Caudal Neuroplasty Using Epidural Catheter Combined with Pulsed Radiofrequency (versus Pulsed Rad… (NCT06711419) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Caudal Neuroplasty Using Epidural Catheter Combined with Pulsed Radiofrequency (versus Pulsed Radiofrequency Alone
70 participantsStarted 2024-12-10
Plain-language summary
Evaluating the superiority of caudal neuroplasty using epidural catheter (Perifix® Complete Set 16 G) combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone targeting the dorsal root ganglion In patients with lumbar radicular pain on pain reduction and quality of life within six months follow up.
Who can participate
Age range
20 Years – 80 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:
* Adult patients aged 20-80 years old complaining with lumbosacral radicular pain.
* pain intensity ≥4 out of 10 on the numerical rating scale (NRS).
* dominant leg pain with less intense back pain.
* previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications.
* Epidural injections administered ≥12 weeks prior to recruitment were permitted because most of the patients visiting our clinic had a history of interlaminar or transforaminal epidural injections.
* Magnetic resonance imaging (MRI) was obtained in all patients and the diagnosis of lumbar disc prolapse was confirmed.
Exclusion Criteria:
* patient refusal to participate in the study,
* age \<20 years,
* unbearable pain \>9-points on NRS, pain \<4-points on NRS.
* signs of progressive motor weakness or neurologic deficits.
* Instability of the spine
* allergies to steroids or contrast dyes.5
* coagulopathy.
* steroid injection within the previous 12 weeks.
* systemic infection, injection site infection.
* malignancy.
* unstable medical or psychiatric condition
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.