ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

Chronic Low-back Pain Clinical Trial

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Official title:

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04803214
• Other study ID #: 980012
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 14, 2021
• Est. completion date: July 2025

Study information

• Verified date: December 2023
• Source: Mainstay Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 228
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Low Back Pain

Intervention

Device:
• ReActiv8
Market-approved ReActiv8 device implanted

Locations

Country	Name	City	State
United States	Augusta Orthopedic & Sports Medicine Specialists	Augusta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Coastal Research Institute	Carlsbad	California
United States	Indiana Spine Group	Carmel	Indiana
United States	OrthoCarolina Sports Medicine Center	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	Columbia Orthopedic Group	Columbia	Missouri
United States	Duke University	Durham	North Carolina
United States	Pacific Sports and Spine	Eugene	Oregon
United States	Horizon Clinical Research	Fayetteville	Georgia
United States	Northwell Health	Great Neck	New York
United States	OrthoIndy	Indianapolis	Indiana
United States	SSM Health Medical Group	Jefferson City	Missouri
United States	Freeman Hospital	Joplin	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Center for Interventional Pain and Spine	Lancaster	Pennsylvania
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Vista Clinical Research	Newnan	Georgia
United States	Barrow Brain & Spine	Phoenix	Arizona
United States	Cleveland Clinic Martin Health Tradition Hospital	Port Saint Lucie	Florida
United States	Pacific Research Institute	Santa Rosa	California
United States	Advent Health Shawnee Mission	Shawnee Mission	Kansas
United States	Spinal Diagnostics, PC	Tualatin	Oregon
United States	International Spine, Pain and Performance Center	Washington	District of Columbia
United States	Cantor Spine Center and Paley Orthopedic Spine Institute	West Palm Beach	Florida
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mainstay Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year