← Back to all trials
Not Yet Recruiting
NCT05741788
The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
Conditions: Spinal Cord Injuries, Chronic Pain
Sex: All
Ages: 22 Years – N/A
Phase: NA
Enrollment: 15
Sponsor: University of Minnesota
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:22 years of age or olderScheduled to undergo spinal cord stimulationEnglish speakerBaseline pain rating (NRS/VAS) >=6Exclusion Criteria:Scheduled for permanent implantation only without trialPresence of pacemakers or other neurostimulatorsPregnantInability to read or use smart phoneIndividuals who are unable to consentEmployees or students of PIPrisoners
Source: ClinicalTrials.gov (NCT05741788). StuddyBuddy aggregates publicly available trial information.