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Persistent Spinal Pain Syndrome Type IIEPIPULNCT07156513

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

A study testing Epidural Pulsed Radiofrequency and Betamethasone (Epidural Corticosteroid Injection) in people with Persistent Spinal Pain Syndrome Type II and Failed Back Surgery Syndrome, run by Puerta de Hierro University Hospital at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Epidural Pulsed Radiofrequency and Betamethasone (Epidural Corticosteroid Injection)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
4 sitesSpain
Study dates
2 Jan 2021to 2 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1. 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.
  • 7. Life expectancy of less than one year. 8. Current diagnosis of a progressive neurological disease.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • HM Monteprincipe University Hospital

    Boadilla del Monte, Madrid, 28660

  • General Hospital Of Ciudad Real

    Ciudad Real, 13005

  • HM Sanchinarro University Hospital

    Madrid, 28050

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Epidural Pulsed Radiofrequency, Betamethasone (Epidural Corticosteroid Injection)
Keywords
PRF Catheter, Epidural Steroid Injection, Neuropathic Pain, Interventional Pain Management, Epidural Pulsed Radiofrequency
Medical subject headings
Failed Back Surgery Syndrome, post laminectomy syndrome, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural Pulsed RadiofrequencyProcedure or surgery

    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.

Study groups in NCT07156513
Study groupRoleWhat they receive
Experimental ArmExperimentalParticipants received epidural pulsed radiofrequency with corticosteroid injection.
Receives: Procedure: Epidural Pulsed Radiofrequency; Drug: Betamethasone (Epidural Corticosteroid Injection)
Control Arm: Epidural Corticosteroid InjectionActive comparatorParticipants received an epidural injection of 12 mg betamethasone in 8 ml sterile saline without pulsed radiofrequency.
Receives: Drug: Betamethasone (Epidural Corticosteroid Injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (3)

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

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

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

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

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

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

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

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study start2 Jan 2021
  3. Primary completion30 Mar 2024
  4. Study completion2 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Participant
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07156513
Sponsor's protocol ID
Epipul Study
Other IDs
Comité Ético de HM Hospital
Acronym
EPIPUL
Status last verified
Aug 2025
First submitted
13 Aug 2025
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results reported in this article will be available upon reasonable request to the Principal Investigator (Dr. Agustín Mendiola de la Osa) after publication. Data will be shared for research purposes only, following approval of a methodologically sound proposal and under a data access agreement.

Publications

  • 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.

    PubMed 21116663

  • 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.

    PubMed 35004054

  • 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.

    PubMed 17305674

  • 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.

    PubMed 34135626

Questions about this trial

What is this clinical trial studying?

A study testing Epidural Pulsed Radiofrequency and Betamethasone (Epidural Corticosteroid Injection) in people with Persistent Spinal Pain Syndrome Type II and Failed Back Surgery Syndrome, run by Puerta de Hierro University Hospital at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07156513, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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