Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741788
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-01-16
Brief Title:
The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs Spinal cord stimulation has been shown to improve chronic pain improve quality of life and reduce disability Unfortunately spinal cord stimulation has a high trial failure rate and a high long-term failure rate This study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy Participants will undergo a structured optimization evaluating existing types of stimulation tonic burst and multistim Each participant will try out all types of available stimulation but be blinded to the type Over the course of four months each participant will evaluate each type of stimulation by reporting daily pain scores Thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use Participants will follow up routinely to collect laboratory behavioral and survey responses to test for the feasibility of obtaining data explaining pain phenotype
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None