ReActiv8 Therapy for Chronic Lower Back Pain

(RESTORE Trial)

Recruiting at 28 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

203 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment ReActiv8 for chronic lower back pain?

Research shows that the ReActiv8 treatment, which involves restorative neurostimulation, has demonstrated significant and lasting clinical benefits for patients with chronic low back pain by improving motor control and reducing pain symptoms. ^{1 2 3 4 5}

Is ReActiv8 therapy safe for humans?

The ReActiv8-B trial showed that the implanted restorative neurostimulator is safe for patients with chronic low back pain, with long-term benefits observed over several years. ^{1 3 6 7 8}

How is the ReActiv8 treatment different from other treatments for chronic lower back pain?

ReActiv8 is unique because it is an implantable device that uses restorative neurostimulation to target the lumbar multifidus muscle, helping to restore motor control and alleviate chronic low back pain. Unlike traditional treatments, it focuses on neuromuscular rehabilitation by overriding muscle inhibition, providing long-term relief for patients with mechanical back pain. ^{1 3 5 7 9}

What is the purpose of this trial?

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

Research Team

Chris Gilligan

Principal Investigator

Brigham and Women's Hospital

Kiran Patel

Principal Investigator

Northwell Health

Frank Schwab

Principal Investigator

New York-Presbyterian

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Durability of the Therapeutic Effect of Restorative Neurostimulation for Refractory Chronic Low Back Pain. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Preliminary development of a responder index for chronic low back pain. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Investigating the Mechanisms of Graded Sensorimotor Precision Training in Adults With Chronic Nonspecific Low Back Pain: Protocol for a Causal Mediation Analysis of the RESOLVE Trial. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Further qualification of a therapeutic responder index for patients with chronic low back pain. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

[Opioids in chronic low back pain. A systematic review and meta-analysis of efficacy, tolerability and safety in randomized placebo-controlled studies of at least 4 weeks duration]. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Comparative safety review of current treatment options for chronic low back pain and unmet needs: a narrative review. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Criteria for inclusion in programs of functional restoration for chronic low back pain: Pragmatic Study. [2021]