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Spinal cord stimulator put to the test against sham for post-surgery leg pain

NCT ID NCT06585033

Symptom relief Sponsor: Sahlgrenska University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a spinal cord stimulator can reduce long-term leg pain in people who still have pain after lumbar spine surgery. Fifty adults aged 18-70 who have not improved with other treatments will receive either active stimulation or sham (no stimulation) for 3 months each, without knowing which they are getting. The goal is to see if active stimulation provides better pain relief and improves quality of life.

What this could mean

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

Active substance
spinal cord stimulation device
What this could lead to
If it works, this could confirm that spinal cord stimulation is an effective long-term treatment for stubborn leg pain after back surgery.
What could go wrong
This is a relatively small, early-stage trial. A recent similar study found no difference between active and sham stimulation, so results may not be clear-cut.

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 50 people

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

Started

Nov 2024

Expected to finish

Jun 2027

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 to 70 years

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: * History consistent with PSPS2 of at least 6 months after the last spinal surgery. The patient experienced no effect of conservative treatments and has been assessed as not eligible for further spinal surgery. * Patients between 18-70 years of age. * Average perceived pain intensity in one or both legs of 5 or more and average perceived pain intensity in the back of less than 3 measured with the validated 11-box NRS (0 no pain, 10 worst imaginable pain) * The patient should have been informed verbally and in writing about the study and should have provided informed written consent to participate. * Adequate pain relief effect (50% or more) after a two week trial with active test stimulation. Exclusion Criteria: * Subject is unable to understand or operate the SCS device. * Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system. * Ongoing coagulation disorder. * Ongoing abuse of alcohol, drugs, or prescription opioids. * Active debilitating psychiatric illness. * Active malignancy. * Condition with increased general infection sensitivity, such as known immunodeficiency. * Expected lifespan \<1 year. * Ongoing local infection or other skin disease where the IPG is planned to be placed. * Pregnancy.

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Conditions

The condition(s) this trial relates to.

Chronic Pain complex regional pain syndrome type 2 Pain, Postoperative

As listed by the trial registrant

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

Chronic postoperative pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Anaesthesiology and Pain Management, Rijnstate Hospital

    RECRUITING

    Arnhem, 6800, Netherlands

  • Department of Anesthesiology and Intensive Care/Pain Center, Sahlgrenska University Hospital Östra

    RECRUITING

    Gothenburg, 41650, Sweden

  • Department of Neurosurgery, Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 41257, Sweden

  • Department of Neurosurgery, Stavanger University hospital

    RECRUITING

    Stavanger, 4019, Norway

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