Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

February 22, 2021 updated by: Eugene Mironer, M.D., Carolinas Center for Advanced Management of Pain
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • United States
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Carolinas Center for Advanced Management of Pain

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: program 1
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
Device: preset program
Change to different present program using epidural and peripheral lead to cover pain
Other Names:
  • epidural and peripheral lead to cover pain (Spinal Cord Stimulator)
Active Comparator: program 2
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
Device: preset program
Change to different present program using epidural and peripheral lead to cover pain
Other Names:
  • epidural and peripheral lead to cover pain (Spinal Cord Stimulator)
Active Comparator: program 3
preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
Device: preset program
Change to different present program using epidural and peripheral lead to cover pain
Other Names:
  • epidural and peripheral lead to cover pain (Spinal Cord Stimulator)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (Pain)
Time Frame: Weeks 4, 6 and 8
0 (no pain)- 10 (worst pain imaginable)
Weeks 4, 6 and 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.
Time Frame: weeks 4, 6, and 8
percentage of pain relief- self report
weeks 4, 6, and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carolinas Center for Advanced Management of Pain

Collaborators

Abbott Medical Devices

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

September 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7175

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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