Cutaneous Silent Period-Based Comparison of DRG-PRF and TFESI in Lumbar Radicular Pain

NCT07097532 | Active Not Recruiting

• 1 other identifier: CSP-DRGPRF-TFESI-2025
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Lumbar Radicular Pain; Spinal; Inhibition

Keywords

Cutaneous Silent Period; Lumbar Radicular Pain; Dorsal Root Ganglion Pulsed Radiofrequency; Transforaminal Epidural Eteroid Injection

Outcome Measures

Primary Outcomes (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.

  Baseline, Day 1, Week 1, and Month 1 post-procedure

Secondary Outcomes (1)

• Change in Clinical Outcomes: Pain Intensity and Functional Disability

  Baseline, Day 1, Week 1, and Month 1 post-procedure

Study Arms (3)

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.

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.

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.

Interventions

Radiofrequency PROCEDURE

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.

Also known as: Dorsal Root Ganglion Radiofrequency

DRG-PRF Group

Transforaminal Epidural Steroid Injection PROCEDURE

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.

Also known as: Transforaminal Epidural Steroid Injections

TFESI Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ahmet başarı: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Seker, 38080, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 30691969 BACKGROUND

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

  PMID: 14506711 BACKGROUND

• 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.

  PMID: 28087843 BACKGROUND

• 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.

  PMID: 32970918 BACKGROUND

• 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.

  PMID: 20492580 BACKGROUND

• 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.

  PMID: 25395111 BACKGROUND

MeSH Terms

Conditions

Inhibition, Psychological

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ahmet Basari, Pain Specialist, Neurologist

  Kayseri City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor responsible for CSP measurements is blinded to group allocation. No other parties are masked.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pain Specialist

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 31, 2025
• Study Start: July 8, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)