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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
20/03/2023
Date data sharing statement initially provided
27/05/2019
Date results 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
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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
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Secondary ID [1]
294623
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GRS2017-001
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Universal Trial Number (UTN)
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Trial acronym
SUBWAVE
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Chronic Neuropathic Low Back Pain
307456
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Condition category
Condition code
Anaesthesiology
306541
306541
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0
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Pain management
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Neurological
306575
306575
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
300925
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Treatment: Devices
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Comparator / control treatment
SCS Dose comparison
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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Pain rating (VAS) compared to baseline associated with each paraesthesia-free (sub-perception) stimulation level.
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Assessment method [1]
305549
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Timepoint [1]
305549
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At completion of each stimulation threshold treatment period (6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks).
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Secondary outcome [1]
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(1) Change from baseline of quality of life scores measured by the EQ-5D scale
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Assessment method [1]
345717
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Timepoint [1]
345717
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at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant
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Secondary outcome [2]
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Change from baseline of Brief Pain Inventory scores (BPI)
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Assessment method [2]
345802
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Timepoint [2]
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at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant
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Secondary outcome [3]
345803
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Change from baseline of health status scores (SF-36)
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Assessment method [3]
345803
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Timepoint [3]
345803
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at 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks post implant
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Eligibility
Key inclusion criteria
- Age 18 years or older
- Physician diagnosed neuropathic low back pain
- Candidate for trial of SCS therapy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Non-Randomised
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-Randomised
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Single group
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Other design features
Single-Centre
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2018
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Actual
5/07/2018
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Date of last participant enrolment
Anticipated
1/02/2020
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Actual
1/12/2020
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Date of last data collection
Anticipated
18/02/2022
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Actual
11/04/2022
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Sample size
Target
30
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
22458
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2292 - Broadmeadow
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Funding & Sponsors
Funding source category [1]
299238
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Commercial sector/Industry
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Name [1]
299238
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Medtronic
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Address [1]
299238
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2 Alma Road Macquarie Park NSW 2113
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Country [1]
299238
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Genesis Research Services
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Address
220 Denison St Broadmeadow NSW 2292
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Country
Australia
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Secondary sponsor category [1]
298512
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None
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Name [1]
298512
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NONE
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Address [1]
298512
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NA
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Country [1]
298512
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300162
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Bellberry Limited
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Ethics committee address [1]
300162
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129 Glen Osmond Road Eastwood South Australia 5063
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Ethics committee country [1]
300162
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Australia
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Date submitted for ethics approval [1]
300162
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17/04/2018
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Approval date [1]
300162
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22/05/2018
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Ethics approval number [1]
300162
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2018-04-285
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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.
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Trial website
NA
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Trial related presentations / publications
NA
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Public notes
NA
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Contacts
Principal investigator
Name
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Dr Marc Russo
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Address
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Genesis Research Services Pty Ltd
220 Denison St Broadmeadow NSW 2292
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Country
82742
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Australia
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Phone
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+61 02 49851860
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Fax
82742
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61 02 49622046
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Email
82742
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[email protected]
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Contact person for public queries
Name
82743
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Julia Kuszewski
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Address
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Genesis Research Services Pty Ltd
220 Denison St Broadmeadow NSW 2292
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Country
82743
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Australia
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Phone
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+61 02 49851860
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Fax
82743
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61 02 49622046
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Email
82743
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[email protected]
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Contact person for scientific queries
Name
82744
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Julia Kuszewski
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Address
82744
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Genesis Research Services Pty Ltd
220 Denison St Broadmeadow NSW 2292
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Country
82744
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Australia
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Phone
82744
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+61 02 49851860
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Fax
82744
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+61 02 49622046
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Email
82744
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
no plan to make individual data available in accordance with original data management plans
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
2154
Ethical approval
374921-(Uploaded-23-05-2019-08-57-15)-Study-related document.pdf
2155
Informed consent form
374921-(Uploaded-29-04-2020-12-32-14)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study.
2023
https://dx.doi.org/10.1016/j.neurom.2023.06.007
N.B. These documents automatically identified may not have been verified by the study sponsor.
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