The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorUniversity of Minnesota

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

22 years of age or older

Scheduled to undergo spinal cord stimulation

English speaker

Baseline pain rating (NRS/VAS) >=6

Disqualifiers

Scheduled for permanent implantation only without trial

Presence of pacemakers or other neurostimulators

Pregnant

Inability to read or use smart phone

Trial design

Design model

Single group

Treatments tested in this trial

  • Various Stimulation Patterns

    Device

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility

Feasibility as measured by total study procedure completion rate.

Time frame
3 years

Secondary outcomes

1

Acceptability of procedure

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'.

Time frame
3 years

Other outcomes

Sponsors and contacts

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