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Neurostimulation Device
ReActiv8 Therapy for Chronic Lower Back Pain (RESTORE Trial)
N/A
Waitlist Available
Research Sponsored by Mainstay Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intractable Chronic Low Back Pain that has persisted >6 months resulting in pain most of the days in the past 12 months
Not a candidate for spine surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
RESTORE Trial Summary
This trial will compare ReActiv8 Therapy to Optimal Medical Management (OMM) for treating people with Patellofemoral Pain Syndrome (PFPS).
Who is the study for?
This trial is for adults over 21 with chronic lower back pain that's severe enough to disrupt daily life but not suitable for spine surgery. Participants must have tried and failed other treatments like medications and physical therapy, have a specific disability score, and show muscle dysfunction in the lower back.Check my eligibility
What is being tested?
The study compares ReActiv8 Therapy—a device designed to stimulate muscles supporting the lumbar spine—with Optimal Medical Management (OMM), which includes various non-surgical treatments. Patients are randomly assigned to one of these two approaches.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally such devices can cause discomfort at the implant site, potential nerve or tissue damage during insertion, infection risk, and possible device malfunction.
RESTORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had chronic low back pain for more than 6 months.
Select...
I am not eligible for spine surgery.
Select...
My back pain level is between 6 and 9 on a scale of 0 to 10.
Select...
My back pain moderately affects my daily activities.
Select...
I am 21 years old or older.
Select...
I have issues with a back muscle called the lumbar multifidus.
Select...
I have had chronic low back pain for more than 6 months.
Select...
I am not eligible for spine surgery.
Select...
My back pain level is between 6 and 9 on a scale of 0 to 10.
Select...
My back pain moderately affects my daily activities.
Select...
I am willing and able to give my consent for treatment.
RESTORE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Oswestry Disability Index (ODI)
Secondary outcome measures
Change in EQ-5D
Change in Low Back Pain Numerical Rating Scale (LBP NRS)
RESTORE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment (ReActiv8)Experimental Treatment1 Intervention
Market-approved ReActiv8 device
Group II: Control (OMM)Active Control1 Intervention
Standard of Care
Find a Location
Who is running the clinical trial?
Mainstay MedicalLead Sponsor
4 Previous Clinical Trials
370 Total Patients Enrolled
Chris GilliganStudy ChairBrigham and Women's Hospital
Kiran PatelStudy ChairNorthwell Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My back pain moderately affects my daily activities.I have had surgery for scoliosis or currently have moderate to severe scoliosis.My leg pain is worse than my back pain, or I have nerve pain below the knee.I am 21 years old or older.I have issues with a back muscle called the lumbar multifidus.I have had chronic low back pain for more than 6 months.My back pain level is between 6 and 9 on a scale of 0 to 10.My back pain moderately affects my daily activities.I am willing and able to give my consent for treatment.Pain medications and physical therapy did not improve my condition.Pain medications and physical therapy did not improve my condition.My MRI shows a problem in my back that can be fixed with surgery.I am not eligible for spine surgery.I am following the best treatment plan for my condition as decided by my doctor.You should not use the ReActiv8 System.My back pain level is between 6 and 9 on a scale of 0 to 10.Exclusions related to mental and social factors.My BMI is over 35.I have no other health issues that would stop me from following the study's requirements.I have not had any surgeries that would exclude me from the trial.I have had chronic low back pain for more than 6 months.I am not eligible for spine surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ReActiv8)
- Group 2: Control (OMM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT04803214 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are involved with this experiment?
"A total of 230 eligible participants are mandated for this investigation, spearheaded by Mainstay Medical. Barrow Brain & Spine in Phoenix, Arizona and Duke University in Durham, North carolina will serve as two pivotal sites during the conduct of this trial."
Answered by AI
Is this experimental treatment being conducted in various Canadian locations?
"This clinical trial is utilizing the resources of Barrow Brain & Spine in Phoenix, Arizona; Duke University in Durham, North carolina; The Center for Clinical Research, LLC in Winston-Salem Oregon; and an additional 22 medical sites."
Answered by AI
Are volunteers able to join this exploration currently?
"Affirmative, the information on clinicaltrials.gov indicates that this study is recruiting participants at present. This medical trial was initially posted July 14th 2021 and has most recently been refreshed November 9th 2022. 230 individuals are desired to partake in this experiment across 22 sites."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
What site did they apply to?
Pacific Research Institute
University Hospitals Cleveland
OrthoIndy
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Low back pain for 30 years pain between 6-9 most times. I have been in chronic spinal pain, lower lumbar three years pretty much willing to try anything to improve my condition.
PatientReceived 2+ prior treatments
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