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Spinal implant plus exercise may ease back pain after failed surgery

NCT ID NCT06272539

Symptom relief Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study investigates whether combining spinal cord stimulation with a specific exercise program can reduce pain and improve quality of life in people with persistent back pain after surgery (failed back surgery syndrome). Participants will be randomly assigned to receive either the combined treatment or exercise alone over 8 weeks. The goal is to see if the combination offers better relief than exercise by itself.

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 and exercise program
What this could lead to
If successful, this combination approach could offer a better way to manage chronic back pain and disability after failed surgery.
What could go wrong
This is a small, early-stage trial with only 36 participants, so results may not apply widely. There is also a risk of electrode migration during exercise.

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

36 people

The number who actually took part.

Started

Apr 2024

Finished

Jun 2026

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 80 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: * Have a diagnostic of PSPS-T1/2 with leg pain and back pain, * Patients older than 18 years * 6 months with pain * Visual Analogue Scale score \>7 * Spanish native language Exclusion Criteria: * Previous surgeries in abdominal area * Pregnant or lactating * Severe fractures or pathologies * Spine structural deformity * Neurologic or psychiatric issues.

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Conditions

The condition(s) this trial relates to.

complex regional pain syndrome type 1 complex regional pain syndrome type 2 Failed Back Surgery Syndrome Motor Activity

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

  • Juan Vicente-Mampel

    Torrent, Valencia, 46900, Spain

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