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Trial registered on ANZCTR


Registration number
ACTRN12618000647235
Ethics application status
Approved
Date submitted
17/04/2018
Date registered
23/04/2018
Date last updated
13/05/2021
Date data sharing statement initially provided
27/05/2019
Date results information initially provided
13/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective, Single-Blinded, Dose-Response Study of Spinal Cord Stimulation (SCS) Therapy using Paraesthesia-Free Waveform Patterns in Patients with Chronic Neuropathic Low Back Pain
Scientific title
A Prospective, Single-Blinded, Dose-Response Study of SCS Therapy using Paraesthesia-Free Waveform Patterns in Patients with Chronic Neuropathic Low Back Pain
Secondary ID [1] 294623 0
GRS2017-001
Universal Trial Number (UTN)
Trial acronym
SUBWAVE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic Neuropathic Low Back Pain 307456 0
Condition category
Condition code
Anaesthesiology 306541 306541 0 0
Pain management
Neurological 306575 306575 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will involve the use of the Intellis Implantable Neurostimulator (Medtronic).
The study will involve the use of 1000µs/100Hz stimulation in patients with chronic neuropathic low back pain. The system will be trialled in 2 stages. The first half (3-5 days) of the trial will use commercially established MDT high-density (HD) paraesthesia-free stimulation. The second half (next 3-5 days) of the trial will use a paraesthesia-free (sub-perception) waveform (1000µs/100Hz) at 80% stimulation threshold (80% of the amplitude – voltage – corresponding to 100% stimulation perception). If either stage of the trial is successful, the patient will be implanted.
The patient will then experience the paraesthesia-free (sub-perception) waveform (1000µs/100Hz) at 80% stimulation threshold (80% of the amplitude – voltage – corresponding to 100% stimulation perception) for 6 weeks. Following this 6-week stimulation establishment experience, descending levels of stimulation threshold will be applied by the programmer each month by stepping down the amplitude (voltage) to achieve 60% sub-perception, then 40% for the last 4 week treatment period. Patient-reported outcomes (pain scores, QOL, satisfaction level, etc.) at each of these levels will be clinically assessed to identify patient response to each sub-perception level of stimulation.
The study will be conducted a private research facility by a team of 3 Pain Specialists including the Principal Investigator who has over 20 years experience and has conducted 60+ clinical studies.
Intervention code [1] 300925 0
Treatment: Devices
Comparator / control treatment
SCS Dose comparison
Control group
Dose comparison

Outcomes
Primary outcome [1] 305549 0
Pain rating (VAS) compared to baseline associated with each paraesthesia-free (sub-perception) stimulation level.
Timepoint [1] 305549 0
At completion of each stimulation threshold treatment period (6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks).
Secondary outcome [1] 345717 0
(1) Change from baseline of quality of life scores measured by the EQ-5D scale

Timepoint [1] 345717 0
at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant
Secondary outcome [2] 345802 0
Change from baseline of Brief Pain Inventory scores (BPI)
Timepoint [2] 345802 0
at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant
Secondary outcome [3] 345803 0
Change from baseline of health status scores (SF-36)
Timepoint [3] 345803 0
at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant

Eligibility
Key inclusion criteria
- Age 18 years or older
- Physician diagnosed neuropathic low back pain
- Candidate for trial of SCS therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Meets any contraindication for SCS therapy
- Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator

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)
Non-Randomised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-Randomised
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Single-Centre
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For numerical outcomes, mean score at baseline and at each treatment stage / endpoint will be calculated. Mean percentage change in outcomes will be calculated as the percentage difference in score per patient (at each treatment stage / endpoint) compared to baseline. Statistical significance will be conducted if appropriate using paired t-tests and assessed against a significance level of p=0.05. Within-patient differences will be assessed using 95% confidence intervals. Multivariate analysis may be performed if appropriate

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22458 0
2292 - Broadmeadow

Funding & Sponsors
Funding source category [1] 299238 0
Commercial sector/Industry
Name [1] 299238 0
Medtronic
Address [1] 299238 0
2 Alma Road Macquarie Park NSW 2113
Country [1] 299238 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Genesis Research Services
Address
220 Denison St Broadmeadow NSW 2292
Country
Australia
Secondary sponsor category [1] 298512 0
None
Name [1] 298512 0
NONE
Address [1] 298512 0
NA
Country [1] 298512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300162 0
Bellberry Limited
Ethics committee address [1] 300162 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 300162 0
Australia
Date submitted for ethics approval [1] 300162 0
17/04/2018
Approval date [1] 300162 0
22/05/2018
Ethics approval number [1] 300162 0
2018-04-285

Summary
Brief summary
The purpose of this study is to evaluate the effectiveness of paraesthesia-free (sub-perception) waveform patterns for patients with chronic neuropathic low back pain.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 82742 0
Dr Marc Russo
Address 82742 0
Genesis Research Services Pty Ltd
220 Denison St Broadmeadow NSW 2292
Country 82742 0
Australia
Phone 82742 0
+61 02 49851860
Fax 82742 0
61 02 49622046
Email 82742 0
pi@genesisresearchservices.com
Contact person for public queries
Name 82743 0
Mr Eleanor Ramsay
Address 82743 0
Genesis Research Services Pty Ltd
220 Denison St Broadmeadow NSW 2292
Country 82743 0
Australia
Phone 82743 0
+61 02 49851860
Fax 82743 0
61 02 49622046
Email 82743 0
elle@genesisresearchservices.com
Contact person for scientific queries
Name 82744 0
Mr Eleanor Ramsay
Address 82744 0
Genesis Research Services Pty Ltd
220 Denison St Broadmeadow NSW 2292
Country 82744 0
Australia
Phone 82744 0
+61 02 49851860
Fax 82744 0
+61 02 49622046
Email 82744 0
elle@genesisresearchservices.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no plan to make individual data available in accordance with original data management plans
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2154 0
Ethical approval
Citation [1] 2154 0
Link [1] 2154 0
Email [1] 2154 0
Other [1] 2154 0
Type [2] 2155 0
Informed consent form
Citation [2] 2155 0
Link [2] 2155 0
Email [2] 2155 0
Other [2] 2155 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary