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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Various Stimulation Patterns
DeviceParticipants 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
Trial outcomes
Primary outcomes
Feasibility
Feasibility as measured by total study procedure completion rate.
Secondary outcomes
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'.
Sponsors and contacts
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