An observational study on the safety and efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome patients

Not Applicable

• Conditions: Complex Regional Pain Syndrome of the upper limbs; Complex Regional Pain Syndrome of the lower limbs; Musculoskeletal - Other muscular and skeletal disorders; Anaesthesiology - Pain management

• Registration Number: ACTRN12612000350820
• Lead Sponsor: evro Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Observational
• Study Design: Not specified