Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000555752
Ethics application status
Approved
Date submitted
10/02/2022
Date registered
11/04/2022
Date last updated
30/05/2024
Date data sharing statement initially provided
11/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient-reported and functional outcomes following ReActiv8 implantable neurostimulation
Scientific title
Patient-reported and functional outcomes following implantable neurostimulation in adults with chronic low back pain
Secondary ID [1] 306265 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 325015 0
Condition category
Condition code
Musculoskeletal 322454 322454 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a single-arm study looking at longitudinal changes in function and patient-reported outcomes (PROMs) following treatment for chronic mechanical low back pain using ReActiv8 restorative neurostimulation. It is important to note that the ReActiv8 device is available commercially, and patients may choose to undergo device implantation outside of this study. However, if patients choose to participate in the study, they will be assessed pre-procedure (baseline), 8-weeks, 27-weeks, and 54-weeks post-implantation.

The procedure: A neurosurgeon is responsible for the implantation of the device. The ReActiv8 leads are introduced under fluoroscopic visualization using a needle, guide wire, and delivery sheath with dilator. Leads are placed bilaterally, with the electrodes placed adjacent to the medial branch of the dorsal ramus as it crosses the transverse process at L3. Leads are tunnelled subcutaneously between the lead implant incision and the IPG pocket. The IPG is placed in a subcutaneous pocket in a location deemed appropriate by the implanting physician, considering the patient’s ability to reach the IPG location for initiation of stimulation with the Activator.
The device: The IPG delivers electrical stimulation pulses to the nerves that activate the lumbar multifudus muscle. Using the wireless remote, the individual is able to start, pause, or stop a session of electrical stimulation. Participants are required to activate the device for 30 minutes, twice a day while lying down. There is no endpoint for the stimultation sessions.

The functional assessments: A Sports Scientist is responsible for the pre and post-implantation performance measures. These assessments will occur at BackSpace Clinic, Brisbane Private Hospital and will take 30 minutes to complete. These include a 30-second Sit-to-Stand, Timed-Up-and-Go walking test, centre of pressure measurements using a force plate and flexion, extension and rotation angles using wearable motion sensors.

The ultrasound: A sonographer performs the radiographic assessment on participants at Brisbane Private Imaging, Brisbane Private Hospital. B-mode ultrasound will capture transverse images of the multifidus muscle at each level from L1-S1 on both sides. Passive muscle stiffness of the multifidus will be assessed with shear wave elastrography at each level between L1-S1 on each side. As a reference figure, transverse images of the achilles tendon will be captured. It is anticipated that the imaging series will take 20 minutes.

The PROMs: The researcher will email seven x PROMs to the patient in advance of their appointment via an online link. The seven questionnaires includes the: Visual Analogue Scale, Oswestry Disability Index, PROMIS-29, Fear of Movement Questionnaire, Pain Self-Efficacy Questionnaire, Quality of Life and the Graded Chronic Pain Scale. Completeting all of the questionnaires will take approximately 20 minutes.
Intervention code [1] 323098 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330237 0
Change in disability as assessed by the Oswestry Disability Index (ODI)
Timepoint [1] 330237 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation (primary timepoint) and 12-months post-activation
Primary outcome [2] 330240 0
Change in pain as assessed by the Visual Analogue Scale (VAS)
Timepoint [2] 330240 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation (primary timepoint) and 12-months post-activation
Secondary outcome [1] 405394 0
Change in chronic pain as assessed by the Graded Chronic Pain Scale (GCPS)
Timepoint [1] 405394 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [2] 405701 0
Change in sleep as assessed by the Insomnia Severity Index (ISI)
Timepoint [2] 405701 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [3] 405702 0
Change in fear of movement as assessed by the Tampa Scale of Kinesiophobia (TSK)
Timepoint [3] 405702 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [4] 405703 0
Change in quality of life as assessed by the EQ-5D-5L
Timepoint [4] 405703 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [5] 405704 0
Change in pain self-efficacy (PSE) questionnaire
Timepoint [5] 405704 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [6] 405705 0
Change in generic health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Timepoint [6] 405705 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [7] 405709 0
Change in trunk flexion as assessed using the DorsaVi wearable sensor
Timepoint [7] 405709 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [8] 405710 0
Change in standing balance as assessed by the VALD ForceDecks
Timepoint [8] 405710 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [9] 405711 0
Change in lower limb strength as assessed by the 30-second Sit-to-Stand (30-STS)
Timepoint [9] 405711 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [10] 405712 0
Change in mobility as assessed by the Timed-Up-and-Go (TUG)
Timepoint [10] 405712 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [11] 405713 0
Change in sleep duration using the FitBit Charge 4
Timepoint [11] 405713 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [12] 405714 0
Change in physical activity as assessed by the FitBit Charge 4
Timepoint [12] 405714 0
Pre-implantation, 6-weeks post-activation, 6-months post-activation and 12-months post-activation
Secondary outcome [13] 405715 0
Change in elasticity of the lumbar multifidus using shear-wave elastography (SWE)
Timepoint [13] 405715 0
Pre-implantation and 6-months post-activation
Secondary outcome [14] 405716 0
Change in multifidus muscle morphology using B-mode ultrasound
Timepoint [14] 405716 0
Pre-implantation and 6-months post-activation
Secondary outcome [15] 406206 0
Change in trunk extension as assessed using the DorsaVi wearable sensor
Timepoint [15] 406206 0
Pre-implantation and 6-months post-activation
Secondary outcome [16] 406207 0
Change in lateral flexion of the trunk using the DorsaVi wearable sensor
Timepoint [16] 406207 0
Pre-implantation and 6-months post-activation
Secondary outcome [17] 406208 0
Change in trunk rotation using the DorsaVi wearable sensor
Timepoint [17] 406208 0
Pre-implantation and 6-months post-activation

Eligibility
Key inclusion criteria
- >18 years of age
- Scheduled for ReActiv8 implantation as determined by two spine surgeons
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active compensation or litigation claims
- Pain in the ankles, feet, hips or knees that prevents sitting down in a chair, rising from a chair or balancing on one leg

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
14/12/2021
Date of last participant enrolment
Anticipated
Actual
7/05/2024
Date of last data collection
Anticipated
7/05/2025
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21561 0
Brisbane Private Hospital - Brisbane
Recruitment postcode(s) [1] 36470 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 310617 0
Commercial sector/Industry
Name [1] 310617 0
Mainstay Medical Pty. Ltd.
Country [1] 310617 0
Ireland
Primary sponsor type
Commercial sector/Industry
Name
BackSpace Clinics Pty Ltd.
Address
259 Wickham Tce, Spring Hill, QLD, 4000
Country
Australia
Secondary sponsor category [1] 311890 0
None
Name [1] 311890 0
Address [1] 311890 0
Country [1] 311890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310221 0
Brisbane Private Hospital Low Risk Ethics Committee
Ethics committee address [1] 310221 0
Ethics committee country [1] 310221 0
Australia
Date submitted for ethics approval [1] 310221 0
05/08/2021
Approval date [1] 310221 0
14/09/2021
Ethics approval number [1] 310221 0
LREC21BPH5

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116898 0
A/Prof Paul Licina
Address 116898 0
SpinePlus, Level 7, 259 Wickham Terrace, Brisbane City QLD 4000
Country 116898 0
Australia
Phone 116898 0
+61 478 194 041
Fax 116898 0
Email 116898 0
[email protected]
Contact person for public queries
Name 116899 0
Patrick Beaumont
Address 116899 0
BackSpace, Level 7, 259 Wickham Terrace, Brisbane City QLD 4000
Country 116899 0
Australia
Phone 116899 0
+61 413427048
Fax 116899 0
Email 116899 0
[email protected]
Contact person for scientific queries
Name 116900 0
Paul Licina
Address 116900 0
SpinePlus, Level 7, 259 Wickham Terrace, Brisbane City QLD 4000
Country 116900 0
Australia
Phone 116900 0
+61 413427048
Fax 116900 0
Email 116900 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be available after dissemination upon request and at the discretion of the sponsor. The data will only be distributed to researchers.

Conditions for requesting access:
• -

What individual participant data might be shared?
• After de-identification, all of the individual participant data will be shared.

What types of analyses could be done with individual participant data?
• Data will be available for primary and secondary analyses on the basis that the secondary analysis is related to the topic of interest.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available immediately following publication and for 15 years following publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access is subject to approvals by the Principal Investigator.
Email: [email protected]
Contact number: +61 413 427 048

Are there extra considerations when requesting access to individual participant data?
No


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.