Clinical trial NCT04803214: ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Official title: ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Neurostimulation
Stimulation
Multifidus
Restorative neurostimulation
Multifidus muscle control
Neurostimulator
Lead sponsor: Mainstay Medical
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 203
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. All patients who satisfy the enrollment criteria are randomized (1:1) to receive either ReActiv8 (Treatment group) or OMM (Control group).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI)
timeFrame: 1 year
Secondary outcomes:
measure: Change in Low Back Pain Numerical Rating Scale (LBP NRS)
timeFrame: 1 year
measure: Change in EQ-5D
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Brain & Spine
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Newport Beach
country: United States
facility: SoCal Sport and Spine
state: California
city: Santa Rosa
country: United States
facility: Pacific Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Washington
country: United States
facility: International Spine, Pain and Performance Center
state: District of Columbia
city: Port Saint Lucie
country: United States
facility: Cleveland Clinic Martin Health Tradition Hospital
state: Florida
city: West Palm Beach
country: United States
facility: Cantor Spine Center and Paley Orthopedic Spine Institute
state: Florida
city: Augusta
country: United States
facility: Augusta Orthopedic & Sports Medicine Specialists
state: Georgia
city: Fayetteville
country: United States
facility: Horizon Clinical Research
state: Georgia
city: Newnan
country: United States
facility: Vista Clinical Research
state: Georgia
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Shawnee Mission
country: United States
facility: Advent Health Shawnee Mission
state: Kansas
city: Columbia
country: United States
facility: Columbia Orthopedic Group
state: Missouri
city: Jefferson City
country: United States
facility: SSM Health Medical Group
state: Missouri
city: Joplin
country: United States
facility: Freeman Hospital
state: Missouri
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina Sports Medicine Center
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine
state: Oregon
city: Tualatin
country: United States
facility: Spinal Diagnostics, PC
state: Oregon
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
Study officials:
affiliation: New York-Presbyterian
name: Frank Schwab
role: STUDY_CHAIR
affiliation: Brigham and Women's Hospital
name: Chris Gilligan
role: STUDY_CHAIR
affiliation: Northwell Health
name: Kiran Patel
role: STUDY_CHAIR
References:
citation: Gilligan C, Burnside D, Grant L, Yong RJ, Mullins PM, Schwab F, Mekhail N. ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol). Pain Ther. 2023 Apr;12(2):607-620. doi: 10.1007/s40122-023-00475-4. Epub 2023 Feb 14.
citation: Schwab F, Mekhail N, Patel KV, Langhorst M, Heros RD, Gentile J, Costandi S, Moore G, Gilmore C, Manion S, Chakravarthy K, Meyer SC, Bundy JV, Tate JL, Sanders R, Vaid S, Szentirmai O, Goree J, Patel VV, Lehmen J, Desai MJ, Pope JE, Giuffrida A, Hayek S, Virk SS, Paicius R, Klemme WR, Levy R, Gilligan C; RESTORE investigators. Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction. Pain Ther. 2025 Feb;14(1):401-423. doi: 10.1007/s40122-024-00689-0. Epub 2025 Jan 15.