Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000971437
Ethics application status
Approved
Date submitted
7/07/2016
Date registered
25/07/2016
Date last updated
15/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
High Frequency Peripheral nerve stimulation for chronic pain
Scientific title
High frequency (HF10) peripheral nerve stimulation (PNS) for chronic neuropathic pain
Secondary ID [1] 289609 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
HF10 PNS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Neuropathic Pain 299393 0
Condition category
Condition code
Anaesthesiology 299399 299399 0 0
Pain management
Neurological 299471 299471 0 0
Other neurological disorders
Musculoskeletal 299472 299472 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
This study is a clinical audit of patients undergoing implantation of commercially-available and TGA-approved high frequency stimulators (Nevro high frequency stimulator and electrode leads, TGA certificate DV-2011-MC-00182-3) in the clinical management of pain. Pain ratings, Oswestry Disability ratings, patient satisfaction and morphine equivalent consumption will be assessed before the implant and one year aferwards.
Intervention code [1] 295246 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298872 0
pain ratings on a visual analogue scale
Timepoint [1] 298872 0
one year post stimulation implantation procedure
Secondary outcome [1] 325506 0
Disability score on the Oswestry Disability Scale
Timepoint [1] 325506 0
one year post stimulation implantation procedure
Secondary outcome [2] 325507 0
satisfaction rating on a 1-5 numerical scale
Timepoint [2] 325507 0
one year post stimulation implantation procedure
Secondary outcome [3] 325508 0
Patients will self-report consumption of opioid drugs at each clinical review. A morphine equivalent consumption score before and one year after the stimulator is implanted will be calculated using the OPIOID CONVERSION to oral MORPHINE EQUIVALENT DAILY DOSE Toolkit http://www.hnehealth.nsw.gov.au/Pain/Documents/FPM_opioid_conversion_20141.pdf
Timepoint [3] 325508 0
one year post stimulation implantation procedure

Eligibility
Key inclusion criteria
All patients at Dr Finch’s pain practice who were implanted with a high frequency electrical nerve stimulator (Nevro high frequency stimulator and electrode leads, TGA certificate DV-2011-MC-00182-3) between 1st January 2013 and 1st February 2017 will be invited to be included in the clinical audit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
All patients who were implanted with a Nevro high frequency stimulator and electrode leads (TGA certificate DV-2011-MC-00182-3) between 1st January 2013 and 1st February 2017 will be invited to participate in the clinical audit. Analysis of variance will be used to investigate changes from before to after stimulator implantation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2016
Actual
15/08/2016
Date of last participant enrolment
Anticipated
Actual
9/10/2017
Date of last data collection
Anticipated
11/08/2017
Actual
9/10/2017
Sample size
Target
65
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294014 0
Self funded/Unfunded
Name [1] 294014 0
Dr Philip Finch
Country [1] 294014 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, 6150 WA
Country
Australia
Secondary sponsor category [1] 292834 0
Individual
Name [1] 292834 0
Philip Finch
Address [1] 292834 0
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151 WA
Country [1] 292834 0
Australia
Other collaborator category [1] 279071 0
Individual
Name [1] 279071 0
Peter Drummond
Address [1] 279071 0
Murdoch University, 90 South Street Murdoch 6150 WA
Country [1] 279071 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295426 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 295426 0
90 South Street, Murdoch 6150 WA
Ethics committee country [1] 295426 0
Australia
Date submitted for ethics approval [1] 295426 0
05/07/2016
Approval date [1] 295426 0
11/08/2016
Ethics approval number [1] 295426 0
2016/133

Summary
Brief summary
This study is a clinical audit of patients undergoing implantation of a commercially-available and TGA-approved high frequency stimulator (TGA certificate DV-2011-MC-00182-3) between 1st January 2013 and 1st February 2017 for the clinical management of pain. The study will be a two-year audit of pain scores, disability index, analgesic drug consumption and patient satisfaction after implantation of a high frequency electrical nerve stimulator. Each patient will provide their informed consent for their data to be included in the clinical audit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67186 0
Dr Philip Finch
Address 67186 0
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151 WA
Country 67186 0
Australia
Phone 67186 0
+61 8 93672233
Fax 67186 0
Email 67186 0
pfinch@iinet.net.au
Contact person for public queries
Name 67187 0
Dr Philip Finch
Address 67187 0
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151 WA
Country 67187 0
Australia
Phone 67187 0
+61 8 93672233
Fax 67187 0
Email 67187 0
pfinch@iinet.net.au
Contact person for scientific queries
Name 67188 0
Dr Philip Finch
Address 67188 0
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151 WA
Country 67188 0
Australia
Phone 67188 0
+61 8 93672233
Fax 67188 0
Email 67188 0
pfinch@iinet.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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