ReActiv8 Observational Registry for Chronic Low Back Pain

ReActiv8 Observational Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12621001469808

Enrollment

Registered

2021-10-27

Start date

2021-12-08

Completion date

2023-11-28

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The ReActiv8 Observational Registry is a multi-center, data collection registry in patients who are being considered for a ReActiv8 implant. At the time of implant, patients must meet the indications and not be contraindicated for ReActiv8. If it is determined that a patient will not be implanted, the patient will be exited from the Registry. Implanted patients will be followed for two years post-activation, at which point they will be exited from the Registry. The ReActiv8 device is approved by the TGA for use in Australia for the indications above and its implantation in participating centres is standard of care.

Interventions

Observational prospective collection of patient reported outcome measures in a cohort indicated for treatment with restorative neurostimulation. Participants will provide weekly pain measurements, 3 monthly reports of disability and health related quality of life. Patients will be followed for 2 years. Patients will be offered ReActiv8 regardless of their participation in the study.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion Criteria In order to be included in this Registry, Subjects must meet the following inclusion criteria: 1. Meet the Indications for ReActiv8 for the treatment of chronic low back pain 2. Willing to sign the Informed Consent for the Observational Registry 3. Owns a compatible smartphone (Android or iPhone) and willing to utilize the smartphone app

Exclusion criteria

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

Outcome results