ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Purpose
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).
Condition
- Chronic Low-back Pain
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Other Treatment (ReActiv8) |
Market-approved ReActiv8 device |
|
No Intervention Control (OMM) |
Standard of Care |
|
Recruiting Locations
More Details
- NCT ID
- NCT04803214
- Status
- Active, not recruiting
- Sponsor
- Mainstay Medical