Lumbar Radicular PainCSP-LRPNCT07097532
Cutaneous Silent Period-Based Comparison of DRG-PRF and TFESI in Lumbar Radicular Pain
A study testing Radiofrequency and Transforaminal Epidural Steroid Injection in people with Lumbar Radicular Pain and Spinal, run by ahmet başarı at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study compares the effects of two interventional treatments, dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI), on patients with lumbar radicular pain (LRP). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Radicular Pain, Spinal, Inhibition
- What is being tested?
- Radiofrequency and Transforaminal Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2025to 25 Aug 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Clinically and radiologically confirmed lumbar radicular pain (LRP) due to unilateral intervertebral disc herniation, confirmed by MRI and physical examination
- Symptom duration greater than 3 months
- Baseline pain score of ≥4 on the 11-point Numerical Rating Scale (NRS-11)
- Inadequate response to conservative treatment (e.g., medication or physical therapy)
Who cannot join
- Unstable or uncontrolled psychiatric illness
- Pregnancy
- Bleeding diathesis
- Known allergy to any procedural agent (e.g., local anesthetics, corticosteroids, contrast media)
- Prior lumbar surgery
- Spondylolisthesis
Show all 18Show fewer
- Compression fracture
- Discitis
- Bilateral or sequestered disc herniation
- Moderate-to-severe spinal stenosis
- Diabetes mellitus
- Polyneuropathy
- Fibromyalgia
- Movement disorders
- Regular use of antidepressants or tramadol
- Regular use of pregabalin or gabapentin
- Chronic alcohol use
- Noncompliance with follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cutaneous Silent Period-Based Comparison of Dorsal Root Ganglion Pulsed Radiofrequency and Transforaminal Epidural Steroid Injection in Lumbar Radicular Pain
This prospective clinical study compares the effects of two interventional treatments, dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI), on patients with lumbar radicular pain (LRP). A third group of healthy individuals is included as a control group to provide baseline cutaneous silent period (CSP) values.
The CSP is a neurophysiological marker of spinal inhibition. The study aims to evaluate whether these treatments affect pain levels, functional disability, and CSP parameters over time. Participants with LRP will receive either DRG-PRF or TFESI, while healthy controls will undergo CSP testing only.
The findings may provide insight into the effects of these interventions on segmental nociceptive processing and inform treatment strategies for neuropathic low back pain.
Read the detailed description
Lumbar radicular pain (LRP) is one of the most common causes of low back pain (1). It frequently results from disc herniation at the L4-5 or L5-S1 levels or from irritation of spinal nerve roots due to other degenerative conditions (2). Transforaminal epidural steroid injection (TFESI) and dorsal root ganglion pulsed radiofrequency (DRG-PRF) are minimally invasive interventional procedures used in the treatment of this condition. However, data objectively comparing the effects of these interventions on segmental nociceptive processing in humans are limited (3,4).
This prospective clinical study aims to evaluate both the clinical and neurophysiological effects of DRG-PRF and TFESI in individuals with LRP. The cutaneous silent period (CSP), a non-invasive electrophysiological marker that reflects spinal inhibitory function, will be used as an objective assessment tool. CSP is a polysynaptic spinal reflex in which a nociceptive stimulus conducted via A-delta fibers causes temporary suppression of voluntary motor activity (5). It represents the electrophysiological correlate of a protective reflex involving both sensory and motor pathways and enables functional assessment of thinly myelinated sensory fibers using standard neurophysiological equipment (6).
The study will include three groups: a DRG-PRF group, a TFESI group, and a healthy control group with no spinal pathology. Participants in the DRG-PRF and TFESI groups will be randomly allocated to treatment arms according to their order of presentation at the outpatient clinic. All participants will undergo baseline CSP recordings. In the treatment groups, CSP will be reassessed on Day 1, Week 1, and Month 1 following the intervention. CSP measurements will be conducted by an experienced electrophysiologist who is blinded to the treatment group. In addition, pain severity using the Numeric Rating Scale (NRS) and functional disability using the Oswestry Disability Index (ODI) will be evaluated in the treatment groups.
The DRG-PRF group will receive fluoroscopy-guided pulsed radiofrequency treatment at the L4-5 and L5-S1 lumbar levels using a standard 42°C protocol. The TFESI group will receive transforaminal corticosteroid injections at the same spinal levels. All procedures will be performed under sterile conditions by an experienced pain specialist.
The primary outcome of the study is to assess changes in CSP parameters, specifically onset latency and duration. Secondary outcomes include changes in pain intensity and functional capacity. The inclusion of a healthy control group will allow for comparison of CSP responses against normative values.
The study is expected to yield new insights into the neurophysiological effects of interventional pain treatments and to clarify the potential utility of CSP in monitoring treatment response in lumbar radicular pain. The findings may support more personalized clinical decision-making and enhance understanding of the underlying spinal mechanisms associated with these procedures.
- Conditions
- Lumbar Radicular Pain, Spinal, Inhibition
- Being tested
- Radiofrequency, Transforaminal Epidural Steroid Injection
- Keywords
- Cutaneous Silent Period, Lumbar Radicular Pain, Dorsal Root Ganglion Pulsed Radiofrequency, Transforaminal Epidural Eteroid Injection
- Medical subject headings
- Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyProcedure or surgery
Also called Dorsal Root Ganglion Radiofrequency
Under sterile conditions and fluoroscopic guidance, pulsed radiofrequency treatment was applied unilaterally to the dorsal root ganglia at the L4-L5 and L5-S1 spinal levels. Sensory and motor stimulation were performed to confirm appropriate electrode placement. Pulsed radiofrequency was delivered at 45 volts for 300 seconds at 42°C using standard radiofrequency equipment. Patients were monitored for three hours following the procedure, and cutaneous silent period (CSP) recordings were obtained on the same day and during follow-up assessments.
Transforaminal Epidural Steroid InjectionProcedure or surgery
Also called Transforaminal Epidural Steroid Injections
Using a fluoroscopic C-arm device, transforaminal epidural steroid injection (TFESI) was performed at the L4-L5 and L5-S1 foraminal levels. At each level, a total of 4 mL of solution containing 16 mg of dexamethasone and sterile saline was administered following confirmation of appropriate contrast spread. Negative aspiration was verified prior to injection. Cutaneous silent period (CSP) measurements were conducted on the same day and at designated follow-up intervals.
| Study group | Role | What they receive |
|---|---|---|
| DRG-PRF Group | Experimental | Patients diagnosed with lumbar radicular pain underwent pulsed radiofrequency treatment targeting the dorsal root ganglion at the L4-5 or L5-S1 spinal levels under fluoroscopic guidance. The cutaneous silent period (CSP), pain intensity measured by the Numeric Rating Scale (NRS), and functional disability assessed by the Oswestry Disability Index (ODI) were evaluated before and after the intervention. Receives: Procedure: Radiofrequency |
| TFESI Group | Active comparator | Patients diagnosed with lumbar radicular pain underwent transforaminal epidural steroid injections at the L4-5 or L5-S1 spinal levels under fluoroscopic guidance. The cutaneous silent period (CSP), pain intensity measured by the Numeric Rating Scale (NRS), and functional disability assessed by the Oswestry Disability Index (ODI) were evaluated before and after the intervention. Receives: Procedure: Transforaminal Epidural Steroid Injection |
| Healthy Control Group | No intervention | Healthy individuals with no known spinal pathology or neuropathic pain underwent cutaneous silent period (CSP) evaluation for comparison purposes. No interventional procedures were performed in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cutaneous Silent Period (CSP) Parameters
Evaluation of changes in electrophysiological parameters of the cutaneous silent period (CSP), including onset latency, offset latency, and duration, recorded from the tibialis anterior muscle following sural nerve stimulation. These parameters are used to assess segmental spinal inhibitory function and to evaluate the modulatory effects of dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI) in patients with lumbar radicular pain.
Measured: Baseline, Day 1, Week 1, and Month 1 post-procedure
Secondary outcomes (1)
Change in Clinical Outcomes: Pain Intensity and Functional Disability
Clinical outcomes will be assessed using the 11-point Numerical Rating Scale (NRS-11) for pain intensity and the Oswestry Disability Index (ODI) for functional disability. NRS-11 scores will be measured at baseline, day 1, week 1, and month 1, while ODI scores will be evaluated at baseline and month 1. These measures will be used to determine the clinical effectiveness of dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI) in patients with lumbar radicular pain.
Measured: Baseline, Day 1, Week 1, and Month 1 post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start8 Jul 2025
- Primary completion25 Aug 2025 (estimated)
- Study completion25 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lumbar Radicular PainStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model with three groups: two patient groups with lumbar radicular pain, randomized to receive either dorsal root ganglion pulsed radiofrequency (DRG-PRF) or transforaminal epidural steroid injection (TFESI), and one healthy control group undergoing cutaneous silent period (CSP) measurement only. Patients are randomly allocated to the intervention arms. Each group is evaluated independently, with no crossover or sequential interventions. CSP, pain, and disability outcomes are assessed at baseline and at follow-up time points for comparison.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- ahmet başarı
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, ahmet başarı, Kayseri City Hospital
- Investigators
- Ahmet Basari, Pain Specialist, Neurologist, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097532
- Sponsor's protocol ID
- CSP-DRGPRF-TFESI-2025
- Acronym
- CSP-LRP
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared due to institutional data protection policy and ethical constraints.
Publications
Kofler M, Leis AA, Valls-Sole J. Cutaneous silent periods - Part 1: Update on physiological mechanisms. Clin Neurophysiol. 2019 Apr;130(4):588-603. doi: 10.1016/j.clinph.2019.01.002. Epub 2019 Jan 18.
PubMed 30691969Floeter MK. Cutaneous silent periods. Muscle Nerve. 2003 Oct;28(4):391-401. doi: 10.1002/mus.10447.
PubMed 14506711Gunduz OH, Sencan S, Ercalik T, Suhaimi A. Recovery of H-Reflex with Transforaminal Epidural Steroid Injection in S1 Radiculopathy. Pain Med. 2017 Aug 1;18(8):1594-1597. doi: 10.1093/pm/pnw303. No abstract available.
PubMed 28087843Vigneri S, Sindaco G, La Grua M, Zanella M, Paci V, Vinci FM, Sciacca C, Merlini A, Pari G. Long-term Inhibition of Soleus H-reflex with Epidural Adhesiolysis and Pulsed Radiofrequency in Lumbosacral Neuropathic Pain. Pain Pract. 2021 Mar;21(3):277-284. doi: 10.1111/papr.12955. Epub 2020 Oct 25.
PubMed 32970918Van Boxem K, Cheng J, Patijn J, van Kleef M, Lataster A, Mekhail N, Van Zundert J. 11. Lumbosacral radicular pain. Pain Pract. 2010 Jul-Aug;10(4):339-58. doi: 10.1111/j.1533-2500.2010.00370.x. Epub 2010 May 17.
PubMed 20492580Manchikanti L, Singh V, Falco FJ, Benyamin RM, Hirsch JA. Epidemiology of low back pain in adults. Neuromodulation. 2014 Oct;17 Suppl 2:3-10. doi: 10.1111/ner.12018.
PubMed 25395111
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Silent Period-Based Comparison of Dorsal Root Ganglion Pulsed Radiofrequency and Transforaminal Epidural Steroid Injection in Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT07097532
- Acronym / sponsor ID
- CSP-LRP / CSP-DRGPRF-TFESI-2025
- Conditions
- Lumbar Radicular Pain, Spinal, Inhibition
- Keywords
- Cutaneous Silent Period, Lumbar Radicular Pain, Dorsal Root Ganglion Pulsed Radiofrequency, Transforaminal Epidural Eteroid Injection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- ahmet başarıOther government
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 25 Aug 2025 (estimated)
- First posted
- 31 Jul 2025 (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 prospective clinical study compares the effects of two interventional treatments, dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI), on patients with lumbar radicular pain (LRP). A third group of healthy individuals is included as a control group to provide baseline cutaneous silent period (CSP) values.
The CSP is a neurophysiological marker of spinal inhibition. The study aims to evaluate whether these treatments affect pain levels, functional disability, and CSP parameters over time. Participants with LRP will receive either DRG-PRF or TFESI, while healthy controls will undergo CSP testing only.
The findings may provide insight into the effects of these interventions on segmental nociceptive processing and inform treatment strategies for neuropathic low back pain.
Detailed description
Lumbar radicular pain (LRP) is one of the most common causes of low back pain (1). It frequently results from disc herniation at the L4-5 or L5-S1 levels or from irritation of spinal nerve roots due to other degenerative conditions (2). Transforaminal epidural steroid injection (TFESI) and dorsal root ganglion pulsed radiofrequency (DRG-PRF) are minimally invasive interventional procedures used in the treatment of this condition. However, data objectively comparing the effects of these interventions on segmental nociceptive processing in humans are limited (3,4).
This prospective clinical study aims to evaluate both the clinical and neurophysiological effects of DRG-PRF and TFESI in individuals with LRP. The cutaneous silent period (CSP), a non-invasive electrophysiological marker that reflects spinal inhibitory function, will be used as an objective assessment tool. CSP is a polysynaptic spinal reflex in which a nociceptive stimulus conducted via A-delta fibers causes temporary suppression of voluntary motor activity (5). It represents the electrophysiological correlate of a protective reflex involving both sensory and motor pathways and enables functional assessment of thinly myelinated sensory fibers using standard neurophysiological equipment (6).
The study will include three groups: a DRG-PRF group, a TFESI group, and a healthy control group with no spinal pathology. Participants in the DRG-PRF and TFESI groups will be randomly allocated to treatment arms according to their order of presentation at the outpatient clinic. All participants will undergo baseline CSP recordings. In the treatment groups, CSP will be reassessed on Day 1, Week 1, and Month 1 following the intervention. CSP measurements will be conducted by an experienced electrophysiologist who is blinded to the treatment group. In addition, pain severity using the Numeric Rating Scale (NRS) and functional disability using the Oswestry Disability Index (ODI) will be evaluated in the treatment groups.
The DRG-PRF group will receive fluoroscopy-guided pulsed radiofrequency treatment at the L4-5 and L5-S1 lumbar levels using a standard 42°C protocol. The TFESI group will receive transforaminal corticosteroid injections at the same spinal levels. All procedures will be performed under sterile conditions by an experienced pain specialist.
The primary outcome of the study is to assess changes in CSP parameters, specifically onset latency and duration. Secondary outcomes include changes in pain intensity and functional capacity. The inclusion of a healthy control group will allow for comparison of CSP responses against normative values.
The study is expected to yield new insights into the neurophysiological effects of interventional pain treatments and to clarify the potential utility of CSP in monitoring treatment response in lumbar radicular pain. The findings may support more personalized clinical decision-making and enhance understanding of the underlying spinal mechanisms associated with these procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study uses a parallel assignment model with three groups: two patient groups with lumbar radicular pain, randomized to receive either dorsal root ganglion pulsed radiofrequency (DRG-PRF) or transforaminal epidural steroid injection (TFESI), and one healthy control group undergoing cutaneous silent period (CSP) measurement only. Patients are randomly allocated to the intervention arms. Each group is evaluated independently, with no crossover or sequential interventions. CSP, pain, and disability outcomes are assessed at baseline and at follow-up time points for comparison.
| Arm | Type | Receives |
|---|---|---|
| DRG-PRF Group | Experimental | Procedure: RadiofrequencyPatients diagnosed with lumbar radicular pain underwent pulsed radiofrequency treatment targeting the dorsal root ganglion at the L4-5 or L5-S1 spinal levels under fluoroscopic guidance. The cutaneous silent period (CSP), pain intensity measured by the Numeric Rating Scale (NRS), and functional disability assessed by the Oswestry Disability Index (ODI) were evaluated before and after the intervention. |
| TFESI Group | Active comparator | Procedure: Transforaminal Epidural Steroid InjectionPatients diagnosed with lumbar radicular pain underwent transforaminal epidural steroid injections at the L4-5 or L5-S1 spinal levels under fluoroscopic guidance. The cutaneous silent period (CSP), pain intensity measured by the Numeric Rating Scale (NRS), and functional disability assessed by the Oswestry Disability Index (ODI) were evaluated before and after the intervention. |
| Healthy Control Group | No intervention | –Healthy individuals with no known spinal pathology or neuropathic pain underwent cutaneous silent period (CSP) evaluation for comparison purposes. No interventional procedures were performed in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Clinically and radiologically confirmed lumbar radicular pain (LRP) due to unilateral intervertebral disc herniation, confirmed by MRI and physical examination
- Symptom duration greater than 3 months
- Baseline pain score of ≥4 on the 11-point Numerical Rating Scale (NRS-11)
- Inadequate response to conservative treatment (e.g., medication or physical therapy)
Key exclusion criteria (18 listed)
- Unstable or uncontrolled psychiatric illness
- Pregnancy
- Bleeding diathesis
- Known allergy to any procedural agent (e.g., local anesthetics, corticosteroids, contrast media)
- Prior lumbar surgery
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 |
|---|---|---|
| RadiofrequencyAlso: Dorsal Root Ganglion RadiofrequencyUnder sterile conditions and fluoroscopic guidance, pulsed radiofrequency treatment was applied unilaterally to the dorsal root ganglia at the L4-L5 and L5-S1 spinal levels. Sensory and motor stimulation were performed to confirm appropriate electrode placement. Pulsed radiofrequency was delivered at 45 volts for 300 seconds at 42°C using standard radiofrequency equipment. Patients were monitored for three hours following the procedure, and cutaneous silent period (CSP) recordings were obtained on the same day and during follow-up assessments. | Procedure or surgery | DRG-PRF Group |
| Transforaminal Epidural Steroid InjectionAlso: Transforaminal Epidural Steroid InjectionsUsing a fluoroscopic C-arm device, transforaminal epidural steroid injection (TFESI) was performed at the L4-L5 and L5-S1 foraminal levels. At each level, a total of 4 mL of solution containing 16 mg of dexamethasone and sterile saline was administered following confirmation of appropriate contrast spread. Negative aspiration was verified prior to injection. Cutaneous silent period (CSP) measurements were conducted on the same day and at designated follow-up intervals. | Procedure or surgery | TFESI Group |
Primary outcome
Change in Cutaneous Silent Period (CSP) Parameters
Time frame: Baseline, Day 1, Week 1, and Month 1 post-procedure
Evaluation of changes in electrophysiological parameters of the cutaneous silent period (CSP), including onset latency, offset latency, and duration, recorded from the tibialis anterior muscle following sural nerve stimulation. These parameters are used to assess segmental spinal inhibitory function and to evaluate the modulatory effects of dorsal root ganglion pulsed radiofrequency (DRG-PRF) and transforaminal epidural steroid injection (TFESI) in patients with lumbar radicular pain.
1 secondary outcome
Change in Clinical Outcomes: Pain Intensity and Functional Disability
Time frame: Baseline, Day 1, Week 1, and Month 1 post-procedure
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 5 Aug 2025.
- Background: PubMed 30691969Kofler M, Leis AA, Valls-Sole J. Cutaneous silent periods - Part 1: Update on physiological mechanisms. Clin Neurophysiol. 2019 Apr;130(4):588-603. doi: 10.1016/j.clinph.2019.01.002. Epub 2019 Jan 18.
- Results publication: PubMed 14506711Floeter MK. Cutaneous silent periods. Muscle Nerve. 2003 Oct;28(4):391-401. doi: 10.1002/mus.10447.
- Results publication: PubMed 28087843Gunduz OH, Sencan S, Ercalik T, Suhaimi A. Recovery of H-Reflex with Transforaminal Epidural Steroid Injection in S1 Radiculopathy. Pain Med. 2017 Aug 1;18(8):1594-1597. doi: 10.1093/pm/pnw303. No abstract available.
- Results publication: PubMed 32970918Vigneri S, Sindaco G, La Grua M, Zanella M, Paci V, Vinci FM, Sciacca C, Merlini A, Pari G. Long-term Inhibition of Soleus H-reflex with Epidural Adhesiolysis and Pulsed Radiofrequency in Lumbosacral Neuropathic Pain. Pain Pract. 2021 Mar;21(3):277-284. doi: 10.1111/papr.12955. Epub 2020 Oct 25.
- Results publication: PubMed 20492580Van Boxem K, Cheng J, Patijn J, van Kleef M, Lataster A, Mekhail N, Van Zundert J. 11. Lumbosacral radicular pain. Pain Pract. 2010 Jul-Aug;10(4):339-58. doi: 10.1111/j.1533-2500.2010.00370.x. Epub 2010 May 17.
- Results publication: PubMed 25395111Manchikanti L, Singh V, Falco FJ, Benyamin RM, Hirsch JA. Epidemiology of low back pain in adults. Neuromodulation. 2014 Oct;17 Suppl 2:3-10. doi: 10.1111/ner.12018.
- Individual participant dataSharing planned: No. The individual participant data will not be shared due to institutional data protection policy and ethical constraints.
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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.
Ahmet Basari, Pain Specialist, Neurologist principal investigator
Kayseri City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency and Transforaminal Epidural Steroid Injection in people with Lumbar Radicular Pain and Spinal, run by ahmet başarı 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 5 inclusion and 18 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 5 Aug 2025. 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 in Cutaneous Silent Period (CSP) Parameters (time frame: Baseline, Day 1, Week 1, and Month 1 post-procedure). 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 NCT07097532, which also lists 6 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 5 Aug 2025.