Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Carolinas Center for Advanced Management of Pain

Status: Completed

Conditions: Chronic Pain

Treatments: Device: preset program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02346383

7175

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 22 to 90 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

40 participants in 3 patient groups

program 1

Active Comparator group

Description:

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

Treatment:

Device: preset program

program 2

Active Comparator group

Description:

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

Treatment:

Device: preset program

program 3

Active Comparator group

Description:

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

Treatment:

Device: preset program