Spinal Cord Stimulation (SCS) Dosing Study
1 other identifier
interventional
30
1 country
10
Brief Summary
This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2017
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2017
CompletedFirst Posted
Study publicly available on registry
September 15, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedResults Posted
Study results publicly available
March 18, 2020
CompletedApril 15, 2020
April 1, 2020
1.4 years
August 31, 2017
March 3, 2020
April 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
SCS Therapy Satisfaction
To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: "Overall how satisfied or unsatisfied are you with this therapy?". The response choices were as follows: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", "very unsatisfied". Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response "very satisfied", "somewhat satisfied", or "neutral", otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.
8 weeks
Secondary Outcomes (1)
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
8 weeks
Study Arms (1)
Spinal Cord Stimulation
EXPERIMENTALEach subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older
- Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month
- Has approproate SCS settings
- Willing and able to provide signed and dated informed consent
- Capable of comprehending and consenting in English
- Capable of getting into the supine and sitting positions
- Willing and able to comply with all study procedures and visits
- On stable (no change in dose, route, or frequency) prescribed pain medications
You may not qualify if:
- Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system
- Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study
- Implanted with quadripolar lead
- Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study
- Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
- Has untreated major psychiatric comorbidity
- Has serious drug-related behavioral issues
- Has unresolved major issues of secondary gain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (10)
Arizona Pain Doctors
Chandler, Arizona, 85224, United States
Georgia Pain and Wellness Center
Lawrenceville, Georgia, 30046, United States
Global Scientific Innovations
Evansville, Indiana, 47714, United States
Goodman Campbell Brain and Spine
Indianapolis, Indiana, 46202, United States
Kentuckiana Pain Specialists
Louisville, Kentucky, 40241, United States
Drez One, LLC
Somerset, Kentucky, 42503, United States
Regional Brain & Spine
Cape Girardeau, Missouri, 63701, United States
Precision Spine Care
Tyler, Texas, 75701, United States
Northwest Pain Care, Inc.
Spokane, Washington, 99201, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SCS Dosing Clinical Research Study Team
- Organization
- Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2017
First Posted
September 15, 2017
Study Start
November 1, 2017
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
April 15, 2020
Results First Posted
March 18, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share