Persistent Post-Lumbar Surgery Pain Syndrome (PSPS) Type II is a Common Condition Encountered in Pain Units, With Limited Available Therapeutic Options. Epidural Pulsed Radiofrequency (PRF) Administered Via Catheter Has Demonstrated Greater Efficacy Compared to the Transforaminal Approach. This Rand

NACompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

January 2, 2021

Primary Completion Date

March 30, 2024

Study Completion Date

April 2, 2024

Conditions
Persistent Spinal Pain Syndrome Type IIFailed Back Surgery SyndromeChronic Low Back PainPost-Laminectomy Syndrome
Interventions
PROCEDURE

Epidural Pulsed Radiofrequency

Pulsed radiofrequency applied via a guidable epidural catheter electrode (Cosman RCE-E401519-P), advanced through the sacral hiatus to the target lumbar or sacral root (L5 and/or S1) under fluoroscopic guidance. Parameters: 45 V, 2 Hz, 20 ms pulses, applied at a single location with continuous temperature monitoring (≤42°C). Procedure performed with Cosman C4 generator.

DRUG

Betamethasone (Epidural Corticosteroid Injection)

Epidural injection of 12 mg betamethasone diluted in 8 ml sterile saline, administered via the sacral hiatus under fluoroscopic guidance.

Trial Locations (4)

13005

General Hospital Of Ciudad Real, Ciudad Real

28050

HM Sanchinarro University Hospital, Madrid

28222

Hospital Puerta de Hierro, Majadahonda

28660

HM Monteprincipe University Hospital, Boadilla del Monte

All Listed Sponsors
lead

Puerta de Hierro University Hospital

OTHER

NCT07156513 - Persistent Post-Lumbar Surgery Pain Syndrome (PSPS) Type II is a Common Condition Encountered in Pain Units, With Limited Available Therapeutic Options. Epidural Pulsed Radiofrequency (PRF) Administered Via Catheter Has Demonstrated Greater Efficacy Compared to the Transforaminal Approach. This Rand | Biotech Hunter | Biotech Hunter