Trial record 2 of 6 for:
mainstay restore
ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation (RESTORE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04803214 |
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Recruitment Status :
Recruiting
First Posted : March 17, 2021
Last Update Posted : May 6, 2023
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Sponsor:
Mainstay Medical
Information provided by (Responsible Party):
Mainstay Medical
- Study Details
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Brief Summary:
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Low-back Pain | Device: ReActiv8 | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation |
| Actual Study Start Date : | July 14, 2021 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | July 2025 |
| Arm | Intervention/treatment |
|---|---|
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Treatment (ReActiv8)
Market-approved ReActiv8 device
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Device: ReActiv8
Market-approved ReActiv8 device implanted |
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No Intervention: Control (OMM)
Standard of Care
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Primary Outcome Measures :
- Change in Oswestry Disability Index (ODI) [ Time Frame: 1 year ]Comparison of 1-year change from baseline in ODI between Treatment and Control. ODI is measured on a scale of 0 to 100 where a higher score is a better outcome.
Secondary Outcome Measures :
- Change in Low Back Pain Numerical Rating Scale (LBP NRS) [ Time Frame: 1 year ]
Comparison of 1-year change from baseline in LBP NRS between Treatment and Control.
NRS is measured on a scale of 0 to 10 where a higher score is a better outcome.
- Change in EQ-5D [ Time Frame: 1 year ]
Comparison of 1-year change from baseline in EQ-5D between Treatment and Control.
EQ-5D is measured on a scale of -0.5 to 1.0 where a higher score is a better outcome.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803214
Contacts
| Contact: Diane Burnside | 763-270-5303 | diane.burnside@mainstay-medical.com |
Locations
Show 28 study locations
Sponsors and Collaborators
Mainstay Medical
Investigators
| Study Chair: | Frank Schwab | New York-Presbyterian |
| Responsible Party: | Mainstay Medical |
| ClinicalTrials.gov Identifier: | NCT04803214 |
| Other Study ID Numbers: |
980012 |
| First Posted: | March 17, 2021 Key Record Dates |
| Last Update Posted: | May 6, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Mainstay Medical:
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Neurostimulation Stimulation Multifidus |
Restorative neurostimulation Multifidus muscle control Neurostimulator |
Additional relevant MeSH terms:
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Low Back Pain Back Pain Pain Neurologic Manifestations |