ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

NCT04803214 | Completed Results FDA Device

• 1 other identifier: 980012
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 28

Brief Summary

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

Conditions

Chronic Low-back Pain

Keywords

Neurostimulation; Stimulation; Multifidus; Restorative neurostimulation; Multifidus muscle control; Neurostimulator

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index (ODI)

  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 Outcomes (2)

• Change in Low Back Pain Numerical Rating Scale (LBP NRS)

  1 year

• Change in EQ-5D

  1 year

Study Arms (2)

Treatment (ReActiv8)

ACTIVE COMPARATOR

Market-approved ReActiv8 device

Device: ReActiv8

Control (OMM)

NO INTERVENTION

Optimized medical management (OMM) (Standard of Care)

Interventions

ReActiv8 DEVICE

Market-approved ReActiv8 device implanted

Treatment (ReActiv8)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥21 years
• Evidence of lumbar multifidus muscle dysfunction
• Intractable Chronic Low Back Pain that has persisted \>6 months resulting in pain most of the days in the past 12 months
• Failed therapy including pain medications and physical therapy
• Not a candidate for spine surgery
• Low Back Pain NRS of ≥6 and ≤9
• Oswestry Disability Index score ≥30 and ≤60
• Willing and capable of giving Informed Consent
• Able to comply with this protocol
• On Optimal Medical Management per the Investigator

You may not qualify if:

• Contraindicated for the ReActiv8 System
• BMI \> 35
• Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis
• An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery
• Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee
• 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

Sponsors & Collaborators

• Mainstay Medical: lead

Study Sites (28)

Barrow Brain & Spine

Phoenix, Arizona, 85013, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

SoCal Sport and Spine

Newport Beach, California, 92660, United States

Location

Pacific Research Institute

Santa Rosa, California, 95403, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

International Spine, Pain and Performance Center

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

Location

Cleveland Clinic Martin Health Tradition Hospital

Port Saint Lucie, Florida, 34986, United States

Location

Cantor Spine Center and Paley Orthopedic Spine Institute

West Palm Beach, Florida, 33407, United States

Location

Augusta Orthopedic & Sports Medicine Specialists

Augusta, Georgia, 30909, United States

Location

Horizon Clinical Research

Fayetteville, Georgia, 30214, United States

Location

Vista Clinical Research

Newnan, Georgia, 30265, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

OrthoIndy

Indianapolis, Indiana, 46278, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Advent Health Shawnee Mission

Shawnee Mission, Kansas, 66204, United States

Location

Columbia Orthopedic Group

Columbia, Missouri, 65201, United States

Location

SSM Health Medical Group

Jefferson City, Missouri, 65109, United States

Location

Freeman Hospital

Joplin, Missouri, 64804, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

OrthoCarolina Sports Medicine Center

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Pacific Sports and Spine

Eugene, Oregon, 97401, United States

Location

Spinal Diagnostics, PC

Tualatin, Oregon, 97062, United States

Location

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, 17601, United States

Location

Related Publications (2)

• 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.

  PMID: 36787013 BACKGROUND

• 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.

  PMID: 39812968 RESULT

Limitations and Caveats

Participants were not blinded to their treatment, and as a result, those randomized to the control arm may have experienced a nocebo effect underestimating the clinical effect of OMM. In addition, patients in the treatment arm may have experienced a placebo effect after being randomized to interventional treatment.

Results Point of Contact

• Title: Jennifer Tinsley, Director of Clinical Affairs
• Organization: Mainstay Medical

info@mainstaymedical.com

(877) 702-8488

Study Officials

• Frank Schwab

  New York-Presbyterian

  STUDY CHAIR

• Chris Gilligan

  Brigham and Women's Hospital

  STUDY CHAIR

• Kiran Patel

  Northwell Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 17, 2021
• Study Start: July 14, 2021
• Primary Completion: September 4, 2024
• Study Completion: January 5, 2026
• Last Updated: January 23, 2026
• Results First Posted: April 13, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)