Trial Review

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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
Scientific title
A Multicentre Prospective Observational Study on the Safety and Efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients
Secondary ID [1] 280150 0
None
Universal Trial Number (UTN)
U1111-1129-2859
Trial acronym
HF SCS for CRPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex Regional Pain Syndrome of the upper limbs 286072 0
Complex Regional Pain Syndrome of the lower limbs 286073 0
Condition category
Condition code
Musculoskeletal 286268 286268 0 0
Other muscular and skeletal disorders
Anaesthesiology 286310 286310 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 284479 0
Not applicable
Comparator / control treatment
Pain relief at 12 months compared to baseline
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286772 0
Pain relief at 12 months compared to baseline as assessed using VAS score
Timepoint [1] 286772 0
12 months
Secondary outcome [1] 296620 0
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
Timepoint [1] 296620 0
3, 6 9 and 12 months
Secondary outcome [2] 296621 0
Changes in pain quality and symptoms over time, as assessed using the Short-Form McGill Pain Quesionnaire (SF-MPQ-2)
Timepoint [2] 296621 0
12 months
Secondary outcome [3] 296622 0
Improvement of quality of life at 3, 6, 9 and 12 months compared to baseline, as assessed using the SF-36 questionnaire
Timepoint [3] 296622 0
3, 6, 9 and 12 months
Secondary outcome [4] 296623 0
Changes in depressive status Life at 3, 6, 9 and 12 months compared to baseline, as assessed using the CES-D quesionnaire
Timepoint [4] 296623 0
3, 6, 9 and 12 months
Secondary outcome [5] 296624 0
Patient Global Impression of Change (PGIC)
Timepoint [5] 296624 0
3, 6, 9 and 12 months
Secondary outcome [6] 296625 0
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
Timepoint [6] 296625 0
3, 6, 9 and 12 months
Secondary outcome [7] 296626 0
Reduction in analgesic use based on a review of the subject's prescribed medications at 3, 6, 9 and 12 months compared to baseline
Timepoint [7] 296626 0
3, 6, 9 and 12 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
9/04/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
1/10/2016
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
50
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284926 0
Commercial sector/Industry
Name [1] 284926 0
Nevro Medical Pty Ltd
Country [1] 284926 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nevro Corporation
Address
4040 Campbell Avenue, Suite 210
Menlo Park
CA 94025
Country
United States of America
Secondary sponsor category [1] 283799 0
None
Name [1] 283799 0
Address [1] 283799 0
Country [1] 283799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286959 0
Bellberry Limited
Ethics committee address [1] 286959 0
Ethics committee country [1] 286959 0
Date submitted for ethics approval [1] 286959 0
22/03/2012
Approval date [1] 286959 0
09/04/2012
Ethics approval number [1] 286959 0

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.
Trial website
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
Public notes

Contacts
Principal investigator
Name 33930 0
Dr Marc Russo
Address 33930 0
Hunter Clinical Research
220 Denison Street
Broadmeadow NSW 2292
Country 33930 0
Australia
Phone 33930 0
+61 2 49851860
Fax 33930 0
Email 33930 0
pi@hunterclinicalresearch.com.au
Contact person for public queries
Name 17177 0
Mrs Melinda Goldman
Address 17177 0
Hunter Clinical Research
220 Denison Street
Broadmeadow NSW 2292
Country 17177 0
Australia
Phone 17177 0
+61 (0)2 4985 1860
Fax 17177 0
+61 (0)2 4962 2046
Email 17177 0
admin@hunterclinicalresearch.com.au
Contact person for scientific queries
Name 8105 0
Ms Claire Smith
Address 8105 0
Level 6
468 St Kilda Road
Melbourne
Victoria 3004
Country 8105 0
Australia
Phone 8105 0
+61 (0) 416511161
Fax 8105 0
Email 8105 0
smith@nevrocorp.com

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
SourceTitleYear of PublicationDOI
EmbaseResults availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials: Comparing the RReADS, RReACT, and RReMiT databases.2015https://dx.doi.org/10.1016/j.pain.0000000000000009
N.B. These documents automatically identified may not have been verified by the study sponsor.