Chronic Low Back Pain
Conditions
Brief 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.
Interventions
DEVICEReActiv8 Implantable Stimulation System
Implantable electrical stimulation system.
Sponsors
Mainstay Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Meet the Indications for ReActiv8 2. Willing to sign the Informed Consent for the Registry 3. Age ≥ 18 years
Exclusion criteria
1\. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Back Pain - Numeric Pain Rating (NRS) Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Effects | Through 2 years post Activation | All serious device- or procedure-related adverse events. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ReActiv8 All participants implanted with ReActiv8 at baseline. | 87 |
| Total | 87 |
Baseline characteristics
| Characteristic | ReActiv8 | — |
|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 13 | — |
| Body Mass Index (BMI) | 28.3 kg/m 2 STANDARD_DEVIATION 5.6 | — |
| European Quality of Life - Five Dimensions (EQ-5D) | 0.5 units on a scale STANDARD_DEVIATION 0.2 | — |
| Numeric Pain Rating (NRS) Scale | 7.6 units on a scale STANDARD_DEVIATION 1.2 | — |
| Opioid Use | 26 Participants | — |
| Oswestry Disability Index (ODI) | 42.4 units on a scale STANDARD_DEVIATION 15.6 | — |
| Pain Duration | 7.7 years STANDARD_DEVIATION 7.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 87 participants | — |
| Sex: Female, Male Female | 53 Participants | — |
| Sex: Female, Male Male | 34 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 87 |
| other Total, other adverse events | 6 / 87 |
| serious Total, serious adverse events | 21 / 87 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReActiv8 | Low Back Pain - Numeric Pain Rating (NRS) Scale | Year 2 | 3.4 units on a scale | Standard Deviation 2.7 |
| ReActiv8 | Low Back Pain - Numeric Pain Rating (NRS) Scale | Month 3 | 4.5 units on a scale | Standard Deviation 2.3 |
| ReActiv8 | Low Back Pain - Numeric Pain Rating (NRS) Scale | Month 6 | 4.3 units on a scale | Standard Deviation 2.6 |
| ReActiv8 | Low Back Pain - Numeric Pain Rating (NRS) Scale | Year 1 | 3.8 units on a scale | Standard Deviation 2.5 |
Secondary
Serious Adverse Device Effects
All serious device- or procedure-related adverse events.
Time frame: Through 2 years post Activation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ReActiv8 | Serious Adverse Device Effects | 0 Participants |