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NCT02346383 Clinical Trial

Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Chronic Pain Clinical Trial

Official title:
Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02346383
Other study ID # 7175
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date June 2016

Study information
Verified date February 2021
Source Carolinas Center for Advanced Management of Pain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• preset program
Change to different present program using epidural and peripheral lead to cover pain

Locations
Country Name City State
United States Carolinas Center For Advanced Management of Pain Spartanburg South Carolina

Sponsors (2)
Lead Sponsor Collaborator
Carolinas Center for Advanced Management of Pain Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Numeric Rating Scale (Pain) 0 (no pain)- 10 (worst pain imaginable) Weeks 4, 6 and 8
Secondary Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. percentage of pain relief- self report weeks 4, 6, and 8
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