ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation (RESTORE)

Mainstay Medical

Status: Active, not recruiting

Conditions: Chronic Low-back Pain

Treatments: Device: ReActiv8

Study type: Interventional

Funder types: Industry

Identifiers

NCT04803214

980012

Details and patient eligibility

About

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

Enrollment: 228 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Treatment (ReActiv8)

Other group

Description:

Market-approved ReActiv8 device

Treatment:

Device: ReActiv8

Control (OMM)

No Intervention group

Description:

Standard of Care