SCS Research Study

Not Applicable

Terminated

• Conditions: Trunk Pain; Limb Pain
• Interventions: Device: Spinal Cord Stimulation

• Registration Number: NCT03763708
• Lead Sponsor: MedtronicNeuro

Brief Summary

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

Detailed Description

This post market study will measure the following:

* Numeric Pain Rating Scale

* Satisfaction and Stimulation Assessment

* Stimulation feedback

* Stimulation parameters

* Anatomical locations of active contacts

* Stimulation thresholds

* Location of paresthesia

* Oswestry Disability Index

* European Quality of Life 5-Dimensions

* To characterize non-invasive health monitoring data

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2018-12-12
• Primary Completion: 2023-01-13
• Study Completion: 2023-01-13
• Status Verified: 2024-12
• Results First Submitted: 2024-12-09
• Results First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Results First Posted: 2024-12-31
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation	Spinal Cord Stimulation	Each subject will be programmed to different settings.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS) - Cohort 1	Up to 5 months	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.
Numeric Pain Rating Scale (NPRS) - Cohort 2	Up to 2 months	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.
Numeric Pain Rating Scale (NPRS) - Cohort 3	Up to 3 months	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.
Numeric Pain Rating Scale (NPRS) - Cohort 4	Up to 5 months	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.
Numeric Pain Rating Scale - Cohort 5	Up to 5 months	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.
Numeric Pain Rating Scale (NPRS) - Cohort 6	Up to 7 months	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.
Numeric Pain Rating Scale (NPRS) - Cohort 7	Up to 8 months	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.
Numeric Pain Rating Scale (NPRS) - Cohort 8	Up to 0.5 months	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.
Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9	Up to 1 month	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.

Trial Locations

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

Regional Brain and Spine; 🇺🇸 Cape Girardeau, Missouri, United States

Center for Interventional Pain and Spine; 🇺🇸 Lancaster, Pennsylvania, United States

Carolinas Research Institute; 🇺🇸 Huntersville, North Carolina, United States

Pain Diagnostics and Interventional Care; 🇺🇸 Sewickley, Pennsylvania, United States

Northwest Pain Care; 🇺🇸 Spokane, Washington, United States

Twin Cities Pain Clinic; 🇺🇸 Edina, Minnesota, United States