Cutaneous Silent Period-Based Comparison of DRG-PRF and TFESI in Lumbar Radicular Pain (NCT07097532) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cutaneous Silent Period-Based Comparison of DRG-PRF and TFESI in Lumbar Radicular Pain
Turkey (Türkiye)54 participantsStarted 2025-07-08
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* Regular use of pregabalin or gabapentin
* Chronic alcohol use
* Noncompliance with follow-up
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Cutaneous Silent Period (CSP) Parameters
Timeframe: Baseline, Day 1, Week 1, and Month 1 post-procedure