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Spinal stimulation without tingling: a new hope for failed back surgery pain?

NCT ID NCT05169047

Disease control Sponsor: Moens Maarten 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a type of spinal cord stimulation that uses low-level electrical pulses (below the sensation threshold) against the best available medical treatments for people with ongoing back and leg pain after back surgery. About 114 participants will be randomly assigned to one of the two approaches. The goal is to see if this stimulation method leads to better overall well-being, pain relief, and function after six months.

What this could mean

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

Active substance
subthreshold spinal cord stimulation
What this could lead to
If successful, this could provide a non-drug option for managing chronic back and leg pain after failed back surgery, potentially reducing pain and improving quality of life.
What could go wrong
This is a relatively small, early-stage trial with no phase designation. The treatment may not prove more effective than standard medical care, and spinal cord stimulation carries risks like infection or device malfunction.

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

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

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: * Persistent Spinal Pain Syndrome Type II (PSPS-T2) * Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment. * PSPS-T2 patients eligible for subthreshold SCS * Age \> 18 years * Patient has been informed of the study procedures and has given written informed consent * Patient willing to comply with study protocol including attending the study visits Exclusion Criteria: * Expected inability of patients to receive or properly operate the spinal cord stimulation system * Evidence of an active psychiatric disorder * Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma). * Pregnancy

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Conditions

The condition(s) this trial relates to.

complex regional pain syndrome type 2 Failed Back Surgery Syndrome

As listed by the trial registrant

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

Failed back surgery syndrome

Contacts and locations

Locations

  • AZ Delta

    Roeselare, Belgium

  • AZ Turnhout

    Turnhout, Belgium

  • Emmaüs, AZ Sint-Maarten

    Mechelen, Belgium

  • Jessa Ziekenhuis

    Hasselt, Belgium

  • Universitair Ziekenhuis Brussel

    Jette, 1090, Belgium

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