The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

University of Minnesota (UMN)

Status: Enrolling

Conditions: Spinal Cord Injuries; Chronic Pain

Treatments: Device: Various Stimulation Patterns

Study type: Interventional

Funder types: Other

Identifiers

NCT05741788

Teaspoon

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Experimental group

Experimental group

Description:

Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.

Treatment:

Device: Various Stimulation Patterns