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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

NCT07156513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Puerta de Hierro University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-02
Primary Completion
2024-03-30
Completion
2024-04-02

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156513 on ClinicalTrials.gov