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

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ClinicalTrials.gov Identifier: NCT04803214
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Mainstay Medical

Study Description
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Brief Summary:
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Device: ReActiv8 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Treatment (ReActiv8)
Market-approved ReActiv8 device
 Device: ReActiv8
Market-approved ReActiv8 device implanted
No Intervention: Control (OMM)
Standard of Care


Outcome Measures
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Primary Outcome Measures :
  1. Change in Oswestry Disability Index (ODI) [ Time Frame: 1 year ]
    Comparison of 1-year change from baseline in ODI between Treatment and Control. ODI is measured on a scale of 0 to 100 where a higher score is a better outcome.


Secondary Outcome Measures :
  1. 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.

    NRS is measured on a scale of 0 to 10 where a higher score is a better outcome.


  2. Change in EQ-5D [ Time Frame: 1 year ]

    Comparison of 1-year change from baseline in EQ-5D between Treatment and Control.

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



Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803214


Contacts
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Contact: Diane Burnside 763-270-5303 diane.burnside@mainstay-medical.com

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Susan Smith Dodson    501-526-7906    dodsonsusansmith@uams.edu   
Principal Investigator: Johnathan Goree         
United States, California
Pacific Research Institute Recruiting
Santa Rosa, California, United States, 95403
Contact: Katey Marin    707-321-8647    research@erc.care   
Principal Investigator: Jason Pope         
United States, District of Columbia
International Spine, Pain and Performance Center Recruiting
Washington, District of Columbia, United States, 20006
Contact: Evelynne Morris    202-808-8295    emorris@isppcenter.com   
Principal Investigator: Mehul Desai         
United States, Georgia
Augusta Orthopedic & Sports Medicine Specialists Recruiting
Augusta, Georgia, United States, 30909
Contact: Tina Martin    706-863-9797 ext 214    tinam@ortho-augusta.com   
Principal Investigator: Justin Bundy         
United States, Indiana
Indiana Spine Group Recruiting
Carmel, Indiana, United States, 46032
Contact: Sheetal Vinayek    317-715-5897    svinayek@indianaspinegroup.com   
Principal Investigator: Jonathan Gentile         
OrthoIndy Recruiting
Indianapolis, Indiana, United States, 46278
Contact: Melanie Glover    317-802-2880    mglover@orthoindy.com   
Principal Investigator: Meredith Langhorst         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Rachel Henning    913-945-8072    rhenning2@kumc.edu   
Principal Investigator: Dawood Sayed         
United States, Missouri
SSM Health Medical Group Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Terry Perrago    573-291-4463    terry.perrago@ssmhealth.com   
Principal Investigator: Jeff Lehmen         
United States, North Carolina
OrthoCarolina Sports Medicine Center Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Najma Mohamed    704-323-3653    Najma.Mohamed@orthocarolina.com   
Principal Investigator: Bradley Segebarth         
The Center for Clinical Research, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Lisa Boles    336-765-6181 ext 136    lboles@ccrpain.com   
Principal Investigator: Christopher Gilmore         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter Yassa    216-445-5132    Yassap@ccf.org   
Principal Investigator: Shrif Costandi         
United States, Oregon
Pacific Sports and Spine Recruiting
Eugene, Oregon, United States, 97401
Contact: Evan Doll    571-284-0530    edoll@pacificsportsandspine.com   
Principal Investigator: Greg Moore         
Spinal Diagnostics, PC Recruiting
Tualatin, Oregon, United States, 97062
Contact: Evelyn Strickler    503-885-1515    evelyns@spinaldx.com   
Principal Investigator: Robert Heros         
United States, Pennsylvania
Center for Interventional Pain and Spine Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Ashley Scherer    844-365-7246    ashleys@centerisp.com   
Principal Investigator: Michael Fishman         
Sponsors and Collaborators
Mainstay Medical
Investigators
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Study Chair: Frank Schwab New York-Presbyterian
More Information
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Responsible Party: Mainstay Medical
ClinicalTrials.gov Identifier: NCT04803214    
Other Study ID Numbers: 980012
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mainstay Medical:
Neurostimulation
Stimulation
Multifidus
 Restorative neurostimulation
Multifidus muscle control
Neurostimulator
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations