Back to resultsSpinal Cord Stimulation (SCS) Dosing Study
Primary Purpose
Back Pain, Leg Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain
Eligibility Criteria
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
Sites / Locations
- Arizona Pain Doctors
- Georgia Pain and Wellness Center
- Global Scientific Innovations
- Goodman Campbell Brain and Spine
- Kentuckiana Pain Specialists
- Drez One, LLC
- Regional Brain & Spine
- Precision Spine Care
- Northwest Pain Care, Inc.
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal Cord Stimulation
Arm Description
Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03284411
Brief Title
Spinal Cord Stimulation (SCS) Dosing Study
Official Title
Spinal Cord Stimulation (SCS) Dosing Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.
Detailed Description
This feasibility study assessed the following outcomes:
Patient satisfaction
VAS pain scores
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Leg Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation
Intervention Description
Programming
Primary Outcome Measure Information:
Title
SCS Therapy Satisfaction
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Arizona Pain Doctors
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Georgia Pain and Wellness Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Global Scientific Innovations
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Goodman Campbell Brain and Spine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Kentuckiana Pain Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Drez One, LLC
City
Somerset
State/Province
Kentucky
ZIP/Postal Code
42503
Country
United States
Facility Name
Regional Brain & Spine
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Northwest Pain Care, Inc.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Spinal Cord Stimulation (SCS) Dosing Study
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