Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation (PRATS)
Sciatica, Lumbar Disc Herniation
About this trial
This is an interventional treatment trial for Sciatica focused on measuring sciatica, lumbar disc herniation, radiofrequency, non invasive treatment
Eligibility Criteria
Inclusion Criteria:
- Eligible patients had radiologically confirmed disk herniation, and had received a diagnosis from an attending neurologist of an incapacitating lumbosacral radicular syndrome that had lasted for at least 12 weeks. Correlation of magnetic resonance imaging (MRI) findings with symptoms was required.
- The occurrence of another episode of symptoms similar to those of the current episode during the previous 12 months were not considered contraindications
Exclusion Criteria:
- Patients presenting with previous spine surgery, spondylolisthesis, cauda equina syndrome, muscle paralysis, or insufficient strength to move against gravity were excluded.
- Vertebral canal stenosis
- Other exclusion criteria were cardiac pace-maker implant, pregnancy, or severe coexisting disease.
Sites / Locations
- Centro Sana
- Alessandro Napoli
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Pulsed Radiofrequency
Transforaminal Epidural Steroid Injection
Aseptic technique was adopted. Imaging guided (CT) catheter needle (active tip electrode) was inserted and a sensory stimulation test was carried out using an RF generator. The catheter needle was then advanced toward the DRG until the patient reported a tingling sensation and/or dysesthesia at less than 0.3V. PRF treatment was administered at 5 Hz and a 2 ms pulsed width for 10 minutes at 45V under the constraint that the electrode tip temperature not exceed 42°C. Finally, patients received 1mL lidocaine 20mg/mL mixed with 2mL dexamethasone 10mg/mL.
Aseptic technique was adopted. Imaging guided (CT) catheter needle (active tip electrode) was inserted and a sensory stimulation test was carried out using an RF generator. The catheter needle was then advanced toward the DRG until the patient reported a tingling sensation and/or dysesthesia at less than 0.3V. After 10 minutes await (as per pRF), patients received 1mL lidocaine 20mg/mL mixed with 2mL dexamethasone 10mg/mL.