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 : April 7, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Low Back Pain | Device: ReActiv8 Implantable Stimulation System implanted and activated. | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 96 participants |
Allocation: | N/A |
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 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: ReActiv8 Implant |
Device: ReActiv8 Implantable Stimulation System implanted and activated. |
- 11 Point Numerical Rating Scale (NRS) for Low Back Pain [ Time Frame: 90 days ]
- Number of subjects with Adverse Events [ Time Frame: 90 days, 12 months ]
- Oswestry Disability Index [ Time Frame: 90 days ]
- Subject Global Impression of Change [ Time Frame: 90 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years, ≤65 years
- 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.
- Continuing low back pain despite >90 days of medical management
- Oswestry Disability Index score ≥25% and ≤60% at the time of enrolment
- Able to understand and sign the Informed Consent form.
- Ability to comply with the instructions for use and to operate the ReActiv8, and to comply with this Clinical Investigation Plan.
- Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
- 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:
- BMI > 35
-
Back Pain characteristics:
- Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
- Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of <10mm in subjects with lower extremity pain
- Neurological deficit possibly associated with the back pain (e.g. foot drop).
- Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
- Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia)
- 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

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
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 |
Responsible Party: | Mainstay Medical |
ClinicalTrials.gov Identifier: | NCT01985230 |
Other Study ID Numbers: |
950002 |
First Posted: | November 15, 2013 Key Record Dates |
Last Update Posted: | April 7, 2022 |
Last Verified: | April 2022 |
Back Pain Low Back Pain Pain Neurologic Manifestations |