High Voltage VS Standard Voltage Radiofrequency in a Patient With Failed Back Surgery Syndrome (NCT05563636) | Clinical Trial Compass
CompletedNot Applicable
High Voltage VS Standard Voltage Radiofrequency in a Patient With Failed Back Surgery Syndrome
Egypt90 participantsStarted 2022-12-01
Plain-language summary
Postoperative lumbar spine pain syndrome (FBSS) refers to patients who have undergone surgery for lumbar spine disease one or more times and still have intractable lumbosacral pain after surgery, with or without lower limb sensory and motor dysfunction. Pain is the main reason for reducing patients' quality of life. Hussain and Erdek believe that despite up to 3 months of postoperative intervention, pain may still exist. Since persistent pain seriously affects patients' daily life and work, optimizing the FBSS treatment plan and improving the quality of life of FBSS patients cannot be ignored. At present, the treatment methods for neuropathic pain radiated to the lower extremity after lumbar spine surgery mainly include oral drug therapy, nerve block, pulsed radio frequency (PRF) and spinal cord electrical stimulation, and other minimally invasive interventional methods. Still, there is no domestic or foreign treatment method is reported in the literature to be effective.
Who can participate
Age range
20 Years – 60 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:
* Patients who have a history of lumbar spine surgery without instrumentation. , have clear symptoms of lumbar nerve root irritation, and unilateral lower extremity symptoms, and the straight leg raising test is positive
Exclusion Criteria:
* Mechanical compression to nerve root
* Spondylolisthesis, retrolithesis
* Spondylodiscitis
* Lumbar canal stenosis
* Inflammatory low back pain
* Coagulopathy
* Local anesthetic allergy
* Infection at the site of injection
* Systemic infection
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 Oswestry Disability Index (ODI)
Timeframe: assessing a change in Change ODI from Baseline at 6 months