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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12612000350820
Ethics application status
Approved
Date submitted
20/03/2012
Date registered
27/03/2012
Date last updated
11/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
An observational study on the safety and efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome patients
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Scientific title
A Multicentre Prospective Observational Study on the Safety and Efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients
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Secondary ID [1]
280150
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None
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Universal Trial Number (UTN)
U1111-1129-2859
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Trial acronym
HF SCS for CRPS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Complex Regional Pain Syndrome of the upper limbs
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Complex Regional Pain Syndrome of the lower limbs
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Condition category
Condition code
Musculoskeletal
286268
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0
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Other muscular and skeletal disorders
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Anaesthesiology
286310
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0
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Pain management
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Evaluation of pain relief, functional capacity and quality of life improvements from baseline and their evolution over a 12 month period
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Intervention code [1]
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Not applicable
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Comparator / control treatment
Pain relief at 12 months compared to baseline
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Pain relief at 12 months compared to baseline as assessed using VAS score
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Improvement in affected limb function compared at 3, 6, 9 and 12 months to baseline as assessed by handgrip strength test for upper limb and 6-minute walking test and foot range motion for lower limb CRPS subjects
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Assessment method [1]
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Timepoint [1]
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3, 6 9 and 12 months
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Secondary outcome [2]
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Changes in pain quality and symptoms over time, as assessed using the Short-Form McGill Pain Quesionnaire (SF-MPQ-2)
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Assessment method [2]
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Improvement of quality of life at 3, 6, 9 and 12 months compared to baseline, as assessed using the SF-36 questionnaire
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Assessment method [3]
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Timepoint [3]
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3, 6, 9 and 12 months
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Secondary outcome [4]
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Changes in depressive status Life at 3, 6, 9 and 12 months compared to baseline, as assessed using the CES-D quesionnaire
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Assessment method [4]
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Timepoint [4]
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3, 6, 9 and 12 months
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Secondary outcome [5]
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Patient Global Impression of Change (PGIC)
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Assessment method [5]
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Timepoint [5]
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3, 6, 9 and 12 months
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Secondary outcome [6]
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Percentage of patients able to return to work at 3, 6, 9 and 12 months based on a questionnaire of the subject's work status
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Assessment method [6]
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Timepoint [6]
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3, 6, 9 and 12 months
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Secondary outcome [7]
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Reduction in analgesic use based on a review of the subject's prescribed medications at 3, 6, 9 and 12 months compared to baseline
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Assessment method [7]
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Timepoint [7]
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3, 6, 9 and 12 months
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Eligibility
Key inclusion criteria
Diagnosed with CRPS according to the Budapest research diagnostic criteria
Symptoms for more than 6 months and less than 5 years
Failed conservative management for 3 months
Average pain intensity of at least 5cm out of 10cm in the 30 days prior to the Baseline Visit (based on the baseline visit VAS)
Over 18 years of age
Able to provide informed consent and willing to comply with study procedures
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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
Contra-indication to the implantation of an SCS system
Medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints
Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical spinal stenosis
Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by a psychiatrist
Female patients that are pregnant or are planning to become pregnant over the next 12 months
Life expectancy of lesss than 1 year
Inability to manage the technical demands of the SCS equipment
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
9/04/2012
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Actual
1/10/2012
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Date of last participant enrolment
Anticipated
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Actual
1/10/2016
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Date of last data collection
Anticipated
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Actual
1/11/2017
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Sample size
Target
50
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Nevro Medical Pty Ltd
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Address [1]
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Level 6
468 St Kilda Road
Melbourne
Victoria 3004
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Nevro Corporation
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Address
4040 Campbell Avenue, Suite 210
Menlo Park
CA 94025
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
283799
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Limited
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Ethics committee address [1]
286959
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Ethics committee country [1]
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Date submitted for ethics approval [1]
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22/03/2012
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Approval date [1]
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09/04/2012
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Ethics approval number [1]
286959
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Summary
Brief summary
The purpose of this study is to evaluate the safety, efficacy and patient acceptance of High Frequency (HF) Spinal Cord Stimulation (SCS) for the treatment of patients with chronic neuropathic pain due to Complex Regional Pain Syndrome (CRPS). Main study endpoints will assess pain relief, functional capacity and quality of life improvements over a 12 month period.
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Trial website
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Trial related presentations / publications
Oral/poster presentations at national and international congresses: North American Neuromodulation Society (NANS) http://www.neuromodulation.org/Meetings/NANS-Annual-Meeting/nansannualmeeting.html; International Neuromodulation Society (INS), INS - Australian Chapter http://www.neuromodulation.com/ins-congress; Publications in peer-reviewed journals: Neuromodulation http://wiley.com/bw/journal.asp?ref=1094-7159&site=1 ; Pain Medicine http://www.wiley.com./bw/journal.asp?ref=1526-2375
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Public notes
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Contacts
Principal investigator
Name
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Dr Marc Russo
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Address
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Hunter Clinical Research
220 Denison Street
Broadmeadow NSW 2292
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Country
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Australia
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Phone
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+61 2 49851860
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Melinda Goldman
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Address
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Hunter Clinical Research
220 Denison Street
Broadmeadow NSW 2292
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Country
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Australia
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Phone
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+61 (0)2 4985 1860
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Fax
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+61 (0)2 4962 2046
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Claire Smith
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Address
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Level 6
468 St Kilda Road
Melbourne
Victoria 3004
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Country
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Australia
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Phone
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+61 (0) 416511161
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Fax
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Email
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Results availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials: Comparing the RReADS, RReACT, and RReMiT databases.
2015
https://dx.doi.org/10.1016/j.pain.0000000000000009
N.B. These documents automatically identified may not have been verified by the study sponsor.
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