Chronic Low Back PainReActiv8-ANCT01985230
ReActiv8 for Chronic Low Back Pain (PMCF)
A study testing ReActiv8 Implantable Stimulation System implanted and activated. in people with Chronic Low Back Pain, run by Mainstay Medical at 15 sites in 3 countries.
Trial summary
The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- ReActiv8 Implantable Stimulation System implanted and activated.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Feb 2014to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 19Show fewer
- 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
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United Kingdom8 sites
Basildon & Thurrock University Hospitals
Basildon
Southmead Hospital
Bristol
Ipswich Hospital
Ipswich
Seacroft Hospital
Leeds
The Walton Centre
Liverpool
St. Bartholomew's Hospital
London
James Cook University Hospital
Middlesbrough
Southampton University Hospitals
Southampton
Australia5 sites
Pain Medicine of South Australia
Adelaide
Hunter Clinical Research
Broadmeadow
Metro Spinal Clinic
Caulfield South
Precision, Brain, Spine and Pain Centre
Kew
Georgius Practice
Noosa
About this study
Official title: 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- ReActiv8 Implantable Stimulation System implanted and activated.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReActiv8 Implantable Stimulation System implanted and activated.Device
| Study group | Role | What they receive |
|---|---|---|
| ReActiv8 Implant | Experimental | Not described Receives: Device: ReActiv8 Implantable Stimulation System implanted and activated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
11 Point Numerical Rating Scale (NRS) for Low Back Pain
Measured: 90 days
Number of subjects with Adverse Events
Measured: 90 days, 12 months
Secondary outcomes (1)
Oswestry Disability Index
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mainstay Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985230
- Sponsor's protocol ID
- 950002
- Acronym
- ReActiv8-A
- Status last verified
- May 2024
- First submitted
- 5 Nov 2013
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40813075Thomson 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.
PubMed 38107760Thomson 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.
PubMed 34478115
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01985230
- Acronym / sponsor ID
- ReActiv8-A / 950002
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mainstay MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2024 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReActiv8 Implant | Experimental | Device: ReActiv8 Implantable Stimulation System implanted and activated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReActiv8 Implantable Stimulation System implanted and activated. | Device | ReActiv8 Implant |
Primary outcome
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
1 secondary outcome
Oswestry Disability Index
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 40813075Thomson 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.
- Derived from this study: PubMed 38107760Thomson 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.
- Derived from this study: PubMed 34478115Thomson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReActiv8 Implantable Stimulation System implanted and activated. in people with Chronic Low Back Pain, run by Mainstay Medical at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, Australia, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11 Point Numerical Rating Scale (NRS) for Low Back Pain (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01985230, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.