ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation (RESTORE)

January 5, 2026 updated by: Mainstay Medical
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. All patients who satisfy the enrollment criteria are randomized (1:1) to receive either ReActiv8 (Treatment group) or OMM (Control group).

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Brain & Spine
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Newport Beach, California, United States, 92660
        • SoCal Sport and Spine
      • Santa Rosa, California, United States, 95403
        • Pacific Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20006
        • International Spine, Pain and Performance Center
    • Florida
      • Port Saint Lucie, Florida, United States, 34986
        • Cleveland Clinic Martin Health Tradition Hospital
      • West Palm Beach, Florida, United States, 33407
        • Cantor Spine Center and Paley Orthopedic Spine Institute
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Augusta Orthopedic & Sports Medicine Specialists
      • Fayetteville, Georgia, United States, 30214
        • Horizon Clinical Research
      • Newnan, Georgia, United States, 30265
        • Vista Clinical Research
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Indiana Spine Group
      • Indianapolis, Indiana, United States, 46278
        • OrthoIndy
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Shawnee Mission, Kansas, United States, 66204
        • Advent Health Shawnee Mission
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Columbia Orthopedic Group
      • Jefferson City, Missouri, United States, 65109
        • SSM Health Medical Group
      • Joplin, Missouri, United States, 64804
        • Freeman Hospital
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • New York, New York, United States, 10022
        • Ainsworth Institute of Pain Management
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Sports Medicine Center
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Sports and Spine
      • Tualatin, Oregon, United States, 97062
        • Spinal Diagnostics, PC
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Center for Interventional Pain and Spine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment (ReActiv8)
Market-approved ReActiv8 device
Device: ReActiv8
Market-approved ReActiv8 device implanted
No Intervention: Control (OMM)
Optimized medical management (OMM) (Standard of Care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oswestry Disability Index (ODI)
Time Frame: 1 year

Comparison of 1-year change from baseline in ODI between Treatment and Control with MMRM for missing data.

ODI is measured on a scale of 0 to 100 where a lower score is a better outcome.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Low Back Pain Numerical Rating Scale (LBP NRS)
Time Frame: 1 year

Comparison of 1-year change from baseline in LBP NRS between Treatment and Control with MMRM for missing data.

NRS is measured on a scale of 0 to 10 where a higher score is a better outcome.
1 year
Change in EQ-5D
Time Frame: 1 year

Comparison of 1-year change from baseline in EQ-5D between Treatment and Control with MMRM for missing data.

EQ-5D is measured on a scale of -0.5 to 1.0 where a higher score is a better outcome.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mainstay Medical

Investigators

  • Study Chair: Frank Schwab, New York-Presbyterian
  • Study Chair: Chris Gilligan, Brigham and Women's Hospital
  • Study Chair: Kiran Patel, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2021

Primary Completion (Actual)

September 4, 2024

Study Completion (Actual)

January 5, 2026

Study Registration Dates

First Submitted

March 14, 2021

First Submitted That Met QC Criteria

March 14, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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