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New Pain-Free stimulator offers hope for chronic sufferers

NCT ID NCT04618471

Symptom relief Sponsor: Boston Scientific Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 6 times

Summary

This study tests a spinal cord stimulator that delivers fast-acting pain relief without the usual tingling sensation. About 177 adults with long-term back and limb pain will use the device. The main goal is to see if at least half of them get 50% or more pain reduction after 3 months.

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

177 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Mar 2029

An estimate. End dates often move.

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

22 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: * Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain. * 22 years of age or older when written informed consent is obtained * Able to independently read and complete all questionnaires and assessments provided in English * Signed a valid, IRB-approved informed consent form (ICF) provided in English Key Exclusion Criteria: * Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes * Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study * Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception * Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome

As listed by the trial registrant

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

Chronic pain

Contacts and locations

Locations

  • Acute and Chronic Pain Therapies

    Bellevue, Washington, 98005, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Denver Back Pain Specialists

    Greenwood Village, Colorado, 80111, United States

  • Goodman Campbell Brain and Spine

    Carmel, Indiana, 46032, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Orlando Health Neuroscience Institute

    Clermont, Florida, 34711, United States

  • PCPMG Clinical Research Unit, LLC

    Greenville, South Carolina, 29601, United States

  • Pacific Sports and Spine, LLC

    Eugene, Oregon, 97401, United States

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103, United States

  • The Orthopaedic Institute

    Gainesville, Florida, 32607, United States

  • University of Chicago Hospital

    Chicago, Illinois, 60637, United States

  • Vitamed Research

    Palm Desert, California, 92260, United States

  • Willis-Knighton River Cities Clinical Research Center

    Shreveport, Louisiana, 71105, United States

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