RecruitingNot ApplicableNCT05741788

The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain


Sponsor

University of Minnesota

Enrollment

15 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 Years

Inclusion Criteria4

  • years of age or older
  • Scheduled to undergo spinal cord stimulation
  • English speaker
  • Baseline pain rating (NRS/VAS) >=6

Exclusion Criteria7

  • Scheduled for permanent implantation only without trial
  • Presence of pacemakers or other neurostimulators
  • Pregnant
  • Inability to read or use smart phone
  • Individuals who are unable to consent
  • Employees or students of PI
  • Prisoners

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Interventions

DEVICEVarious Stimulation Patterns

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. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT05741788


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