Trial Outcomes & Findings for Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation (NCT NCT01550562)

NCT ID: NCT01550562

Last Updated: 2021-04-29

Results Overview

Mean within-patient difference in average back pain intensity among treatment groups

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 4,8,and 12 days post temporary lead(s) implantation
• Results posted on: 2021-04-29

Participant Flow

1 subject was enrolled in this study.

Participant milestones

Measure	Randomized Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2).
First Intervention, 4 - 5 Days STARTED	1
First Intervention, 4 - 5 Days COMPLETED	1
First Intervention, 4 - 5 Days NOT COMPLETED	0
Second Intervention, 4 - 5 Days STARTED	1
Second Intervention, 4 - 5 Days COMPLETED	1
Second Intervention, 4 - 5 Days NOT COMPLETED	0
Third Intervention, 4 - 5 Days STARTED	1
Third Intervention, 4 - 5 Days COMPLETED	1
Third Intervention, 4 - 5 Days NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation

Baseline characteristics by cohort

Measure	Randomized n=1 Participants Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment Australia	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 4,8,and 12 days post temporary lead(s) implantation

Population: No study data are available.

Mean within-patient difference in average back pain intensity among treatment groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4,8,and 12 days post temporary lead(s) implantation

Population: No study data are available.

Difference in the proportion of subjects with ≥50% reduction in average back pain intensity among treatment groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4,8,and 12 days post temporary lead(s) implantation

Population: No study data are available.

Mean within-patient difference in average leg pain intensity among treatment groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4,8,and 12 days post temporary lead(s) implantation

Population: No study data are available.

Mean within-patient difference in disability among treatment groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4,8,and 12 days post temporary lead(s) implantation

Population: No study data are available.

Mean within-patient difference in overall percent pain relief among treatment groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4,8,and 12 days post temporary lead(s) implantation

Population: No study data are available.

Mean within-patient difference in quality of life among treatment groups

Outcome measures

Outcome data not reported

Adverse Events

Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Research Sciences

Boston Scientific

Phone: 6619494350

Email: roshini.jain@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place