- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284411
Spinal Cord Stimulation (SCS) Dosing Study
April 6, 2020 updated by: MedtronicNeuro
This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This feasibility study assessed the following outcomes:
- Patient satisfaction
- VAS pain scores
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
-
Chandler, Arizona, United States, 85224
- Arizona Pain Doctors
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Georgia
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Lawrenceville, Georgia, United States, 30046
- Georgia Pain and Wellness Center
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Indiana
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Evansville, Indiana, United States, 47714
- Global Scientific Innovations
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Indianapolis, Indiana, United States, 46202
- Goodman Campbell Brain and Spine
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Kentucky
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Louisville, Kentucky, United States, 40241
- Kentuckiana Pain Specialists
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Somerset, Kentucky, United States, 42503
- Drez One, LLC
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Missouri
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Cape Girardeau, Missouri, United States, 63701
- Regional Brain & Spine
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Texas
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Tyler, Texas, United States, 75701
- Precision Spine Care
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Washington
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Spokane, Washington, United States, 99201
- Northwest Pain Care, Inc.
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 22 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Spinal Cord Stimulation
Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude
|
Programming
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SCS Therapy Satisfaction
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
Time Frame: 8 weeks
|
To characterize the effect of four different amplitude settings on baseline pain relief.
During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable.
The higher VAS pain score represented worse pain.
The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis.
Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period.
The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief.
The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2017
Primary Completion (ACTUAL)
March 15, 2019
Study Completion (ACTUAL)
March 15, 2019
Study Registration Dates
First Submitted
August 31, 2017
First Submitted That Met QC Criteria
September 12, 2017
First Posted (ACTUAL)
September 15, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 15, 2020
Last Update Submitted That Met QC Criteria
April 6, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT17046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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