ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

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

Official Title
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ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Device: ReActiv8


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment (ReActiv8)<br>Market-approved ReActiv8 device | Device: ReActiv8<br>* Market-approved ReActiv8 device implanted<br>|
| No Intervention: Control (OMM)<br>Standard of Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurostimulation, Stimulation, Multifidus, Restorative neurostimulation, Multifidus muscle control, Neurostimulator