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New hope for failed back surgery? electrical pulses vs steroid shots

NCT ID NCT07156513

Symptom relief Sponsor: Puerta de Hierro University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested two treatments for people with ongoing back pain after spinal surgery: pulsed radiofrequency (a procedure using mild electrical pulses) and a standard steroid injection. About 130 patients were followed for several months to see which approach reduced pain and improved daily function better. The goal is to find a more effective way to manage this difficult condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pulsed radiofrequency (a procedure using electrical pulses) and betamethasone (a steroid drug)
What this could lead to
If successful, this could offer a more effective, non-surgical option for managing chronic back pain after failed surgery.
What could go wrong
This is a small, completed trial, so results may not apply to everyone. The procedure is still experimental and may not work better than standard steroid injections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

131 people

The number who actually took part.

Started

Jan 2021

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men and women over 18 years old. 2. Written informed consent obtained according to ICH/GCP and Spanish legislation prior to any study procedure. 3. Pain VAS score of at least 5 points. 4. Duration of pain lasting at least 3 months after back surgery despite conservative treatment. 5. Leg-dominant radicular pain deemed neuropathic based on clinical history and examination. 6. Responsiveness to selective radicular nerve block with bupivacaine 0.125%. 7. Previous epidural steroid injection. Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

complex regional pain syndrome type 2 Failed Back Surgery Syndrome neuralgia post laminectomy syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic low-back pain Failed back surgery syndrome Persistent spinal pain syndrome type II Post-laminectomy syndrome

Contacts and locations

Locations

  • General Hospital Of Ciudad Real

    Ciudad Real, 13005, Spain

  • HM Monteprincipe University Hospital

    Boadilla del Monte, Madrid, 28660, Spain

  • HM Sanchinarro University Hospital

    Madrid, 28050, Spain

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

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