Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: preset program

• Registration Number: NCT02346383
• Lead Sponsor: Carolinas Center for Advanced Management of Pain

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-27
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Results First Submitted: 2018-02-01
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Results First Posted: 2021-03-16
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
program 1	preset program	preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
program 2	preset program	preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
program 3	preset program	preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (Pain)	Weeks 4, 6 and 8	0 (no pain)- 10 (worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.	weeks 4, 6, and 8	percentage of pain relief- self report

Trial Locations

Locations (1)

Carolinas Center For Advanced Management of Pain; 🇺🇸 Spartanburg, South Carolina, United States