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Trial registered on ANZCTR


Registration number
ACTRN12619001252101
Ethics application status
Approved
Date submitted
19/08/2019
Date registered
11/09/2019
Date last updated
6/03/2020
Date data sharing statement initially provided
11/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Single-Arm, Multicenter Study to Evaluate Safety and Efficacy of Low Frequency Spinal Cord Stimulator in Subjects with Low Back and/or Leg Pain
Scientific title
Single-Arm, Multicenter Study to Evaluate Safety and Efficacy of Low Frequency Spinal Cord Stimulator in Subjects with Low Back and/or Leg Pain
Secondary ID [1] 299039 0
Nil
Universal Trial Number (UTN)
U1111-1238-7871
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower back pain 314054 0
Leg Pain 314055 0
Condition category
Condition code
Neurological 312443 312443 0 0
Other neurological disorders
Musculoskeletal 312561 312561 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Presidio system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) impulses to block the conduction of nerve pain. The participants will have epidural leads implanted for up to 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 T6-L2 region), lead adapters, an external pulse generator (EPG)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 1,3,7, and 11 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 every clinic visit to assess for total run time and device performance.
Intervention code [1] 315313 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321093 0
Safety outcome - adverse events and complications will be collected throughout the course of the study. All reported adverse events will be categorized for severity and relationship. The safety outcomes will be a mixture of participant reported data and clinically assessed signs and symptoms. Examples of possible anticipated adverse events include, infection, worsening of pain, neurologic compromise and retained foreign body.
Timepoint [1] 321093 0
Data will be collected at all participant visits including Day 0 (procedure) through to Day 23 (study exit).
Adverse events will be reported ad-hoc and will be assessed at study days 0,1,3,7,11,15 and 23 of the trial.
Primary outcome [2] 321094 0
Effectiveness - to determine the early feasibility of the low frequency SCS. As such, this endpoint will be an exploratory endpoint assessing the visual analog scale (VAS).
Timepoint [2] 321094 0
From Screening through to Day 23 (study exit). Study visits are planned at Days 0, 1, 3, 7, 11, 15 and 23
Secondary outcome [1] 373972 0
A secondary outcome will include assessment of functional capacity by the Oswestry Disability Index.
Timepoint [1] 373972 0
the Oswestry Disability index will be completed at days 0,7 and 15.

Eligibility
Key inclusion criteria
- literate, able to speak English and able to complete questionnaires independently.
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
- have been diagnosed with chronic, intractable pain of the low back and/or legs (VAS greater than or equal to 60mm for the past week) which has been refractory to conservative therapy for a minimum of 3 months.
- Are currently receiving optimal medical management and considered medically stable as judged by the investigator.
- Able to change AA batteries and operate the EPG.
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. IV Contrast allergy
3. Severe cognitive impairment as determined by investigator
4. 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 the investigator in consultation with a clinical psychologist if
applicable
5. Pre-existing motor, balance, proprioception, or sensory deficits as determined
by investigator
6. Spinal Stenosis or other structural spinal abnormality observed on MRI that
would make lead placement unsafe or untowardly difficult as determined by
investigator
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 other 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 non-responder to spinal cord stimulation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Approximately 25 subjects will be enrolled in the study (sample size). Data will be
tested for normality. Data will be analyzed using descriptive statistics and/or typical
statistical analysis for normally distributed data sets (e.g. ANOVA, Tukey’s multiple
comparison test, student’s t-test, etc.) if normally distributed. Appropriate
transformations or tests will be utilized for non-normally distributed data. Additional
statistical tests (e.g. binomial probability tests, etc.) may be used as needed. Analyses
will be performed with all available data and may be repeated with missing data
replaced with the last data point and carried forward.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/08/2019
Date of last participant enrolment
Anticipated
6/05/2020
Actual
21/11/2019
Date of last data collection
Anticipated
29/05/2020
Actual
29/01/2020
Sample size
Target
25
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 27586 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 27587 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 303578 0
Commercial sector/Industry
Name [1] 303578 0
Presidio Medical AU, Pty Ltd
Country [1] 303578 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] 303660 0
None
Name [1] 303660 0
Address [1] 303660 0
Country [1] 303660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304107 0
Bellberry HREC
Ethics committee address [1] 304107 0
Ethics committee country [1] 304107 0
Australia
Date submitted for ethics approval [1] 304107 0
21/05/2019
Approval date [1] 304107 0
09/08/2019
Ethics approval number [1] 304107 0
2019-03-278

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

Contacts
Principal investigator
Name 38602 0
Dr Marc Russo
Address 38602 0
Genesis Research Services
220 Denison Street, Broadmeadow NSW 2292
Country 38602 0
Australia
Phone 38602 0
+61 2 4985 1860
Fax 38602 0
Email 38602 0
info@genesisresearchservices.com
Contact person for public queries
Name 38603 0
Marc Russo
Address 38603 0
Genesis Research Services
220 Denison Street, Broadmeadow NSW 2292
Country 38603 0
Australia
Phone 38603 0
+61 2 4985 1860
Fax 38603 0
Email 38603 0
katie@genesisresearchservices.com
Contact person for scientific queries
Name 38604 0
Andrew Sullivan
Address 38604 0
Presidio Medical AU, Pty Ltd, 58 Gipps Street, Collingwood VIC 3066
Country 38604 0
Australia
Phone 38604 0
+61 4 4867 3393
Fax 38604 0
Email 38604 0
asullivan@presidiomedical.com

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.