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ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

CompletedNot applicableNCT04803214
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Interventions
  • Device: ReActiv8
Sponsor
Mainstay Medical
Start date
2021-07-14
Primary completion
2024-09-04
Sex
All
Age range
from 21 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
28

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04803214