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 | Completed DMC

• 2 other identifiers: Epipul StudyComité Ético de HM Hospital
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

PRF Catheter; Epidural Steroid Injection; Neuropathic Pain; Interventional Pain Management; Epidural Pulsed Radiofrequency

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity measured by Visual Analogue Scale (VAS)

  Change in pain intensity measured by the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).

  Baseline to 6 months (with assessments at 1, 2, 4, and 6 months).

Secondary Outcomes (3)

• Change in neuropathic pain measured by DN4 questionnaireeuropathic pain, as measured by DN4 questionnaire

  Time Frame: Baseline to 6 months (assessments at 1, 2, 4, and 6 months).

• Change in functional disability measured by Oswestry Disability Index (ODI)

  Baseline to 6 months (assessments at 1, 2, 4, and 6 months)

• Change in overall improvement measured by Patient Global Impression of Improvement (PGI-I) questionnaire

  Baseline to 6 months (assessments at 1, 2, 4, and 6 months).

Other Outcomes (1)

• Number Needed to Treat (NNT) analysis for pain reduction

  Baseline to 6 months (assessments at 1, 2, 4, and 6 months).

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Participants received epidural pulsed radiofrequency with corticosteroid injection.

Procedure: Epidural Pulsed Radiofrequency; Drug: Betamethasone (Epidural Corticosteroid Injection)

Control Arm: Epidural Corticosteroid Injection

ACTIVE COMPARATOR

Participants received an epidural injection of 12 mg betamethasone in 8 ml sterile saline without pulsed radiofrequency.

Drug: Betamethasone (Epidural Corticosteroid Injection)

Interventions

Epidural Pulsed Radiofrequency PROCEDURE

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.

Experimental Arm

Betamethasone (Epidural Corticosteroid Injection) DRUG

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

Control Arm: Epidural Corticosteroid Injection; Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years old.
• Written informed consent obtained according to ICH/GCP and Spanish legislation prior to any study procedure.
• Pain VAS score of at least 5 points.
• Duration of pain lasting at least 3 months after back surgery despite conservative treatment.
• Leg-dominant radicular pain deemed neuropathic based on clinical history and examination.
• Responsiveness to selective radicular nerve block with bupivacaine 0.125%.
• Previous epidural steroid injection.

You may not qualify if:

• \. Pregnancy or lactation. 2. Participation in a study involving medicines or other clinical devices 4. Inability to follow instructions or collaborate during the study. 5. Findings in physical examination, clinical analysis abnormalities, or other medical, social, or psychosocial factors that, in the researcher's opinion, could negatively influence study outcomes 6. Presence of myelopathy, systemic diseases, infection (systemic or local), cancer, indication for immediate surgery, coagulation disorders, anticoagulants use, diabetes mellitus or multiple sclerosis.
• \. Life expectancy of less than one year. 8. Current diagnosis of a progressive neurological disease.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (4)

HM Monteprincipe University Hospital

Boadilla del Monte, Madrid, 28660, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

General Hospital Of Ciudad Real

Ciudad Real, 13005, Spain

Location

HM Sanchinarro University Hospital

Madrid, 28050, Spain

Location

Related Publications (4)

• Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications-a review. Acta Neurochir (Wien). 2011 Apr;153(4):763-71. doi: 10.1007/s00701-010-0881-5. Epub 2010 Nov 30.

  PMID: 21116663 BACKGROUND

• Gulduren Aydin LG, Akesen S, Turker YG, Gurbet A, Kilic Yilmaz V. Investigation of Effectiveness of Pulsed Radiofrequency With Multifunctional Epidural Electrode for Low Back Pain. Cureus. 2021 Dec 7;13(12):e20239. doi: 10.7759/cureus.20239. eCollection 2021 Dec.

  PMID: 35004054 BACKGROUND

• Abejon D, Garcia-del-Valle S, Fuentes ML, Gomez-Arnau JI, Reig E, van Zundert J. Pulsed radiofrequency in lumbar radicular pain: clinical effects in various etiological groups. Pain Pract. 2007 Mar;7(1):21-6. doi: 10.1111/j.1533-2500.2007.00105.x.

  PMID: 17305674 BACKGROUND

• Petersen EA, Schatman ME, Sayed D, Deer T. Persistent Spinal Pain Syndrome: New Terminology for a New Era. J Pain Res. 2021 Jun 8;14:1627-1630. doi: 10.2147/JPR.S320923. eCollection 2021. No abstract available.

  PMID: 34135626 BACKGROUND

MeSH Terms

Conditions

Failed Back Surgery Syndrome; post laminectomy syndrome; Neuralgia

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to treatment assignment. Care providers and investigators were aware of group allocation in order to perform the procedures. No additional parties were masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MBA, FIPP, CIPS, EDPM

Model Details: This is a randomized, controlled, multicenter, parallel-group study. Participants were assigned in a 1:1 ratio to receive either epidural corticosteroid injection alone (control group) or epidural pulsed radiofrequency combined with corticosteroid injection (experimental group).

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 5, 2025
• Study Start: January 2, 2021
• Primary Completion: March 30, 2024
• Study Completion: April 2, 2024
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: Data will be available from the publication date of the main results and for 5 years thereafter.
• Access Criteria: De-identified IPD, including baseline data, intervention details, and outcomes (VAS, ODI, DN4, PGI-I), will be available to qualified researchers upon reasonable request. Proposals require approval by the principal investigator and ethics committee. Access will be granted after signing a data use agreement and will be provided via secure electronic transfer.

Locations

ES (4)