Caudal Neuroplasty Using Epidural Catheter Combined with Pulsed Radiofrequency (versus Pulsed Radiofrequency Alone

NCT06711419 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

  • Disc Herniation

Interventions

PROCEDURE

f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone

Fluoroscopic 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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Kilani Ali Abdel-salam, PROF · Assiut University

  • Saeid Metwally El Sawy, DR · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2027-09-10
Completion
2028-03-10

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Read the full study record

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View NCT06711419 on ClinicalTrials.gov