This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. All patients who satisfy the enrollment criteria are randomized (1:1) to receive either ReActiv8 (Treatment group) or OMM (Control group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
203
Market-approved ReActiv8 device implanted
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.
Time frame: 1 year
Change in Low Back Pain Numerical Rating Scale (LBP NRS)
Comparison of 1-year change from baseline in LBP NRS between Treatment and Control with MMRM for missing data. NRS is measured on a scale of 0 to 10 where a higher score is a better outcome.
Time frame: 1 year
Change in EQ-5D
Comparison of 1-year change from baseline in EQ-5D between Treatment and Control with MMRM for missing data. 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 18 more locations