SCS for the Treatment Of Chronic Pain of the Upper Extremities (UEP)
Primary Purpose
Upper Extremity Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Senza
Sponsored by
About this trial
This is an interventional treatment trial for Upper Extremity Pain
Eligibility Criteria
Key Inclusion Criteria:
- Have been diagnosed with chronic, intractable pain of an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
- Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
- Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
- Be 18 years of age or older at the time of enrollment.
- Be an appropriate candidate for the surgical procedures required in this study.
- Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
- Have stable neurological status measured by motor, sensory and reflex function.
Key Exclusion Criteria:
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures.
- Have a current diagnosis of a progressive neurological disease.
- Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
- Have mechanical spine instability as determined.
- Have significant stenosis, based on MRI.
- Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
- Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
- Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
- Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
- Be involved in an injury claim under current litigation.
- Have a pending or approved worker's compensation claim.
- Have 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.
Sites / Locations
- NEVRO Corp
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Senza
Arm Description
Spinal Cord Stimulation for UEP
Outcomes
Primary Outcome Measures
Responder Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02703818
Brief Title
SCS for the Treatment Of Chronic Pain of the Upper Extremities
Acronym
UEP
Official Title
Multi-Center, Prospective, Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment Of Chronic Pain of the Upper Extremities
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nevro Corp
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, multi-center post-market study of the Senza System in subjects with chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Senza
Arm Type
Experimental
Arm Description
Spinal Cord Stimulation for UEP
Intervention Type
Device
Intervention Name(s)
Senza
Intervention Description
Spinal Cord Stimulation
Primary Outcome Measure Information:
Title
Responder Rate
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Have been diagnosed with chronic, intractable pain of an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
Be 18 years of age or older at the time of enrollment.
Be an appropriate candidate for the surgical procedures required in this study.
Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
Have stable neurological status measured by motor, sensory and reflex function.
Key Exclusion Criteria:
Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures.
Have a current diagnosis of a progressive neurological disease.
Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
Have mechanical spine instability as determined.
Have significant stenosis, based on MRI.
Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
Be involved in an injury claim under current litigation.
Have a pending or approved worker's compensation claim.
Have 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Caraway, MD
Organizational Affiliation
Nevro Corp
Official's Role
Study Director
Facility Information:
Facility Name
NEVRO Corp
City
Redwood City
State/Province
California
ZIP/Postal Code
94065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33204145
Citation
Burgher A, Kosek P, Surrett S, Rosen SM, Bromberg T, Gulve A, Kansal A, Wu P, McRoberts WP, Udeshi A, Esposito M, Gliner BE, Maneshi M, Rotte A, Subbaroyan J. Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study. J Pain Res. 2020 Nov 10;13:2837-2851. doi: 10.2147/JPR.S278661. eCollection 2020.
Results Reference
derived
Learn more about this trial
SCS for the Treatment Of Chronic Pain of the Upper Extremities
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