The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Chronic Pain
• Interventions: Device: Various Stimulation Patterns

• Registration Number: NCT05741788
• Lead Sponsor: University of Minnesota

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

Not available

Study Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-10-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Various Stimulation Patterns	Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.

Primary Outcome Measures

Name	Time	Method
Feasibility	3 years	Feasibility as measured by total study procedure completion rate.

Secondary Outcome Measures

Name	Time	Method
Acceptability of procedure	3 years	Acceptability as measured by the average patient rating and their acceptability of the study based on their experience during the procedures across study procedures. Participants rate their overall experience with the procedures used during the study on a scale from 0 as 'Excellent' to 4 as 'Very Poor'.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States