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New implant offers hope for back pain sufferers

NCT ID NCT04803214

Disease control Sponsor: Mainstay Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested an implanted device called ReActiv8 against standard medical care for chronic low-back pain. 203 adults with long-lasting pain that didn't improve with other treatments took part. The device aims to stimulate back muscles to reduce pain and improve function.

What this could mean

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

Active substance
ReActiv8 implanted device
What this could lead to
If successful, this device could offer a new option for people with chronic low-back pain who haven't found relief from other treatments.
What could go wrong
This is a completed trial, but results may not apply to everyone. The device requires surgery, which carries risks like infection or device malfunction.

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

203 people

The number who actually took part.

Started

Jul 2021

Finished

Jan 2026

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

21 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: 1. Age ≥21 years 2. Evidence of lumbar multifidus muscle dysfunction 3. Intractable Chronic Low Back Pain that has persisted \>6 months resulting in pain most of the days in the past 12 months 4. Failed therapy including pain medications and physical therapy 5. Not a candidate for spine surgery 6. Low Back Pain NRS of ≥6 and ≤9 7. Oswestry Disability Index score ≥30 and ≤60 8. Willing and capable of giving Informed Consent 9. Able to comply with this protocol 10. On Optimal Medical Management per the Investigator Exclusion Criteria: 1. Contraindicated for the ReActiv8 System 2. BMI \> 35 3. Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis 4. An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery 5. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee 6. Any condition unrelated to CLBP which, in the opinion of the Investigator, could limit physical movement or compliance with the protocol, or interfere with the assessment of efficacy 7. Surgical and other procedure exclusions 8. Psycho-social exclusions 9. Protocol compliance exclusions 10. General exclusions

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As listed by the trial registrant

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

Chronic low back pain

Contacts and locations

Locations

  • Advent Health Shawnee Mission

    Shawnee Mission, Kansas, 66204, United States

  • Ainsworth Institute of Pain Management

    New York, New York, 10022, United States

  • Augusta Orthopedic & Sports Medicine Specialists

    Augusta, Georgia, 30909, United States

  • Barrow Brain & Spine

    Phoenix, Arizona, 85013, United States

  • Cantor Spine Center and Paley Orthopedic Spine Institute

    West Palm Beach, Florida, 33407, United States

  • Center for Interventional Pain and Spine

    Lancaster, Pennsylvania, 17601, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Martin Health Tradition Hospital

    Port Saint Lucie, Florida, 34986, United States

  • Columbia Orthopedic Group

    Columbia, Missouri, 65201, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Freeman Hospital

    Joplin, Missouri, 64804, United States

  • Horizon Clinical Research

    Fayetteville, Georgia, 30214, United States

  • Indiana Spine Group

    Carmel, Indiana, 46032, United States

  • International Spine, Pain and Performance Center

    Washington D.C., District of Columbia, 20006, United States

  • Northwell Health

    Great Neck, New York, 11021, United States

  • OrthoCarolina Sports Medicine Center

    Charlotte, North Carolina, 28207, United States

  • OrthoIndy

    Indianapolis, Indiana, 46278, United States

  • Pacific Research Institute

    Santa Rosa, California, 95403, United States

  • Pacific Sports and Spine

    Eugene, Oregon, 97401, United States

  • SSM Health Medical Group

    Jefferson City, Missouri, 65109, United States

  • SoCal Sport and Spine

    Newport Beach, California, 92660, United States

  • Spinal Diagnostics, PC

    Tualatin, Oregon, 97062, United States

  • The Center for Clinical Research, LLC

    Winston-Salem, North Carolina, 27103, United States

  • University Hospitals Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Vista Clinical Research

    Newnan, Georgia, 30265, United States

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