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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).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Kayseri City Hospital

    Kayseri, Seker, 38080

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07097532
Study groupRoleWhat they receive
DRG-PRF GroupExperimentalPatients 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 GroupActive comparatorPatients 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 GroupNo interventionHealthy 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.

  1. 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)
  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.

  1. First posted31 Jul 2025
  2. Study start8 Jul 2025
  3. Primary completion25 Aug 2025 (estimated)
  4. Study completion25 Aug 2025 (estimated)

Resources

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)
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 30691969
  • Floeter MK. Cutaneous silent periods. Muscle Nerve. 2003 Oct;28(4):391-401. doi: 10.1002/mus.10447.

    PubMed 14506711
  • Gunduz 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 28087843
  • Vigneri 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 32970918
  • Van 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 20492580
  • Manchikanti 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

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.

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