Neurostimulation Device

Treatment (ReActiv8) for Chronic Lower Back Pain

SSM Health Medical Group, Jefferson City, MO

ReActiv8N/ARecruitingResearch Sponsored by Mainstay Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low Back Pain NRS of ≥6 and ≤9

Intractable Chronic Low Back Pain that has persisted >6 months resulting in pain most of the days in the past 12 months

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up1 year

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will compare ReActiv8 Therapy to Optimal Medical Management (OMM) for treating people with Patellofemoral Pain Syndrome (PFPS).

Eligible Conditions

Chronic Lower Back Pain

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You are experiencing low back pain that ranges from moderate to severe, with a rating of 6 to 9 on a pain scale.

Select...

You have had constant and severe low back pain for more than 6 months, and it has caused you pain on most days in the last year.

Select...

You have tried pain medications and physical therapy, but they did not work.

Select...

You cannot have surgery on your spine.

Select...

You have a moderate level of disability based on your Oswestry Disability Index score, which is between 30 and 60.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met

Find a site

Who is running the clinical trial?

Mainstay MedicalLead Sponsor

4 Previous Clinical Trials

370 Total Patients Enrolled

Frank SchwabStudy Chair

New York-Presbyterian

Media Library

ReActiv8 (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04803214 — N/A

Chronic Lower Back Pain Research Study Groups: Treatment (ReActiv8), Control (OMM)

Chronic Lower Back Pain Clinical Trial 2023: ReActiv8 Highlights & Side Effects. Trial Name: NCT04803214 — N/A

ReActiv8 (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04803214 — N/A

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

Cleveland Clinic Martin Health Tradition Hospital

Cantor Spine Center and Paley Orthopedic Spine Institute

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

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.

Patient

Recent research and studies

clinicaltrials.govStudy

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

2021. "ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04803214.