Trial Outcomes & Findings for Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain (NCT NCT01665040)

Results Overview

Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

90-days post permanent implantation

Results posted on

2020-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Neurostimulation for Chronic Pain Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
Overall Study STARTED	40
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neurostimulation for Chronic Pain n=40 Participants Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
Age, Continuous	53.9 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90-days post permanent implantation

Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.

Outcome measures

Outcome measures
Measure	Neurostimulation for Chronic Pain n=40 Participants Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation	32 Participants

PRIMARY outcome

Timeframe: 365 days post permanent implantation

Population: A sub-group of subjects utilizing more than 2 IPG ports at 365 Days post-IPG implantation

Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.

Outcome measures

Outcome measures
Measure	Neurostimulation for Chronic Pain n=21 Participants Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation	21 Participants

Adverse Events

Neurostimulation for Chronic Pain

Serious events: 11 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neurostimulation for Chronic Pain n=40 participants at risk Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
Infections and infestations Infection	12.5% 5/40 • Number of events 5 • 365 days The investigator was responsible for notifying the IRB/IEC of deviations from the CIP, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) occurring at the site, and other SAE/UADE reports received from the Sponsor (BSC) in accordance with local procedures and IRB/IEC requirements.
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective Tissue Disorders	7.5% 3/40 • Number of events 4 • 365 days The investigator was responsible for notifying the IRB/IEC of deviations from the CIP, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) occurring at the site, and other SAE/UADE reports received from the Sponsor (BSC) in accordance with local procedures and IRB/IEC requirements.
Nervous system disorders Nervous System Disorders	7.5% 3/40 • Number of events 4 • 365 days The investigator was responsible for notifying the IRB/IEC of deviations from the CIP, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) occurring at the site, and other SAE/UADE reports received from the Sponsor (BSC) in accordance with local procedures and IRB/IEC requirements.

Other adverse events

Other adverse events
Measure	Neurostimulation for Chronic Pain n=40 participants at risk Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
Injury, poisoning and procedural complications Falls	10.0% 4/40 • Number of events 4 • 365 days The investigator was responsible for notifying the IRB/IEC of deviations from the CIP, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) occurring at the site, and other SAE/UADE reports received from the Sponsor (BSC) in accordance with local procedures and IRB/IEC requirements.

Additional Information

Roshini Jain, Director of Clinical Sciences

Boston Scientific

Phone: 6619494350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place