Expired Study
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Spartanburg, South Carolina 29303


Purpose:

To determine the best parameters with various leads to cover back and leg pain and provide best pain relief


Study summary:

Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS and stimulator data, changes to program #2. The visit @ week 6 collect NRS and stimulator data, and starts program #3. The visit @ week 8 collects NRS and stimulator data. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS and stimulator data and final study visit information.


Criteria:

Inclusion Criteria: - spinal cord stimulator implant within last 3 weeks - NRS > 6 - at least 22 years old - patients who agree not to add or increase their pain medications during the study Exclusion Criteria: - patients with prior spinal cord stimulators - pregnancy - infusion pump - history of substance abuse or dependency in last 6 months


Study is Available At:


Original ID:

7175


NCT ID:

NCT02346383


Secondary ID:


Study Acronym:


Brief Title:

Optimal Stimulation Programming for Spinal Peripheral Neuromodulation


Official Title:

Optimal Stimulation Programming for Spinal Peripheral Neuromodulation


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

22 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Carolinas Center for Advanced Management of Pain


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

42


Enrollment Type:

Actual


Study Dates

Start Date:September 2013
Completion Date:June 2016
Completion Type:Actual
Primary Completion Date:May 2016
Primary Completion Type:Actual
Verification Date:July 2017
Last Changed Date:July 19, 2017
First Received Date:October 15, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Numeric Rating Scale (Pain)
Time Frame:week 2 - baseline
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Numeric Rating Scale (Pain)
Time Frame:Week 4
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Numeric Rating Scale (Pain)
Time Frame:Week 6
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Numeric Rating Scale (Pain)
Time Frame:Week 8
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Numeric Rating Scale (Pain)
Time Frame:week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:percent pain relief
Time Frame:week 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:percent pain relief
Time Frame:week 6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:percent pain relief
Time Frame:week 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:percent pain relief
Time Frame:week 12
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:preset program
Description:Change to different present program using epidural and peripheral lead to cover pain
Arm Name:program 1
Other Name:epidural and peripheral lead to cover pain (Spinal

Study Arms

Study Arm Type:Active Comparator
Arm Name:program 2
Description:preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
Study Arm Type:Active Comparator
Arm Name:program 3
Description:preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
Study Arm Type:Active Comparator
Arm Name:program 1
Description:preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Carolinas Center for Advanced Management of Pain
Agency Class:Industry
Agency Type:Collaborator
Agency Name:St. Jude Medical

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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