An observational study in Chronic Low Back Pain, sponsored by Mainstay Medical. Completed at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Mainstay Medical · Observational
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.
The study population for this registry is persons with chronic low back pain who are indicated for ReActiv8.
Exclusion Criteria:
Implantable electrical stimulation system.
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.
Time frame: 90 days, 180 days, 1 year, 2 years post Activation
Serious Adverse Device Effects
All serious device- or procedure-related adverse events.
Time frame: Through 2 years post Activation
| Milestone | ReActiv8 |
|---|---|
| Started | 87 |
| Implanted | 87 |
| Month 3 | 85 |
| Month 6 | 85 |
| Year 1 | 80 |
| Year 2 | 74 |
| Completed | 74 |
| Not completed | 13 |
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.
| units on a scale | ReActiv8 |
|---|---|
| Month 3 | 4.5 ± 2.3 |
| Month 6 | 4.3 ± 2.6 |
| Year 1 | 3.8 ± 2.5 |
| Year 2 | 3.4 ± 2.7 |
All serious device- or procedure-related adverse events.
| Participants | ReActiv8 |
|---|---|
| Serious Adverse Device Effects | 0 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ReActiv8 | 1/87 (1.1%) | 21/87 (24.1%) | 6/87 (6.9%) |
| Event | ReActiv8 |
|---|---|
| Myocardial infarctionCardiac disorders | 2/87 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/87 |
| Allergic UrticariaSkin and subcutaneous tissue disorders | 1/87 |
| Stomach painGastrointestinal disorders | 1/87 |
| Upper back painMusculoskeletal and connective tissue disorders | 1/87 |
| Urinary Tract InfectionInfections and infestations | 1/87 |
| Lung CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/87 |
| Herniated discMusculoskeletal and connective tissue disorders | 1/87 |
| RadiculopathyNervous system disorders | 1/87 |
| Vocal cord paresisNervous system disorders | 1/87 |
| Event | ReActiv8 |
|---|---|
| Pain SacroiliacMusculoskeletal and connective tissue disorders | 6/87 |
| Age, Continuous(years) | ReActiv8 |
|---|---|
| Mean | 52.9 ± 13.0 |
| Sex: Female, Male(Participants) | ReActiv8 |
|---|---|
| Female | 53 |
| Male | 34 |
| Race and Ethnicity Not Collected(Participants) | ReActiv8 |
|---|
| Region of Enrollment(participants) | ReActiv8 |
|---|---|
| Germany | 87 |
| Numeric Pain Rating (NRS) Scale(units on a scale) | ReActiv8 |
|---|---|
| Mean | 7.6 ± 1.2 |
| Oswestry Disability Index (ODI)(units on a scale) | ReActiv8 |
|---|---|
| Mean | 42.4 ± 15.6 |
| European Quality of Life - Five Dimensions (EQ-5D)(units on a scale) | ReActiv8 |
|---|---|
| Mean | 0.5 ± 0.2 |
| Opioid Use(Participants) | ReActiv8 |
|---|---|
| Count of participants | 26 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mainstay Medical