Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2014-02-28
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ReActiv8 Implant
ReActiv8 Implantable Stimulation System implanted and activated.
Interventions
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ReActiv8 Implantable Stimulation System implanted and activated.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Mainstay Medical
INDUSTRY
Responsible Party
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Locations
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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, , Australia
GZA Hospitals
Antwerp, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
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
Countries
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References
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Thomson S, Williams A, Vajramani G, Sharma M, Love-Jones S, Chawla R, Eldabe S. 5-year longitudinal follow-up of patients treated for chronic mechanical low back pain using restorative neurostimulation. Reg Anesth Pain Med. 2025 Aug 14:rapm-2025-106899. doi: 10.1136/rapm-2025-106899. Online ahead of print.
Thomson S, Williams A, Vajramani G, Sharma M, Love-Jones S, Chawla R, Eldabe S. Restorative neurostimulation for chronic mechanical low back pain - Three year results from the United Kingdom post market clinical follow-up registry. Br J Pain. 2023 Oct;17(5):447-456. doi: 10.1177/20494637231181498. Epub 2023 Jun 6.
Thomson S, Chawla R, Love-Jones S, Sharma M, Vajramani G, Williams A, Eldabe S; ReActiv8 PMCF Investigators. Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort. Pain Ther. 2021 Dec;10(2):1451-1465. doi: 10.1007/s40122-021-00307-3. Epub 2021 Sep 3.
Other Identifiers
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950002
Identifier Type: -
Identifier Source: org_study_id
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