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NCT Number: 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

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.

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Key information

Conditions

Persistent Spinal Pain Syndrome Type II Back Pain Chronic Low Back Pain Failed Back Surgery Syndrome Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Post-Laminectomy Syndrome Postoperative Complications Signs and Symptoms post laminectomy syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HM Monteprincipe University Hospital, Boadilla del Monte, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

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

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

Secondary outcomes

  1. Change in neuropathic pain measured by DN4 questionnaireeuropathic pain, as measured by DN4 questionnaire

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

    Description: Neuropathic pain assessed using the Douleur Neuropathique 4 Questions (DN4), with scores ranging from 0 to 10. Higher scores indicate greater neuropathic pain.

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

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

    Description: Functional disability assessed using the Oswestry Disability Index (ODI), with scores ranging from 0% (no disability) to 100% (maximum disability).

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

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

    Description: Overall patient improvement assessed using the Patient Global Impression of Improvement (PGI-I) scale, ranging from 1 (very much improved) to 7 (very much worse).

Other outcomes

  1. Number Needed to Treat (NNT) analysis for pain reduction

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

    Description: Number Needed to Treat (NNT) will be calculated based on the proportion of patients achieving clinically relevant reductions in pain intensity on the VAS (e.g., ≥2-point or ≥3-point reduction). Lower NNT values indicate greater treatment efficacy

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study title

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

Acronym: EPIPUL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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