ReActiv8 Therapy for Chronic Lower Back Pain

(RESTORE Trial)

Not currently recruiting at 29 trial locations

Overseen By Robert Heros

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mainstay Medical

Must be taking: Optimal Medical Management

Disqualifiers: BMI > 35, Scoliosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ReActiv8, a device designed to help people with chronic lower back pain. The main goal is to compare ReActiv8 to standard treatments, such as medications and physical therapy. The trial seeks participants who have experienced lower back pain for more than six months, have not found success with other treatments, and are not candidates for spine surgery. Participants should also have back pain that impacts their daily life. This study may be a good fit for those meeting these criteria. As an unphased trial, it offers the opportunity to explore a new treatment option that could improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should be on Optimal Medical Management as determined by the Investigator. It's best to discuss your current medications with the trial team.

What prior data suggests that the ReActiv8 device is safe for treating chronic lower back pain?

Research has shown that ReActiv8 is generally well-tolerated by patients and safe for treating chronic lower back pain. One study examined its safety over three years and found that most patients did not experience serious side effects. The FDA has approved the device, confirming it meets safety standards for medical treatments. While some patients might experience mild discomfort or minor issues, no major safety concerns were reported. This makes ReActiv8 a promising option for those considering treatment for chronic lower back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

ReActiv8 is unique because it uses a novel approach to treat chronic lower back pain by targeting the root cause of the pain rather than just masking symptoms. Unlike standard treatments like medication, physical therapy, or surgery, ReActiv8 is an implantable device that stimulates specific nerves in the lower back to help restore muscle control and improve spine stability. This method offers hope for long-term relief without the side effects associated with traditional pain medications. Researchers are excited about ReActiv8 because it provides a new avenue for managing chronic pain, potentially improving the quality of life for those who haven't found success with existing treatments.

What evidence suggests that the ReActiv8 device is effective for chronic lower back pain?

Research has shown that ReActiv8 therapy effectively treats chronic lower back pain. In the ReActiv8-B trial, 83% of participants experienced significant improvements in pain and disability after three years. Studies have found that these benefits are substantial and long-lasting, with positive effects observed over five years. The treatment uses a device to strengthen the multifidus, a key back muscle, which can reduce pain. Overall, evidence suggests that ReActiv8 is a promising option for those dealing with chronic lower back pain. Participants in this trial will receive either the ReActiv8 device or optimized medical management (OMM) as a control. ^{3 4 6 7 8}

Who Is on the Research Team?

Chris Gilligan

Principal Investigator

Brigham and Women's Hospital

Kiran Patel

Principal Investigator

Northwell Health

Frank Schwab

Principal Investigator

New York-Presbyterian

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My back pain moderately affects my daily activities.

I am 21 years old or older.

I have issues with a back muscle called the lumbar multifidus.

Exclusion Criteria

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.

General exclusions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either ReActiv8 Therapy or Optimal Medical Management (OMM) for 1 year

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ReActiv8

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (ReActiv8) Active Control 1 Intervention

Market-approved ReActiv8 device

Group II: Control (OMM) Active Control 1 Intervention

Optimized medical management (OMM) (Standard of Care)

Who Is Running the Clinical Trial?

Mainstay Medical

Lead Sponsor

Trials

5

Recruited

610+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35088722/

Two-Year Results of the ReActiv8-B Pivotal Trial This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715921063868

Long-Term Outcomes of Restorative Neurostimulation in ... This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38483366/

Five-Year Longitudinal Follow-Up of Restorative ... Conclusion: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02577354

ReActiv8 Implantable Neurostimulation System for Chronic ... The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction ...

5. mainstaymedical.com mainstaymedical.com/mainstay-medical-announces-publication-of-three-year-patient-outcomes-data/

ReActiv8 -B Trial Patient Outcomes Overall, 83% of patients experienced substantial and clinically meaningful improvements in pain or disability, or both, at three years.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190021B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of the ReActiv8 System for treatment of mechanical, ...

7. mainstaymedical.com mainstaymedical.com/safety/

ReActiv8 Safety Information To view safety information for ReActiv8 Restorative Neurostimulation, please select your region. Due to differences in regulations under different ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715922012545

Three-Year Durability of Restorative Neurostimulation ... Here we report the 3-year effectiveness and safety data for this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle ...