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This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (ReActiv8) | Active Comparator | Market-approved ReActiv8 device |
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| Control (OMM) | No Intervention | Optimized medical management (OMM) (Standard of Care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReActiv8 | Device | Market-approved ReActiv8 device implanted |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Oswestry Disability Index (ODI) | Comparison of 1-year change from baseline in ODI between Treatment and Control with MMRM for missing data. ODI is measured on a scale of 0 to 100 where a lower score is a better outcome. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low Back Pain Numerical Rating Scale (LBP NRS) | Comparison of 1-year change from baseline in LBP NRS between Treatment and Control with MMRM for missing data. NRS is measured on a scale of 0 to 10 where a higher score is a better outcome. | 1 year |
| Change in EQ-5D |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Schwab | New York-Presbyterian | Study Chair |
| Chris Gilligan | Brigham and Women's Hospital | Study Chair |
| Kiran Patel | Northwell Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Brain & Spine | Phoenix | Arizona | 85013 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36787013 | Background | 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. | |
| 39812968 |
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Of the 386 participants screened, 203 were randomized and attended at least one follow-up visit. The protocol and analysis plan required randomized patients attend at least one follow-up visit to be included in analyses.
386 participants were screened across 25 clinical sites. The first participant was enrolled in July 2021 and the last participant was enrolled in July 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (ReActiv8) | Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year Stimulation frequency: 20 Hz |
| FG001 | Control (OMM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2024 | Feb 14, 2025 |
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Comparison of 1-year change from baseline in EQ-5D between Treatment and Control with MMRM for missing data. EQ-5D is measured on a scale of -0.5 to 1.0 where a higher score is a better outcome. |
| 1 year |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| SoCal Sport and Spine | Newport Beach | California | 92660 | United States |
| Pacific Research Institute | Santa Rosa | California | 95403 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| International Spine, Pain and Performance Center | Washington D.C. | District of Columbia | 20006 | United States |
| Cleveland Clinic Martin Health Tradition Hospital | Port Saint Lucie | Florida | 34986 | United States |
| Cantor Spine Center and Paley Orthopedic Spine Institute | West Palm Beach | Florida | 33407 | United States |
| Augusta Orthopedic & Sports Medicine Specialists | Augusta | Georgia | 30909 | United States |
| Horizon Clinical Research | Fayetteville | Georgia | 30214 | United States |
| Vista Clinical Research | Newnan | Georgia | 30265 | United States |
| Indiana Spine Group | Carmel | Indiana | 46032 | United States |
| OrthoIndy | Indianapolis | Indiana | 46278 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Advent Health Shawnee Mission | Shawnee Mission | Kansas | 66204 | United States |
| Columbia Orthopedic Group | Columbia | Missouri | 65201 | United States |
| SSM Health Medical Group | Jefferson City | Missouri | 65109 | United States |
| Freeman Hospital | Joplin | Missouri | 64804 | United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | United States |
| OrthoCarolina Sports Medicine Center | Charlotte | North Carolina | 28207 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Cleveland | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Pacific Sports and Spine | Eugene | Oregon | 97401 | United States |
| Spinal Diagnostics, PC | Tualatin | Oregon | 97062 | United States |
| Center for Interventional Pain and Spine | Lancaster | Pennsylvania | 17601 | United States |
| 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. |
A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year. Optimal medical management (OMM). |
| 1.5 Month Follow up |
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| 3 Month Follow up |
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| 6 Month Follow up |
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| 12 Month Follow up |
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| COMPLETED |
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| NOT COMPLETED |
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Number of subjects who were randomized and attended at least one follow-up visit
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (ReActiv8) | Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year Stimulation frequency: 20 Hz |
| BG001 | Control (OMM) | A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | U.S. National Institutes of Health (NIH) and U.S. Office of Management and Budget (OMB) Classification Categories | Count of Participants | Participants |
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| Race (NIH/OMB) | U.S. National Institutes of Health (NIH) and U.S. Office of Management and Budget (OMB) Classification Categories | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Pain duration (years from first occurrence) | Mean | Standard Deviation | years |
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| Percent of Days with low back pain (LBP) in the last 12 months | Mean | Standard Deviation | % of days |
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| Leg pain | Count of Participants | Participants |
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| LBP NRS | Low back pain (LBP) numeric rating scale (NRS) is measured on a scale of 0 to 10 where a lower score is a better outcome. | Mean | Standard Deviation | units on a scale |
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| EQ-5D-5L index score | European Quality of Life 5-Dimensions 5 Level (EQ-5D-5L) is measured on a scale of -0.5 to 1.0 where a higher score is a better outcome. | Mean | Standard Deviation | units on a scale |
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| ODI | Oswestry Disability Index (ODI) is measured on a scale of 0 to 100 where a lower score is a better outcome. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Oswestry Disability Index (ODI) | Comparison of 1-year change from baseline in ODI between Treatment and Control with MMRM for missing data. ODI is measured on a scale of 0 to 100 where a lower score is a better outcome. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
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| Secondary | Change in Low Back Pain Numerical Rating Scale (LBP NRS) | Comparison of 1-year change from baseline in LBP NRS between Treatment and Control with MMRM for missing data. NRS is measured on a scale of 0 to 10 where a higher score is a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
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| Secondary | Change in EQ-5D | Comparison of 1-year change from baseline in EQ-5D between Treatment and Control with MMRM for missing data. EQ-5D is measured on a scale of -0.5 to 1.0 where a higher score is a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (ReActiv8) | Participants were treated with restorative neurostimulation (ReActiv8) which consists of two 30-minute stimulation sessions per day at the L2 medial branch of the dorsal ramus in addition to continued OMM through 1 year Stimulation frequency: 20 Hz | 0 | 99 | 7 | 99 | 22 | 99 |
| EG001 | Control (OMM) | A treatment plan consisting of non-investigational interventions (e.g., pharmacological agents, physical or psychosocial therapies) individualized to each patient's specific needs that was established prior to randomization through 1 year | 0 | 104 | 1 | 104 | 10 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pocket infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment | Implant site pocket infection |
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| Wound infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Aneurysm cerebral | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Appendectomy | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
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| Aseptic Meningitis | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Hemorrhagic stroke | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| Ophthalmic herpes zoster | Eye disorders | MedDRA (23.0) | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device overstimulation of tissue | Product Issues | MedDRA (23.0) | Systematic Assessment |
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| Implant site pocket pain | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
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| Back pain aggravated | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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Participants were not blinded to their treatment, and as a result, those randomized to the control arm may have experienced a nocebo effect underestimating the clinical effect of OMM. In addition, patients in the treatment arm may have experienced a placebo effect after being randomized to interventional treatment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Tinsley, Director of Clinical Affairs | Mainstay Medical | (877) 702-8488 | info@mainstaymedical.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2024 | Feb 14, 2025 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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