ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

Not Applicable

Active, not recruiting

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

Detailed Description: 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).

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index (ODI)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Change in Low Back Pain Numerical Rating Scale (LBP NRS)	1 year	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.
Change in EQ-5D	1 year	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.

Locations (28): SoCal Sport and Spine
🇺🇸
Newport Beach, California, United States
Barrow Brain & Spine
🇺🇸
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Pacific Research Institute
🇺🇸
Santa Rosa, California, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
International Spine, Pain and Performance Center
🇺🇸
Washington, 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
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SoCal Sport and Spine
🇺🇸Newport Beach, California, United States