Trial Review

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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 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
Sex
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
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
5/07/2018
Date of last participant enrolment
Anticipated
1/02/2020
Actual
1/12/2020
Date of last data collection
Anticipated
18/02/2022
Actual
11/04/2022
Sample size
Target
30
Accrual to date
Final
27
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
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
Dr Julia Kuszewski
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
r.manager@genesisresearchservices.com
Contact person for scientific queries
Name 82744 0
Dr Julia Kuszewski
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
r.manager@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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2154Ethical approval    374921-(Uploaded-23-05-2019-08-57-15)-Study-related document.pdf
2155Informed consent form    374921-(Uploaded-29-04-2020-12-32-14)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 374921-(Uploaded-15-03-2023-14-24-56)-Basic results summary.docx
Plain language summaryNo This study was testing if a new form of spinal cor... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study.2023https://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.