Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New device offers hope for back pain sufferers who Can't go under the knife

NCT ID NCT03680846

Symptom relief Sponsor: Nevro Corp 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a device called HF10 therapy (Senza spinal cord stimulator) against standard medical care for 211 people with long-term back pain who are not candidates for surgery. The goal was to see if the device could safely reduce pain by at least 50% and improve quality of life. Participants were randomly assigned to receive either the implant or continue with usual treatments like medication and physical therapy.

What this could mean

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

Active substance
HF10 spinal cord stimulation (Senza device)
What this could lead to
If successful, this could offer a non-surgical option for people with chronic back pain who have few other choices, potentially reducing pain and improving daily function.
What could go wrong
This is a completed trial, but results may not apply to everyone. The device requires a surgical implant, which carries risks like infection or device malfunction. Pain relief may not work for all participants.

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

211 people

The number who actually took part.

Started

Sep 2018

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Key Inclusion Criteria: 1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery 2. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain 3. Qualifying pain score 4. Be on stable pain medications, as determined by the Investigator 5. Be willing and capable of giving informed consent 6. Be willing and able to comply with study-related requirements, procedures, and visits 7. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent Key Exclusion Criteria: 1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders 2. Have a medical condition or pain in other area(s), not intended to be treated in this study 3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator 4. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain 5. Have any addictions as determined by the Investigator 6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker 7. Have prior experience with neuromodulation devices 8. Other general exclusions applicable for SCS devices 9. Be involved in an injury claim under current litigation 10. Have a pending or approved worker's compensation claim

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Back pain are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Back Pain

As listed by the trial registrant

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

Back pain

Contacts and locations

Locations

  • Nevro Corp

    Redwood City, California, 94065, United States

More trials for these conditions

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