Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReActiv8 Implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReActiv8 Implantable Stimulation System implanted and activated. | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 11 Point Numerical Rating Scale (NRS) for Low Back Pain | 90 days | |
| Number of subjects with Adverse Events | 90 days, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Global Impression of Change | 90 days |
Inclusion Criteria:
Exclusion Criteria:
BMI > 35
Back Pain characteristics:
Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
Source of pain is the sacroiliac joint as determined by the Investigator.
Drug use
Surgical and other procedures exclusions
Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion
Planned surgery.
Co-morbid chronic pain conditions
Other clinical conditions
Psycho-social exclusions
Protocol Compliance Exclusions
General exclusions
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Medicine of South Australia | Adelaide | Australia | ||||
| Hunter Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40813075 | Derived | 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. | |
| 38107760 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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. |
| 34478115 | Derived | 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. |