N/A
N=203
ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT04803214 ↗Enrolled (actual)
203
Serious AEs
3.9%
Results posted
Apr 2025
Primary outcome: Primary: Change in Oswestry Disability Index (ODI) — -19.7; -2.9 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ReActiv8 (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mainstay Medical
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oswestry Disability Index (ODI) |
-19.7; -2.9 | <0.001 sig |
| SECONDARY Change in Low Back Pain Numerical Rating Scale (LBP NRS) |
-3.6; -0.6 | <0.001 sig |
| SECONDARY Change in EQ-5D |
0.155; 0.008 | <0.001 sig |
Summary
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04803214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.