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Trial registered on ANZCTR


Registration number
ACTRN12620000939998
Ethics application status
Approved
Date submitted
17/06/2020
Date registered
21/09/2020
Date last updated
27/10/2021
Date data sharing statement initially provided
21/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized, Controlled, Multi-Center, Non-Inferiority Trial to Evaluate the Safety and Efficacy of Ultra-Low Frequency Spinal Cord Stimulation Compared to Traditional Spinal Cord Stimulation in Subjects with Chronic Back Pain with/without Leg Pain
Scientific title
A Randomized, Controlled, Multi-Center, Non-Inferiority Trial to Evaluate the Safety and Efficacy of Ultra-Low Frequency Spinal Cord Stimulation Compared to Traditional Spinal Cord Stimulation in Subjects with Chronic Back Pain with/without Leg Pain
Secondary ID [1] 301474 0
Nil
Universal Trial Number (UTN)
U1111-1253-2897
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower Back Pain 317797 0
Leg Pain 317798 0
Condition category
Condition code
Neurological 315859 315859 0 0
Other neurological disorders
Musculoskeletal 315860 315860 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to compare the safety and efficacy of Ultra-Low Frequency Spinal Cord Stimulation (ULF-SCS Presidio System) to Traditional Spinal Cord Stimulation (SCS) over a 15 day period in subjects with chronic, intractable back pain with/without leg pain.

The Presidio Medical ULF-SCS system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) and low frequency (1-500Hz) electrical currents to the epidural space to block the conduction of nerve pain.

The participants will have epidural leads implanted for 15 days in an operating room setting. It will be performed by a pain management specialist surgeon in a day surgery setting under general or sedation anaesthesia with a procedure lasting approximately 1 hr. The trial system consists of epidural leads (implanted in the T8-T10 region), lead adapters, an external pulse generator (EPG), surface electrodes and a programming application. The participant will wear the EPG on a hip belt and will have control to continue, pause or stop stimulation.

The participant will return to the clinic at days 1, 3 and 7 to adjust their stimulation. The device is anticipated to provide near continuous stimulation throughout the trial though it is able to be paused or stopped by the participant. The entire system will be removed at Day 15. The usage data from the device will be downloaded at every clinic visit to assess for total run time and device performance.

The study utilizes a multi-centre, prospective, randomized, controlled, non-inferiority two-arm design. Randomization to a control Group allows for the ability to discriminate between improvement in outcomes due to the investigational treatment vs standard therapy. The nature of the two types of stimulation precludes blinding of subjects and study staff. Traditional SCS generates paresthesia whereas ULF-SCS does not.
Intervention code [1] 317786 0
Treatment: Devices
Comparator / control treatment
Traditional Spinal Cord Stimulation (SCS - Standard Therapy). Subjects return at Day 0 and will be randomized to the ULF-SCS group or the Tonic SCS group in a 1:1 ratio. On study visit Day 1 subjects will return for the study device programming according to their randomization group. Stimulation parameters will be adjusted before the subject is sent home with the study device. The ULF-SCS differs from Traditional Spinal Cord Stimulation in the type of energy waveform that it delivers. Both types of spinal cord stimulation require surgical implantation of the leads but as these are trial leads, the IPG battery remains external. The external stimulation will be programmed to the needs required by the participant - it may be left on for the entire day or programmed as per needs. This will be discussed with the clinical field specialist post implantation.
You will need to return to the clinic post implantation on Day 1, Day 3, Day 7, and Day 15 to have the device checked and your program changed if you require greater pain relief or if the settings are too high.
The minimum frequency of stimulation/electrical current if you are assigned to the traditional spinal cord stimulation cohort is 2 Hz - the maximum frequency is 2000 Hz.
Control group
Active

Outcomes
Primary outcome [1] 324069 0
The primary efficacy endpoint will be a review of mean change in VAS score for back pain intensity from baseline to Day 15 Day 15 between ULF-SCS and Traditional SCS.
Timepoint [1] 324069 0
Data will be collected at all participant visits including Day 0 (implant procedure) through to Day 23 (study Exit).
Primary outcome [2] 324070 0
The primary safety endpoint will be the percentage of subjects that experience one or more device, procedure, and/or stimulation related adverse events in the ULF-SCS group compared to the Traditional SCS group. Adverse events will be assessed via clinical examination as well as participant self-reported signs and symptoms. These will be reviewed in detail by the Investigators and recorded as appropriate. A DSMB will review all adverse events. Examples of known/possible adverse events include paresthesia in unwanted areas, pain at the implant site, infection, tingling sensation. These will be discussed with you at the time of your initial visit.
Timepoint [2] 324070 0

Adverse events will be collected at the following visits:
Baseline visit, Day 0, Day 1, Day 3, Day 7, Day 15 and Day 23.
Secondary outcome [1] 383672 0
The secondary efficacy endpoints for this study will include a comparison between ULF-SCS and Traditional SCS for the following measures:
• Mean change in VAS score for pain intensity in leg pain from baseline to Days 3, 7, and 15

Timepoint [1] 383672 0
This outcome will be assessed from Baseline through to Day 3, Day 7 and Day 15.
Secondary outcome [2] 384909 0
Mean change in Oswestry disability Index (ODI 2.1a) score from baseline to Days 3, 7, and Day 15.
Timepoint [2] 384909 0
ODI will be collected at Baseline, Days 3, 7 and 15.
Secondary outcome [3] 384910 0
Percentage of pain relief will be determined by calculating individual participant's change in pain score from baseline by calculating individual participant's change in pain score from baseline at Days 7 and 15. This will be a composite secondary outcome of the percentage of participants with 100%, 50% or greater and 80% or greater pain relief. VAS (Visual Analogue Score Questionnaire) will be used to calculate the pain score.
Timepoint [3] 384910 0
Percentage Pain Relief will be assessed at Days 7 and Days 15.
Secondary outcome [4] 384911 0
Percentage of subjects with a clinically meaningful change (defined as a 15 point or greater decrease) from baseline in ODI score on Days 7 and 15
Timepoint [4] 384911 0
This timepoint will be assessed at Days 7 and Day 15.
Secondary outcome [5] 384912 0
Percentage of subjects in each ODI category at baseline.
Timepoint [5] 384912 0
This timepoint will be assessed at Days 7 and Day 15.

Eligibility
Key inclusion criteria
1. Eighteen (18) years of age or older
2. Literate, able to speak English and able to complete questionnaires independently
3. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
4. Have been diagnosed with chronic low back pain with/without associated leg pain (VAS greater than 50mm for the past week), which has been refractory to conservative therapy for a minimum of 3 months
5. Are currently receiving optimal medical management and considered medically stable as judged by investigator
6. Ability to independently change AA batteries and operate EPG.
7. Able to comply with study requirements and attend all scheduled visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. If female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least two years post-menopausal
2. Severe cognitive impairment as determined by Investigator
3. A psychological assessment will be performed at Baseline to exclude an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome. This will be performed by a clinical psychologist/ psychiatrist
4. Pre-existing motor, balance, proprioception, or sensory deficits as determined by investigator
5. Spinal stenosis or other structural spinal abnormality observed on MRI that would make lead placement unsafe or untowardly difficult as determined by investigator
6. Average total daily morphine equivalent dose (MED) of greater than 100 mg
7. Currently taking anticoagulants including Warfarin, Heparin, Low Molecular Weight Heparin, Factor Xa inhibitors, GPIIb/IIIa inhibitors, thienopyridine inhibitors, direct thrombin inhibitors, or any other anticoagulant that is a contraindication to epidural lead placement within 1 week of the Screening Visit
8. Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by clinical history and, if clinically indicated, by coagulation screening)
9. Cardiac demand pacemaker, implanted defibrillator or another implanted electronic device
10. A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.)
11. Known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject
12. Previous use of spinal cord stimulation or comparable therapy
13. For subjects with diagnosed diabetes, a Hemoglobin A1C (HgB A1C) level that is greater than (greater than) 8.55%
14. Body Mass Index (BMI) score that is greater than 40
15. Diagnosis of Fibromyalgia
16. VAS of greater than 30mm in any area other than back or legs
17. A known need for an MRI or surgery within a 2-week period of the screening visit.
18. Any experimental drug or device used within 30 days prior to the Screening Visit or during the course of the clinical trial
19. No access to a computer or mobile device
20. Subjects who are involved in ongoing or closed litigation related to their pain condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation for randomisation will be via central randomisation via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software - 1;1 ratio via permuted block randomisation with randomisation stratified by the clinical site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary Efficacy Endpoint Analysis
The per-protocol non-inferiority comparison of the mean change in the VAS score for low back pain intensity from baseline to Day 15 will compare the ULF-SCS and Traditional SCS groups using a general linear model which includes randomization and stratum as fixed effects. The model derived mean difference and 95% confidence interval will be used to summarize this comparison. The null hypothesis tested with this non-inferiority study is that the ULF-SCS has a 20% poorer reduction in back pain VAS when compared with the Traditional SCS group. If this null hypothesis is rejected, then non-inferiority can be claimed.

Primary Safety Endpoint Analysis
The primary safety endpoint, the percentage of subjects that experience one or more device, procedure, and/or stimulation related adverse event will be summarized for each randomized group. The individual adverse events will be listed with details including the onset day relative to surgery, severity grade, resolution status, system organ class and description of the event.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/09/2020
Date of last participant enrolment
Anticipated
26/03/2021
Actual
6/05/2021
Date of last data collection
Anticipated
30/04/2021
Actual
3/06/2021
Sample size
Target
70
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment postcode(s) [1] 30502 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 30503 0
5006 - North Adelaide
Recruitment postcode(s) [3] 30504 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 305912 0
Commercial sector/Industry
Name [1] 305912 0
Presidio Medical AU Pty Ltd
Country [1] 305912 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Presidio Medical AU, Pty Ltd
Address
58 Gipps Street, Collingwood VIC 3066
Country
Australia
Secondary sponsor category [1] 306366 0
None
Name [1] 306366 0
Address [1] 306366 0
Country [1] 306366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306163 0
Bellberry HREC
Ethics committee address [1] 306163 0
123 Glen Osmond Street, Eastwood S.A. 5063
Ethics committee country [1] 306163 0
Australia
Date submitted for ethics approval [1] 306163 0
19/06/2020
Approval date [1] 306163 0
25/08/2020
Ethics approval number [1] 306163 0
2020-06-513

Summary
Brief summary
This study seeks to evaluate the safety and the effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of lower back pain with or without leg pain. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength than other traditional spinal cord stimulators and it may help to alleviate pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102930 0
Dr Willem Volschenk
Address 102930 0
Genesis Research Services, 220 Denison Street, Broadmeadow NSW 2292
Country 102930 0
Australia
Phone 102930 0
+61 2 4985 1860
Fax 102930 0
Email 102930 0
[email protected]
Contact person for public queries
Name 102931 0
Willem Volschenk
Address 102931 0
Genesis Research Services, 220 Denison Street, Broadmeadow NSW 2292
Country 102931 0
Australia
Phone 102931 0
+61 2 4985 1860
Fax 102931 0
Email 102931 0
[email protected]
Contact person for scientific queries
Name 102932 0
Andrew Sullivan
Address 102932 0
Presidio Medical AU, Pty Ltd, 58 Gipps Street, Collingwood VIC 3066
Country 102932 0
Australia
Phone 102932 0
+61 448673393
Fax 102932 0
Email 102932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be aggregated.


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.