Pain perception evaluation with paresthesia independent spinal cord stimulation therapy

evro Corp (USA)0 sites20 target enrollmentJuly 27, 2016

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: evro Corp (USA)
Enrollment: 20
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 27, 2016

End Date

March 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

evro Corp (USA)

Eligibility Criteria

Inclusion Criteria

•1\. Diagnosed with failed back surgery syndrome with predominant back pain
•2\. Average back pain intensity of \= 5 out of 10 on the Numeric Rating Scale (NRS) at enrollment
•3\. An appropriate candidate for Spinal Cord Stimulation as per the Belgian regulations
•4\. An adult (\= 18 years of age) at time of enrollment
•5\. Evaluated at the investigational site at least once prior to screen for the pain condition related to the study
•6\. Willing and capable of giving written informed consent prior to any investigational related procedure
•7\. Willing and able to comply with study\-related requirements, assessments and visits
•8\. Capable of subjective evaluation, able to read and understand written questionnaires, and able to read, understand and sign the written inform consent (Dutch and French)
•9\. Adequate cognitive ability to use a patient external trial stimulator and recharger as determined by the Investigator
•10\. An appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician and if applicable per the local regulations

Exclusion Criteria

•1\. Using an daily opioid dose of \>60mg oral morphine equivalents (meq) or daily \>25 µg/hr transdermal fentanyl
•2\. A 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
•3\. Evidence of an active disruptive psychological or 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 psychologist
•4\. 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
•5\. A visceral pain in the area being treated
•6\. A current diagnosis of a coagulation disorder, Complex Regional Pain Syndrome (CRPS), bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
•7\. A diagnosis of scoliosis that precludes lead placement
•8\. Recent evidence (imaging or letter neurosurgeon) of spinal instability requiring fusion (imaging such as flexion/extension films of lumbar spine is required for this determination and must have been done within the past 6 months)
•9\. Pain that is significantly exacerbated by activity or significantly alleviated by rest
•10\. Benefiting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain