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Purpose

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

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Treatment (ReActiv8) 		Market-approved ReActiv8 device
  • Device: ReActiv8
    Market-approved ReActiv8 device implanted
No Intervention
Control (OMM) 		Standard of Care

Recruiting Locations

More Details

NCT ID
NCT04803214
Status
Active, not recruiting
Sponsor
Mainstay Medical

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.