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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
Must not have
BMI > 35
Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My BMI is over 35.
Select...
I have had surgery for scoliosis or currently have moderate to severe scoliosis.
Select...
My MRI shows a problem in my back that can be fixed with surgery.
Select...
My leg pain is worse than my back pain, or I have nerve pain below the knee.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Oswestry Disability Index (ODI)
Secondary study objectives
Change in EQ-5D
Change in Low Back Pain Numerical Rating Scale (LBP NRS)
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
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