NCT03763708 - SCS Research Study | Crick

Overview

To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Limb Pain Trunk Pain

Interventions

Spinal Cord StimulationDEVICE

Programming

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 22 years of age or older 2. Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months 3. Willing and able to provide signed and dated informed consent 4. Capable of comprehending and consenting in English 5. Willing and able to comply with all study procedures, including diary completion, and visits 6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain Exclusion Criteria: 1. Implanted with neurostimulation system for an off-label indication 2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results 3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study 4. Has untreated major psychiatric comorbidity 5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator

Locations (9)

Center for Pain and Supportive Care

Phoenix, Arizona, United States

Goodman Campbell Brain and Spine

Carmel, Indiana, United States

Drez One

Somerset, Kentucky, United States

Twin Cities Pain Clinic

Outcomes

Primary Outcomes

Numeric Pain Rating Scale (NPRS) - Cohort 1

To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.

Time frame: Up to 5 months

Numeric Pain Rating Scale (NPRS) - Cohort 2

To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.

Time frame: Up to 2 months

Numeric Pain Rating Scale (NPRS) - Cohort 3

To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.

Time frame: Up to 3 months

Numeric Pain Rating Scale (NPRS) - Cohort 4

To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.

Time frame: Up to 5 months

Numeric Pain Rating Scale - Cohort 5

To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.