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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01985230
Recruitment Status : Active, not recruiting
First Posted : November 15, 2013
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mainstay Medical

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

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: ReActiv8 Implantable Stimulation System implanted and activated. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain
Study Start Date : February 2014
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: ReActiv8 Implant Device: ReActiv8 Implantable Stimulation System implanted and activated.


Outcome Measures
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Primary Outcome Measures :
  1. 11 Point Numerical Rating Scale for Low Back Pain [ Time Frame: 90 days ]
  2. Number of subjects with Adverse Events [ Time Frame: 90 days, 12 months ]

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 90 days ]

Other Outcome Measures:
  1. Subject Global Impression of Change [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985230


Locations
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Australia
Pain Medicine of South Australia
Adelaide, Australia
Hunter Clinical Research
Broadmeadow, Australia
Metro Spinal Clinic
Caulfield South, Australia
Precision, Brain, Spine and Pain Centre
Kew, Australia
Georgius Practice
Noosa Heads, Australia
Belgium
GZA Hospitals
Antwerp, Belgium
AZ Nikolaas
Sint Niklaas, Belgium
United Kingdom
Basildon & Thurrock University Hospitals
Basildon, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Seacroft Hospital
Leeds, United Kingdom
The Walton Centre
Liverpool, United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Southampton University Hospitals
Southampton, United Kingdom
Sponsors and Collaborators
Mainstay Medical
More Information
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Responsible Party: Mainstay Medical
ClinicalTrials.gov Identifier: NCT01985230     History of Changes
Other Study ID Numbers: 950002
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms