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

NCT07097532 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-08-05

No results posted yet for this study

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

Interventions

PROCEDURE

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.

PROCEDURE

Transforaminal Epidural Steroid Injection

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.

Sponsors & Collaborators

  • ahmet başarı

    lead OTHER_GOV

Principal Investigators

  • Ahmet Basari, Pain Specialist, Neurologist · Kayseri City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2025-08-25
Completion
2025-08-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07097532 on ClinicalTrials.gov