ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
NCT ID: NCT04803214
Last Updated: 2025-12-31
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
203 participants
INTERVENTIONAL
2021-07-14
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment (ReActiv8)
Market-approved ReActiv8 device
ReActiv8
Market-approved ReActiv8 device implanted
Control (OMM)
Optimized medical management (OMM) (Standard of Care)
No interventions assigned to this group
Interventions
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ReActiv8
Market-approved ReActiv8 device implanted
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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Mainstay Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Frank Schwab
Role: STUDY_CHAIR
New York-Presbyterian
Chris Gilligan
Role: STUDY_CHAIR
Brigham and Women's Hospital
Kiran Patel
Role: STUDY_CHAIR
Northwell Health
Locations
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Barrow Brain & Spine
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
SoCal Sport and Spine
Newport Beach, California, United States
Pacific Research Institute
Santa Rosa, California, United States
University of Colorado
Aurora, Colorado, United States
International Spine, Pain and Performance Center
Washington D.C., District of Columbia, United States
Cleveland Clinic Martin Health Tradition Hospital
Port Saint Lucie, Florida, United States
Cantor Spine Center and Paley Orthopedic Spine Institute
West Palm Beach, Florida, United States
Augusta Orthopedic & Sports Medicine Specialists
Augusta, Georgia, United States
Horizon Clinical Research
Fayetteville, Georgia, United States
Vista Clinical Research
Newnan, Georgia, United States
Indiana Spine Group
Carmel, Indiana, United States
OrthoIndy
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Advent Health Shawnee Mission
Shawnee Mission, Kansas, United States
Columbia Orthopedic Group
Columbia, Missouri, United States
SSM Health Medical Group
Jefferson City, Missouri, United States
Freeman Hospital
Joplin, Missouri, United States
Northwell Health
Great Neck, New York, United States
Ainsworth Institute of Pain Management
New York, New York, United States
OrthoCarolina Sports Medicine Center
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Pacific Sports and Spine
Eugene, Oregon, United States
Spinal Diagnostics, PC
Tualatin, Oregon, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States
Countries
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References
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Gilligan C, Burnside D, Grant L, Yong RJ, Mullins PM, Schwab F, Mekhail N. ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol). Pain Ther. 2023 Apr;12(2):607-620. doi: 10.1007/s40122-023-00475-4. Epub 2023 Feb 14.
Schwab F, Mekhail N, Patel KV, Langhorst M, Heros RD, Gentile J, Costandi S, Moore G, Gilmore C, Manion S, Chakravarthy K, Meyer SC, Bundy JV, Tate JL, Sanders R, Vaid S, Szentirmai O, Goree J, Patel VV, Lehmen J, Desai MJ, Pope JE, Giuffrida A, Hayek S, Virk SS, Paicius R, Klemme WR, Levy R, Gilligan C; RESTORE investigators. Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction. Pain Ther. 2025 Feb;14(1):401-423. doi: 10.1007/s40122-024-00689-0. Epub 2025 Jan 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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980012
Identifier Type: -
Identifier Source: org_study_id