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

Pulsed Epidural Radiofrequency Versus Epidural Steroid Injection in Patients With Failed Back Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for people who continue to have low back pain after spinal surgery, a condition called persistent spinal pain syndrome type II. Current treatments, such as epidural injections, often provide only limited relief. Doctors are testing a procedure called pulsed radiofrequency (PRF), given through a small catheter in the epidural space, with or without the addition of corticosteroids. The goal is to see if this treatment can reduce pain and improve daily function better than standard injections. About 130 patients took part, and their pain and quality of life were followed for several months after the procedure.

Detailed description

Persistent spinal pain syndrome type II (PSPS II) is a frequent and disabling condition encountered in Pain Units after lumbar surgery. Conventional therapeutic options such as epidural corticosteroid injections and epidurolysis often provide only partial or temporary benefit. Pulsed radiofrequency (PRF) delivered through a catheter into the epidural space has shown promising results compared to transforaminal approaches, offering a potential alternative for managing this challenging pain condition. The purpose of this randomized, controlled, multicenter clinical trial is to evaluate the efficacy and safety of epidural PRF with or without the addition of corticosteroids in patients with PSPS II. A total of 131 patients were enrolled and assigned to receive either epidural corticosteroids alone or PRF combined with corticosteroids. Pain intensity, functional status, neuropathic pain features, and global impression of improvement were assessed at multiple follow-up visits. The findings of this study aim to provide evidence-based guidance for interventional pain management in PSPS II.

Conditions

• Persistent Spinal Pain Syndrome Type II
• Failed Back Surgery Syndrome
• Chronic Low Back Pain
• Post-Laminectomy Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-02
• Primary completion: 2024-03-30
• Completion: 2024-04-02
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

4 sites across 1 country: Spain