Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach

1 country

9 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

First Submitted

Initial submission to the registry

December 3, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed

8 days until next milestone

Study Start

First participant enrolled

December 12, 2018

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed

2 years until next milestone

Results Posted

Study results publicly available

December 31, 2024

Completed

Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

4.1 years

First QC Date

December 3, 2018

Results QC Date

December 9, 2024

Last Update Submit

December 9, 2024

Conditions

Limb Pain Trunk Pain

Outcome Measures

Primary Outcomes (9)

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.
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.
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.
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.
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.
Up to 5 months
Numeric Pain Rating Scale (NPRS) - Cohort 6
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.
Up to 7 months
Numeric Pain Rating Scale (NPRS) - Cohort 7
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.
Up to 8 months
Numeric Pain Rating Scale (NPRS) - Cohort 8
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.
Up to 0.5 months
Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9
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.
Up to 1 month