appropriate cervical space is identified, the C-arm fluoroscopy device is directed obliquely to 45-65 degrees until the cervical neural foramen is visualized as a circle. The cannula insertion site is determined. The skin and subcutaneous tissue are anesthetized with 2% lidocaine. A 5 cm long RF cannula with a 5 mm active tip is advanced towards the 6 o'clock position of the neural foramina. The needle is advanced until it contacts the superior facet joint, then guided into the foramen. After entering the foramen, to avoid direct intrathecal or spinal cord damage, the needle is advanced to the facet column and into the epidural space while anteroposterior views are obtained with fluoroscopy. Approximately 0.5 mL of non-ionizing contrast agent is injected to confirm needle placement. The spread of radiopaque material, which adheres to the periradicular membrane, is observed both within the foramen and around the nerve root during fluoroscopy. If abnormal sensation, vibration, or pain is observed with a stimulus less than 0.7 Volts for sensory stimulation, or if a pulse is felt in the arm with a stimulus less than 2.0 Volts for motor stimulation, it is assumed that the catheter needle has been placed near the dorsal root ganglion. Subsequently, patients in Group 1 are given 4 mg dexamethasone + 20 mg lidocaine, and patients in Group 2 are given 4 mg dexamethasone. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC, and it is subjected to pulsed radiofrequency treatment for 4 minutes. Patient response will be determined based on the reduction in pain at follow-up examinations at 1, 3, and 6 months after the procedure as follows: good response > 50% reduction, poor response < 50% reduction, or no change, no response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients to whom applied epidural injection with local anaesthetic | Experimental | Procedure: servical transforaminal epidural steroid injection with local anaestheticPatients in Group 1 are given 4 mg of dexamethasone + 20 mg of lidocaine. The radiofrequency generator is adjusted so that the catheter needle tip temperature does not exceed 42 ºC, and they undergo pulsed radiofrequency treatment for 4 minutes |
| patients to whom applied epidural injection without local anaesthetic | Active comparator | Procedure: servical transforaminal epidural steroid injection without local anaestheticPatients in Group 2 are given 4 mg of dexamethasone. The radiofrequency generator is adjusted so that the catheter needle tip temperature does not exceed 42 ºC, and they undergo pulsed radiofrequency treatment for 4 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients consisted of those who presented to our outpatient clinic with neck and arm pain, who had received medical and/or physical therapy but whose symptoms did not improve.
Key exclusion criteria (1 listed)
- The procedure was not performed on those with neurological deficits requiring surgery, those with known allergies to lidocaine and dexamethasone, those who had recently undergone head and neck surgery, diabetic patients with impaired blood sugar regulation, those who had received epidural steroid injections or depot steroids within the last 15 days, those with progressive neurological deficits, those with coagulation disorders (INR > 1.5; platelets < 100,000/mm³), those with any lesion or infection in the cervical region that would prevent epidural intervention, and pregnant women.
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 |
|---|---|---|
| servical transforaminal epidural steroid injection with local anaestheticThe interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device.Subsequently, patients in Group 1 receive 4 mg dexamethasone and 1cc lidocain. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC. | Procedure or surgery | patients to whom applied epidural injection with local anaesthetic |
| servical transforaminal epidural steroid injection without local anaestheticThe interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device.Subsequently, patients in Group 2 receive 4 mg dexamethasone. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC. | Procedure or surgery | patients to whom applied epidural injection without local anaesthetic |
Primary outcome
To compare whether the addition of a local anesthetic to combined DRG-pulsed RF and transforaminal anterior epidural steroid injection (TAESI) treatment makes a difference in clinical efficacy in patients with cervical disc herniation
Time frame: 6 months
In patients with radicular neck pain due to cervical disc herniation, the clinical efficacy of adding a local anesthetic during combined DRG-pulsed RF and transforaminal anterior epidural steroid injection (TAESI) was evaluated using the NRS (Numerical Rating Scale) to assess pain control.
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 9 Feb 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?
A study testing servical transforaminal epidural steroid injection with local anaesthetic and servical transforaminal epidural steroid injection without local anaesthetic in people with Transforaminal Epidural Injection and Dorsal Root Ganglion Stimulation, run by Aydin Adnan Menderes 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 9 Feb 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?
To compare whether the addition of a local anesthetic to combined DRG-pulsed RF and transforaminal anterior epidural steroid injection (TAESI) treatment makes a difference in clinical efficacy in patients with cervical disc herniation (time frame: 6 months). 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 9 Feb 2026.