The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Purpose

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.

Conditions

  • Spinal Cord Injuries
  • Chronic Pain

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental group
Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.
  • Device: Various 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.

Recruiting Locations

University of Minnesota
Minneapolis, Minnesota 55414
Contact:
David Darrow, MD
612-624-6666
darro015@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

David Darrow, MD
612-624-6666
darro015@umn.edu