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Can a 'Paresthesia-Free' implant ease Post-Surgery leg pain?

NCT ID NCT05372822

Symptom relief Sponsor: St. Olavs 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This trial tests whether burst spinal cord stimulation, a type of implanted device that delivers high-frequency electrical pulses, can reduce chronic leg pain that persists after lumbar spine surgery. Participants, who have had pain for at least six months despite other treatments, will receive both burst stimulation and a sham (inactive) stimulation in a random order to compare effects. The study measures changes in disability, pain levels, and quality of life to see if this approach offers relief without the tingling sensation typical of standard spinal cord stimulation.

What this could mean

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

Active substance
Burst spinal cord stimulation, a procedure using an implanted device that delivers high-frequency electrical pulses to the spinal cord, compared to sham (inactive) stimulation.
What this could lead to
If effective, this could offer a new, paresthesia-free option for people with persistent leg pain after back surgery, potentially improving function and quality of life.
What could go wrong
This is a relatively small trial, and the effect may vary. The procedure requires surgery to implant a device, which carries risks like infection or device-related complications.

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

40 people

The number who actually took part.

Started

May 2021

Expected to finish

Dec 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: * Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months * Minimum pain intensity of 5/10 on the leg pain NRS at baseline * Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period * Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital * Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period Exclusion Criteria: * Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy) * History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed. * Abnormal pain behavior and/or unresolved psychiatric illness. * Unresolved issues of secondary gain or inappropriate medication use.

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Conditions

The condition(s) this trial relates to.

Back Pain Pain, Postoperative

As listed by the trial registrant

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

Back pain with radiation Pain, postoperative

Contacts and locations

Locations

  • St Olavs Hospital

    Trondheim, Norway

More trials for these conditions

Other studies related to the condition(s) this trial covers.