ACTRN12612000350820
Terminated
未知
A Multicentre Prospective Observational Study on the Safety and Efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients
evro Corporation0 sites50 target enrollmentMarch 27, 2012
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- evro Corporation
- Enrollment
- 50
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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