Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001469808
Ethics application status
Approved
Date submitted
20/07/2021
Date registered
27/10/2021
Date last updated
16/06/2024
Date data sharing statement initially provided
27/10/2021
Date results information initially provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ReActiv8 Observational Registry for Chronic Low Back Pain
Scientific title
ReActiv8 Observational Registry for the
ReActiv8 Implantable Neurostimulation System
for Chronic Low Back Pain
Secondary ID [1] 304824 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 322902 0
Condition category
Condition code
Musculoskeletal 320494 320494 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 321214 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328324 0
Proportion of patients with a reduction in Disability (Oswestry Disability Index) reduction >15 points over baseline
Timepoint [1] 328324 0
The ODI will be collected at the following time points with the 1 year assessment against baseline being the primary outcome
6 months
1 Year*
2 Years

*timepoint for primary outcome
Secondary outcome [1] 398605 0
Proportion of patients with a reduction in Pain reduction >30% over baseline, using NRS for low back pain
Timepoint [1] 398605 0
6 months
1 year
2 years
Secondary outcome [2] 402030 0
Change in health related quality of life measured by EQ-5D statistically significant change over baseline
Timepoint [2] 402030 0
6 months
1 year
2 years
Secondary outcome [3] 402031 0
Change in PROMIS-29 T-scores against baseline statistically significant change over baseline
Timepoint [3] 402031 0
6 months
1 year
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Where appropriate statistical comparisons to baseline will be made using Repeated Measure ANOVA with post-hoc pairwise comparisons using Bonferroni’s adjustment for multiplicity.
An interim analysis will be completed when at least 50 patients reach both 12 and 24 month follow-up. Further analyses will be completed at other patient completion milestones.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
8/12/2021
Date of last participant enrolment
Anticipated
29/12/2023
Actual
28/11/2023
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
200
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 309197 0
Commercial sector/Industry
Name [1] 309197 0
Mainstay Medical pty ltd
Country [1] 309197 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mainstay Medical pty ltd
Address
Mainstay Medical (Australia) Pty Ltd
13/76 Reserve Road
Artarmon
NSW 2064
Australia
Country
Australia
Secondary sponsor category [1] 310169 0
None
Name [1] 310169 0
Address [1] 310169 0
Country [1] 310169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309051 0
Bellberry
Ethics committee address [1] 309051 0

123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 309051 0
Australia
Date submitted for ethics approval [1] 309051 0
15/06/2021
Approval date [1] 309051 0
20/09/2021
Ethics approval number [1] 309051 0
2021-06-639

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112794 0
Dr Dan Bates
Address 112794 0
Metro Pain Group
271 Clayton Road, Clayton VIC 3168
Country 112794 0
Australia
Phone 112794 0
+61 419304132
Fax 112794 0
Email 112794 0
dbates@[email protected]
Contact person for public queries
Name 112795 0
Dr Dan Bates
Address 112795 0
Metro Pain Group
271 Clayton Road, Clayton VIC 3168
Country 112795 0
Australia
Phone 112795 0
+61 419304132
Fax 112795 0
Email 112795 0
[email protected]
Contact person for scientific queries
Name 112796 0
Dr Dan Bates
Address 112796 0
Metro Pain Group
271 Clayton Road, Clayton VIC 3168
Country 112796 0
Australia
Phone 112796 0
+61 419304132
Fax 112796 0
Email 112796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified PROMs
When will data be available (start and end dates)?
at closure of the study, ie 2 years after the enrolment of the final patient, data will be available for 5 years.
Available to whom?
On reasonable request to the PI
Available for what types of analyses?
Analysis agreed to by PI upon request
How or where can data be obtained?
On reasonable request to the PI: A/Prof Bruce Mitchell [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.