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

Primary Purpose

Chronic Low-back Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReActiv8
Sponsored by
Mainstay Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Neurostimulation, Stimulation, Multifidus, Restorative neurostimulation, Multifidus muscle control, Neurostimulator

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Brain & Spine
  • University of Arkansas for Medical Sciences
  • Coastal Research Institute
  • Pacific Research Institute
  • University of Colorado
  • International Spine, Pain and Performance Center
  • Cleveland Clinic Martin Health Tradition Hospital
  • Cantor Spine Center and Paley Orthopedic Spine Institute
  • Augusta Orthopedic & Sports Medicine Specialists
  • Horizon Clinical Research
  • Vista Clinical Research
  • Indiana Spine Group
  • OrthoIndy
  • University of Kansas Medical Center
  • Advent Health Shawnee Mission
  • Columbia Orthopedic Group
  • SSM Health Medical Group
  • Freeman Hospital
  • Northwell Health
  • Ainsworth Institute of Pain Management
  • OrthoCarolina Sports Medicine Center
  • Duke University
  • The Center for Clinical Research, LLC
  • University Hospitals Cleveland
  • Cleveland Clinic
  • Pacific Sports and Spine
  • Spinal Diagnostics, PC
  • Center for Interventional Pain and Spine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Treatment (ReActiv8)

Control (OMM)

Arm Description

Market-approved ReActiv8 device

Standard of Care

Outcomes

Primary Outcome Measures

Change in Oswestry Disability Index (ODI)
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

Change in Low Back Pain Numerical Rating Scale (LBP NRS)
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.
Change in EQ-5D
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.

Full Information

First Posted
March 14, 2021
Last Updated
October 17, 2023
Sponsor
Mainstay Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04803214
Brief Title
ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Acronym
RESTORE
Official Title
ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mainstay Medical

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Neurostimulation, Stimulation, Multifidus, Restorative neurostimulation, Multifidus muscle control, Neurostimulator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (ReActiv8)
Arm Type
Other
Arm Description
Market-approved ReActiv8 device
Arm Title
Control (OMM)
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
ReActiv8
Intervention Description
Market-approved ReActiv8 device implanted
Primary Outcome Measure Information:
Title
Change in Oswestry Disability Index (ODI)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Low Back Pain Numerical Rating Scale (LBP NRS)
Description
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.
Time Frame
1 year
Title
Change in EQ-5D
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Surgical and other procedure exclusions Psycho-social exclusions Protocol compliance exclusions General exclusions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Schwab
Organizational Affiliation
New York-Presbyterian
Official's Role
Study Chair
Facility Information:
Facility Name
Barrow Brain & Spine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Coastal Research Institute
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Pacific Research Institute
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
International Spine, Pain and Performance Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Facility Name
Cleveland Clinic Martin Health Tradition Hospital
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34986
Country
United States
Facility Name
Cantor Spine Center and Paley Orthopedic Spine Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Augusta Orthopedic & Sports Medicine Specialists
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Horizon Clinical Research
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Vista Clinical Research
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
OrthoIndy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46278
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Advent Health Shawnee Mission
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Columbia Orthopedic Group
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
SSM Health Medical Group
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Freeman Hospital
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Ainsworth Institute of Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
OrthoCarolina Sports Medicine Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pacific Sports and Spine
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Spinal Diagnostics, PC
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Center for Interventional Pain and Spine
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

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