About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone
Procedure/SurgeryFluoroscopic guidance was used in all cases with a C-arm system. The patient was prone with a pillow under the lower abdomen. Anteroposterior (AP) images were taken to identify the target level. The C-arm was angled 15-30° to project the spinous process over the contralateral facet ("scotty dog" view). Skin was infiltrated with lidocaine, and a 22-gauge RF cannula was advanced under fluoroscopy. The tip was positioned in the dorsal-cranial quadrant of the intervertebral foramen on lateral images. PRF was applied with 4 cycles at 42°C for 8 minutes after sensory/motor testing. Injections of lidocaine and triamcinolone followed. In caudal neuroplasty, an epidural catheter was placed using the sacral hiatus as a guide. Fluoroscopy confirmed catheter position. Contrast was injected to confirm spread, and hyaluronidase and lidocaine were administered. Afterward, the catheter was removed.
Treatment groups
Trial outcomes
Primary outcomes
improvement in pain intensity using VAS score
The most effective modality in reducing the intensity of pain in patients with lumbar radicular pain
Secondary outcomes
duration of analgesic effect
Duration of the analgesic effect following RF procedures
Locations
Sponsors and contacts
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