Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000903785
Ethics application status
Approved
Date submitted
6/04/2022
Date registered
24/06/2022
Date last updated
20/09/2023
Date data sharing statement initially provided
24/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ReActiv8 Therapy after Lower Lumbar Uninstrumented Spinal Surgery
Scientific title
Examining the Effect of ReActiv8® Therapy in a Cohort of Patients with Refractory Mechanical Low Back Pain after Lower Lumbar Uninstrumented Spinal Surgery
Secondary ID [1] 306619 0
None
Universal Trial Number (UTN)
Not applicable
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 325536 0
Condition category
Condition code
Musculoskeletal 322907 322907 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
The ReActiv8 System is indicated as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing. This study will be a single arm prospective study using two cohorts. Cohort 1 will be 30 patients who have mechanical low back pain (LBP) for > or equal to 12 months following a discectomy procedure in the L3/L4, L4/L5, or L5/S1 spinal levels. Cohort 2 will be 30 patients who have had chronic LBP > or equal to 12 months following a lumbar laminectomy in the L4 and/or L5 spinal levels. The study will consist of up to 60 patients implanted with ReActiv8, who are indicated for and agree to participation in this study. There is no pre-specified window from enrolment to ReActiv8 implant as the implant proceeds under normal standard of care and does not form part of this study. Participants who decline to be in the study will still have access to the ReActiv8 implant and will be followed up separately outside of the study as part of the International Spine Centre’s clinical care pathway.

At the Baseline Visit, participants will come to the clinic to complete functional testing (touch toes, extend back, reach down leg to left and then to the right) with a physiotherapist and a series of Patient Reported Outcome Measures (PROMs) under the supervision of the principal investigator.

The device implant will be completed as described by the implanting surgeon. The procedure to implant the device proceeds under normal standard of care and does not form part of this study.

Participants will return for the Activation and Re-programming visits at approximately the 2-week timepoint and 45-day timepoint, in alignment with the standard of care follow-up visit schedule. The implanted ReActiv8 IPG is wirelessly programmed by the physician to meet their specific needs for 2 sessions per day for 30 minutes each. The implant analytics can be utilised to monitor adherence to the therapy.

Participants will also return to the clinic at the follow-up visits specified per protocol (6, 12, and 24 months post-activation) to complete functional testing and a series of PROMs. Additional items such as adverse events and changes to LBP medication use will be collected. Each follow-up visit is anticipated to take one hour. Participants will be followed for 24 months post-activation.
Intervention code [1] 323058 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator or control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330680 0
Change in levels of LBP (using a Numerical Rating Scale – NRS)
Timepoint [1] 330680 0
12 months post-activation
Primary outcome [2] 331032 0
Change in levels of disability (using the Oswestry Disability Index – ODI)
Timepoint [2] 331032 0
12 months post-activation
Secondary outcome [1] 407198 0
Change in levels of pain (using a Numerical Rating Scale – NRS)
Timepoint [1] 407198 0
6 Months and 24 Months post-activation
Secondary outcome [2] 407199 0
Treatment Satisfaction Score at follow-up visits using Treatment Satisfaction Questionnaire (TSQ)
Timepoint [2] 407199 0
6, 12, and 24 months post-activation
Secondary outcome [3] 407200 0
Patient assessment of their care at follow-up visits using Subject Global Impression of Care questionnaire (SGIC)
Timepoint [3] 407200 0
6, 12, and 24 months post-activation
Secondary outcome [4] 408291 0
Change in LBP medication requirements from Baseline Visit to follow-up visits (via participant self-report and/or review of pharmacy records)
Timepoint [4] 408291 0
6, 12, and 24 months post-activation
Secondary outcome [5] 408292 0
Incidence of device deficiencies at follow-up visits (via Investigator and study staff observation report)
Timepoint [5] 408292 0
6, 12, and 24 months post-activation
Secondary outcome [6] 408293 0
Incidence and type of surgical and device related adverse events at follow-up visits (composite).

The potential risks of implantation and use of the ReActiv8 system are outlined in the patient user manual. Surgical and device related adverse events include events associated with the surgical procedure, including implant, revision, replacement, and removal. Adverse events will be recorded and assessed by the Clinician at the study visits outlined per protocol.
Timepoint [6] 408293 0
6, 12, and 24 months post-activation
Secondary outcome [7] 408294 0
Change in Quality of Lifestyle from Baseline Visits to follow-up visits using the Euro-Qol Five Dimensions (EQ-5D) Questionnaire
Timepoint [7] 408294 0
6, 12 and 24 months post-activation
Secondary outcome [8] 408295 0
Change in work status from Baseline Visit to follow-up visits

Work status will be collected via series of questions collected by the Researcher, including patient's current work status, current type of work, current ability to do his/her usual work compared to highest ability to work ever, and number of workdays missed due to LBP in the last 12 months.
Timepoint [8] 408295 0
6, 12, and 24 months post-activation
Secondary outcome [9] 408296 0
Assessment of Health Care Utilisation for back pain LBP (office visits, hospital visits, imaging and diagnostics and other pain management treatments) at follow-up visits (via patient self-report)
Timepoint [9] 408296 0
6, 12, and 24 months post-activation
Secondary outcome [10] 408297 0
Changes in lumbo-pelvic kinematics from Baseline Visit to follow up visits (using the Vimove™ system, a system designed to measure and quantify lumbar movement)
Timepoint [10] 408297 0
6, 12, and 24 months post-activation
Secondary outcome [11] 408547 0
Change in levels of disability (using the Oswestry Disability Index – ODI)
Timepoint [11] 408547 0
6 Months and 24 Months post-activation

Eligibility
Key inclusion criteria
1. Ages 18-75 years old
2. Meets the current clinical indications for ReActiv8 implantation
3. Mechanical (non-neuropathic) LBP Numerical Rating Scale (NRS) > or equal to 6 (out of 10)
4. Oswestry Disability Index (ODI) score > or equal to 21 points but < or equal to 60 points
5. Decompression lower lumbar spinal surgery (discectomy or laminectomy) in the L3/L4, L4/L5, or L5/S1 spinal levels greater than or equal to 12 months prior to the Baseline Visit
6. Magnetic Resonance Imaging (MRI) showing pathology as the likely cause of CLBP with no simple surgically remedial cause for the pain
7. No psychological contraindications as determined by the Investigator
8. Exhibit lumbar instability due to a motor control deficit in the lumbar multifidus (Positive Prone Instability Test – PIT, or Multifidus Lift test – MLT)
9. Has not shown improvement following comprehensive medical management and a physical therapy program
10. Able to provide informed consent
11. Ability to comply with the instructions for use (IFU) to operate ReActiv8, and to comply with this Clinical Study Plan
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Leg pain described as being worse than back pain, or radiculopathy below the knee (with or without neurological deficit (e.g. footdrop)
2. Neuropathic dominant pain (PainDETECT >19)
3. Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post-herpetic neuralgia)
4. Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia)
5. Spondylolisthesis greater than Grade II
6. Spondylosis with instability
7. Infection (local or generalized)
8. Scoliosis (Cobb angle > 30°) in lumbar spine
9. Back pain due to vascular causes such as aortic aneurysm and dissection
10. Source of pain is the sacroiliac joint as determined by the Investigator
Surgical or other procedure exclusions:
11. Any previous rhizotomy or rhizolysis procedure, including cryoablation, radiofrequency ablation or pulsed radiofrequency on the dorsal root ganglion (DRG) or the medial branch of the dorsal ramus nerve that crosses or lies below the T8 vertebra, within three months prior to the Baseline Visit.
12. Anesthetic block of the DRG or medial branch of dorsal ramus nerve that crosses or lies below the T8 vertebra or injection of epidural steroids for back pain in the 30 days prior to the Baseline Visit.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study will consist of up to 60 implanted patients, who are indicated for participation in this study. The two cohorts (discectomy and laminectomy) will be studied longitudinally examining pain, disability, and health quality at various follow up timepoints as outlined. The sample size calculations are based on the outcomes of previous clinical work in LBP patients that have not previously undergone decompression surgery.
Power calculations for this study rely on the following assumptions, based on a prior trial of the ReActiv8 system: minimum power of 80%, Type I error rate of 5%, assumed mean change in group of 20.1, and pooled standard deviation of 15. These suggest a moderate sample size of 10 patients however there are several variables in the current cohort that cannot be accounted for from these data specifically related to the impact of the prior surgery. As such we propose a maximum sample of 60 patients with two cohorts of 30 patients.
When 50% of the patients in each cohort reach the 12-month post activation time point an interim analysis will be conducted. The proportion of patients with a 50% or greater reduction in pain and/or a 20-point reduction in ODI will be assessed. If this is greater than 10 patients, recruitment will be halted for efficacy if this suggests superiority as the treatment under study is clearly established. The remaining patients that have been implanted and yet to reach 12 months will continued to be followed through to their respective 12-month endpoints. The trial will not be stopped for futility at the interim analysis though a post-hoc sample size calculation based on the available data to estimate the likelihood of a statistically significant outcome will be performed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/08/2022
Actual
29/09/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
15/07/2026
Actual
Sample size
Target
60
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 310952 0
Commercial sector/Industry
Name [1] 310952 0
Mainstay Medical (Australia) Pty Ltd
Country [1] 310952 0
Australia
Primary sponsor type
Other
Name
The International Spine Centre
Address
41 Sydenham Rd
Norwood SA 5067
Australia
Country
Australia
Secondary sponsor category [1] 312256 0
None
Name [1] 312256 0
None
Address [1] 312256 0
None
Country [1] 312256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310511 0
Bellberry Limited
Ethics committee address [1] 310511 0
123 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 310511 0
Australia
Date submitted for ethics approval [1] 310511 0
06/04/2022
Approval date [1] 310511 0
01/07/2022
Ethics approval number [1] 310511 0

Summary
Brief summary
It is hypothesised that implantation of the ReActiv8 System will lead to a reduction in pain and/or disability for participants with CLBP, prior decompressive surgery (discectomy or laminectomy), with unsatisfactory pain relief despite continuing medical management (including physical therapy and medications).

This Investigator-Initiated Study will be a single arm prospective study using two cohorts. Cohort 1 will be 30 patients who have mechanical LBP for > or equal to 12 months following a discectomy procedure, and Cohort 2 will be 30 patients who have had chronic LBP > or equal to 12 months following a lumbar laminectomy. The study will consist of up to 60 patients implanted with ReActiv8, who are indicated for participation in this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117910 0
Prof Ian Whittle
Address 117910 0
The International Spine Centre
41 Sydenham Rd
Norwood SA 5067
Country 117910 0
Australia
Phone 117910 0
+61 418 502 287
Fax 117910 0
Email 117910 0
[email protected]
Contact person for public queries
Name 117911 0
Prof Ian Whittle
Address 117911 0
The International Spine Centre
41 Sydenham Rd
Norwood SA 5067
Country 117911 0
Australia
Phone 117911 0
+61 418 502 287
Fax 117911 0
Email 117911 0
[email protected]
Contact person for scientific queries
Name 117912 0
Prof Ian Whittle
Address 117912 0
The International Spine Centre
41 Sydenham Rd
Norwood SA 5067
Country 117912 0
Australia
Phone 117912 0
+61 418 502 287
Fax 117912 0
Email 117912 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?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
At closure of the study, i.e., 2 years after the enrolment of the final patient, data will be available for 5 years.
Available to whom?
As per grant agreement with Mainstay Medical
Available for what types of analyses?
As per grant agreement with Mainstay Medical
How or where can data be obtained?
Access subject to approvals by Principal Investigator

Tel: +61 418 502 287
Email: [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.