What side effects are associated with this type of intervention?

Common treatments for chronic lower back pain using neuromodulation and nerve stimulation, such as spinal cord stimulation (SCS) and transcutaneous electrical nerve stimulation (TENS), can have side effects including increased pain, transient lower limb numbness, paraesthesias, superficial burns, and device-related issues like lead migration or mechanical failures. Mild adverse events for other neuromodulation devices may include sensations of warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain. Serious adverse events are rare but can include infections and, in very rare cases, neurological injury.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of chronic lower back pain, including spinal cord stimulators (SCS). These devices work by delivering electrical impulses to the spinal cord to modulate pain signals before they reach the brain. Examples of FDA-approved spinal cord stimulators include devices from companies like Medtronic, Boston Scientific, and Nevro. These treatments are typically considered for patients who have not responded to conventional medical management and are designed to provide long-term pain relief by altering nerve activity.

What other types of research exist?

Promising alternatives to ReActiv8 for chronic lower back pain include: 1) Spinal Cord Stimulation (SCS) with high-frequency (10-kHz) devices, which have shown efficacy in randomized clinical trials. 2) Burst Stimulation, as evidenced by the SUNBURST study, which offers both traditional tonic and burst stimulation modes. 3) Dorsal Nerve Root Stimulation, which has been evaluated in open-label, prospective studies for chronic pain management.

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ReActiv8 Neurostimulation for Chronic Lower Back Pain (ReActiv8-B 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

Age ≥22 years, ≤75 years

Be older than 18 years old

Must not have

Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion that is amenable to surgery

Back pain due to vascular causes such as aortic aneurysm and dissection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ReActiv8, a device that helps reduce chronic low back pain by stimulating muscles in the lower back. It is aimed at adults who have long-term back pain that isn't fully managed by regular treatments. The device works by sending electrical signals to strengthen the muscles supporting the spine. Previous tests have documented its long-term benefits for chronic low back pain.

Who is the study for?

This trial is for adults aged 22 to 75 with chronic low back pain lasting over 90 days despite medical treatment. Participants must have a qualifying pain score, evidence of lumbar muscle dysfunction, and be able to give informed consent and follow the study plan. Exclusions include drug use, certain surgical histories, worse leg than back pain, planned surgeries, BMI over 35, spinal conditions like stenosis or neurological deficits.

What is being tested?

The ReActiv8 Implantable Neurostimulation System is being tested in this trial. It involves two levels of stimulation: low and patient-appropriate. The goal is to assess how safe and effective ReActiv8 is alongside usual medical care for treating chronic lower back pain.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, possible nerve or tissue damage from the implant procedure itself, infection risks associated with surgery or implants, changes in back pain sensation due to stimulation adjustments.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a lower back injury that can be treated with surgery.

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My back pain is caused by issues with my blood vessels.

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I need back surgery according to guidelines or cannot have it for other reasons.

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My back pain is caused by conditions like endometriosis, fibroids, or infections.

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I have a narrow spinal canal in my lower back causing leg pain.

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I have had surgery for scoliosis or currently have scoliosis.

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I have back pain because of spinal cord inflammation or damage.

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I have not had any recent surgeries or procedures.

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My leg pain is worse than my back pain, or I have nerve pain below the knee.

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My BMI is over 35.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels

Mean Change in Low Back Pain VAS

Responder Rate of Low Back Pain With No Increase in Pain Medications

+1 more

Secondary study objectives

Change in European Quality of Life Score on Five Dimensions (EQ-5D)

Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year

Change in Oswestry Disability Index (ODI)

+9 more

Other study objectives

Change in Opioid Use for Treatment of Low Back Pain at One-Year

Clinical Global Impression of Change

Clinical Global Impression of Change at One Year

+3 more

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

Group I: TreatmentExperimental Treatment1 Intervention

Group II: ControlExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ReActiv8 Implantable Stimulation System (Low Stimulation)

2016

N/A

~210

ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)

2016

N/A

~210

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neuromodulation devices, such as spinal cord stimulators and the ReActiv8 system, work by delivering electrical impulses to the spinal cord or peripheral nerves to alter pain signals before they reach the brain, providing significant pain relief. Other common treatments for Chronic Lower Back Pain (CLBP) include NSAIDs and muscle relaxants, which reduce inflammation and muscle spasms, and exercise therapy, which strengthens the muscles supporting the spine and improves flexibility. Understanding these mechanisms helps CLBP patients make informed decisions about their treatment options and manage their expectations regarding pain relief and functional improvement.