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Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Primary Purpose

Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

preset program

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring back pain, neuromodulation, spinal peripheral neuromodulation, spinal cord stimulation, postlaminectomy pain syndrome

Eligibility Criteria

22 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Carolinas Center For Advanced Management of Pain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

program 1

program 2

program 3

Arm Description

preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs

Outcomes

Primary Outcome Measures

Numeric Rating Scale (Pain)

0 (no pain)- 10 (worst pain imaginable)

Secondary Outcome Measures

Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.

percentage of pain relief- self report

Full Information

NCT ID

NCT02346383

First Posted

October 15, 2013

Last Updated

February 22, 2021

Sponsor

Carolinas Center for Advanced Management of Pain

Collaborators

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT02346383

Brief Title

Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Official Title

Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Carolinas Center for Advanced Management of Pain

Collaborators

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

back pain, neuromodulation, spinal peripheral neuromodulation, spinal cord stimulation, postlaminectomy pain syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

program 1

Arm Type

Active Comparator

Arm Description

preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs

Arm Title

program 2

Arm Type

Active Comparator

Arm Description

preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs

Arm Title

program 3

Arm Type

Active Comparator

Arm Description

preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs

Intervention Type

Device

Intervention Name(s)

preset program

Other Intervention Name(s)

epidural and peripheral lead to cover pain (Spinal Cord Stimulator)

Intervention Description

Change to different present program using epidural and peripheral lead to cover pain

Primary Outcome Measure Information:

Title

Numeric Rating Scale (Pain)

Description

0 (no pain)- 10 (worst pain imaginable)

Time Frame

Weeks 4, 6 and 8

Secondary Outcome Measure Information:

Title

Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.

Description

percentage of pain relief- self report

Time Frame

weeks 4, 6, and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Carolinas Center For Advanced Management of Pain

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

12. IPD Sharing Statement

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Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

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