Chronic Low Back PainReActiv8-CNCT03255200

ReActiv8 Post Market Surveillance Registry

An observational study of Chronic Low Back Pain, run by Mainstay Medical at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Low Back Pain
What is being tested?: ReActiv8 Implantable Stimulation System
Type of treatment: Medical device
How many people: 87 participants
Where: 5 sitesGermany
Study dates: 9 Oct 2017to 8 Dec 2023
How long will I take part?: 2 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population for this registry is persons with chronic low back pain who are indicated for ReActiv8.

Who may be able to join

Meet the Indications for ReActiv8
Willing to sign the Informed Consent for the Registry
Age ≥ 18 years

Who cannot join

1. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

BG Klinikum Bergmannstrost
Halle
Medizinisches Versorgungszentrum Steinburg gGmbH
Itzehoe
Katholisches Klinikum Koblenz
Koblenz
Klinikum Magdeburg
Magdeburg
Orthopadisches Krankenhaus Schloss Werneck
Werneck, Balthasar-Neumann, 97440

Other trials in Germany

About this study

Official title: ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

Conditions: Chronic Low Back Pain
Being tested: ReActiv8 Implantable Stimulation System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReActiv8 Implantable Stimulation SystemDevice
Implantable electrical stimulation system.

What is being measured

The primary outcome is the main question the study is designed to answer.

Low Back Pain - Numeric Pain Rating (NRS) Scale
Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain.
Measured: 90 days, 180 days, 1 year, 2 years post Activation

Secondary outcomes (1)

Serious Adverse Device Effects
All serious device- or procedure-related adverse events.
Measured: Through 2 years post Activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 20178 Dec 2023

First posted21 Aug 2017
Study start9 Oct 2017
Primary completion20 Mar 2023
Study completion8 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 87 participants (actual)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT03255200
Sponsor's protocol ID: 950066
Acronym: ReActiv8-C
Status last verified: Oct 2024
First submitted: 15 Aug 2017
Last updated: 16 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
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Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
ClinicalTrials.gov ID: NCT03255200
Acronym / sponsor ID: ReActiv8-C / 950066
Conditions: Chronic Low Back Pain
Study type: Observational
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Mainstay MedicalIndustry (pharma, biotech, devices)
Study start: 9 Oct 2017 (actual)
Primary completion: 20 Mar 2023 (actual)
Study completion: 8 Dec 2023 (actual)
First posted: 21 Aug 2017 (actual)
Results: Posted 16 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 2 Years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population for this registry is persons with chronic low back pain who are indicated for ReActiv8.

Key inclusion criteria (3 listed)

Meet the Indications for ReActiv8
Willing to sign the Informed Consent for the Registry
Age ≥ 18 years

Key exclusion criteria (1 listed)

1. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.

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 SystemImplantable electrical stimulation system.	Device	–

Primary outcome

Low Back Pain - Numeric Pain Rating (NRS) Scale
Time frame: 90 days, 180 days, 1 year, 2 years post Activation
Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain.

1 secondary outcome

Serious Adverse Device Effects
Time frame: Through 2 years post Activation

Results and safety

Results posted to the registry on 16 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ReActiv8	87	74

Primary outcome: Low Back Pain - Numeric Pain Rating (NRS) Scale

Time frame: 90 days, 180 days, 1 year, 2 years post Activation. Mean (Standard Deviation). Unit: units on a scale

Measure	ReActiv8 n = 87
Month 3	4.5 (2.3)
Month 6	4.3 (2.6)
Year 1	3.8 (2.5)
Year 2	3.4 (2.7)

Population analysed: Of the 87 patients implanted, 84 completed the Day 3 month, 85 completed the Day 6 month, 79 completed the Year 1 visit, and 74 completed the Year 2 visit. Some patients were withdrawn or lost to follow-up.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ReActiv8	21 of 87 (24.1%)	6 of 87 (6.9%)	1 of 87

Limitations and caveats (from the sponsor): This study was an open-label registry with no formal statistical hypotheses. The sample size was based on the desire to gain a sufficient amount of representative data with the device in the post-market setting. It provides real-world data on the safety and performance of the device but is not a robust clinical trial, and thus, has the potential for bias.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Low Back Pain

Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain

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.

Stefan Schu, MD principal investigator

SANA Klinikum Duisburg

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Low Back Pain, run by Mainstay Medical at 5 sites in Germany.

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 3 inclusion and 1 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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?

Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Low Back Pain - Numeric Pain Rating (NRS) Scale (time frame: 90 days, 180 days, 1 year, 2 years post Activation). 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 NCT03255200.

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 16 Oct 2024.