ReActiv8 for Chronic Low Back Pain (PMCF) (ReActiv8-A)

May 28, 2024 updated by: Mainstay Medical

Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain

The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Pain Medicine of South Australia
      • Broadmeadow, Australia
        • Hunter Clinical Research
      • Caulfield South, Australia
        • Metro Spinal Clinic
      • Kew, Australia
        • Precision, Brain, Spine and Pain Centre
      • Noosa Heads, Australia
        • Georgius Practice
  • Belgium
      • Antwerp, Belgium
        • GZA Hospitals
      • Sint Niklaas, Belgium
        • AZ Nikolaas
  • United Kingdom
      • Basildon, United Kingdom
        • Basildon & Thurrock University Hospitals
      • Bristol, United Kingdom
        • Southmead Hospital
      • Ipswich, United Kingdom
        • Ipswich Hospital
      • Leeds, United Kingdom
        • Seacroft Hospital
      • Liverpool, United Kingdom
        • The Walton Centre
      • London, United Kingdom
        • St. Bartholomew's Hospital
      • Middlesbrough, United Kingdom
        • James Cook University Hospital
      • Southampton, United Kingdom
        • Southampton University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years, ≤65 years
  2. Chronic Low Back Pain with a first occurrence >90 days prior to enrolment, and the last relatively pain-free time >90 days prior to enrolment.
  3. Continuing low back pain despite >90 days of medical management
  4. Oswestry Disability Index score ≥25% and ≤60% at the time of enrolment
  5. Able to understand and sign the Informed Consent form.
  6. Ability to comply with the instructions for use and to operate the ReActiv8, and to comply with this Clinical Investigation Plan.
  7. Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
  8. Prior week average Low Back Pain NRS of ≥6.0 and ≤9.0 on a 11 point NRS scale (0-10) at the Baseline Visit

Exclusion Criteria:

  1. BMI > 35

  2. Back Pain characteristics:

    1. Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
    2. Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of <10mm in subjects with lower extremity pain
    3. Neurological deficit possibly associated with the back pain (e.g. foot drop).
    4. Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
    5. Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia)
  3. Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
  4. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
  5. Source of pain is the sacroiliac joint as determined by the Investigator.
  6. Drug use
  7. Surgical and other procedures exclusions
  8. Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion
  9. Planned surgery.
  10. Co-morbid chronic pain conditions
  11. Other clinical conditions
  12. Psycho-social exclusions
  13. Protocol Compliance Exclusions
  14. General exclusions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ReActiv8 Implant
Device: ReActiv8 Implantable Stimulation System implanted and activated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
11 Point Numerical Rating Scale (NRS) for Low Back Pain
Time Frame: 90 days
90 days
Number of subjects with Adverse Events
Time Frame: 90 days, 12 months
90 days, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Oswestry Disability Index
Time Frame: 90 days
90 days

Other Outcome Measures

Outcome Measure
Time Frame
Subject Global Impression of Change
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mainstay Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimated)

November 15, 2013

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 950002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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