Trial Outcomes & Findings for OPTIONS Spinal Cord Stimulation Programming Parameters (NCT NCT02503787)
NCT ID: NCT02503787
Last Updated: 2017-09-19
Results Overview
Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).
COMPLETED
NA
64 participants
From baseline to 3 months post device activation
2017-09-19
Participant Flow
All enrolled subjects will undergo a Spinal Cord Stimulation device trial that includes an intraoperative programming trial. Subjects experiencing a positive response (improvement in average overall pain relief) during the trial will move forward with a permanent implant. Those not reporting a positive response will be exited from the study.
Participant milestones
| Measure |
Open Label Treatment
Spinal Cord Stimulation (SCS)
|
|---|---|
|
Enrollment
STARTED
|
64
|
|
Enrollment
COMPLETED
|
44
|
|
Enrollment
NOT COMPLETED
|
20
|
|
Device Trial (HD Programming Trial)
STARTED
|
44
|
|
Device Trial (HD Programming Trial)
COMPLETED
|
37
|
|
Device Trial (HD Programming Trial)
NOT COMPLETED
|
7
|
|
Successful Trial (≥50% Pain Relief)
STARTED
|
37
|
|
Successful Trial (≥50% Pain Relief)
COMPLETED
|
32
|
|
Successful Trial (≥50% Pain Relief)
NOT COMPLETED
|
5
|
|
Implant to 3 Month Endpoint
STARTED
|
32
|
|
Implant to 3 Month Endpoint
COMPLETED
|
29
|
|
Implant to 3 Month Endpoint
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Open Label Treatment
Spinal Cord Stimulation (SCS)
|
|---|---|
|
Enrollment
Withdrawal by Subject
|
6
|
|
Enrollment
Inclusion/exclusion criteria not met
|
4
|
|
Enrollment
Physician Decision
|
2
|
|
Enrollment
Insurance issue
|
2
|
|
Enrollment
Lost to Follow-up
|
1
|
|
Enrollment
Study closure
|
1
|
|
Enrollment
Adverse Event
|
1
|
|
Enrollment
Protocol Violation
|
1
|
|
Enrollment
Inability to implant system
|
1
|
|
Enrollment
Unable to be programmed
|
1
|
|
Device Trial (HD Programming Trial)
Lack of Efficacy
|
6
|
|
Device Trial (HD Programming Trial)
Withdrawal by Subject
|
1
|
|
Successful Trial (≥50% Pain Relief)
Withdrawal by Subject
|
3
|
|
Successful Trial (≥50% Pain Relief)
Physician Decision
|
2
|
|
Implant to 3 Month Endpoint
Adverse Event
|
2
|
|
Implant to 3 Month Endpoint
Withdrawal by Subject
|
1
|
Baseline Characteristics
OPTIONS Spinal Cord Stimulation Programming Parameters
Baseline characteristics by cohort
| Measure |
Open Label Treatment
n=32 Participants
Spinal Cord Stimulation (SCS)
|
|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
|
Average Overall Pain
|
7.5 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 3 months post device activationSelf reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).
Outcome measures
| Measure |
Open Label Treatment
n=32 Participants
Spinal Cord Stimulation (SCS)
|
|---|---|
|
Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
|
-3.7 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: From baseline to 3 months post device activationEvaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference).
Outcome measures
| Measure |
Open Label Treatment
n=32 Participants
Spinal Cord Stimulation (SCS)
|
|---|---|
|
Patient Global Impression of Change
7 - A great deal better
|
10 Participants
|
|
Patient Global Impression of Change
6 - Better
|
12 Participants
|
|
Patient Global Impression of Change
5 - Moderately better
|
6 Participants
|
|
Patient Global Impression of Change
4 - Somewhat better
|
1 Participants
|
|
Patient Global Impression of Change
3 - A little better
|
1 Participants
|
|
Patient Global Impression of Change
2 - Almost the same
|
2 Participants
|
|
Patient Global Impression of Change
1 - No change (or worse)
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 3 months post device activationSelf reported daily average back pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).
Outcome measures
| Measure |
Open Label Treatment
n=32 Participants
Spinal Cord Stimulation (SCS)
|
|---|---|
|
Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
|
-3.8 units on a scale
Standard Deviation 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 3 months post device activationSelf reported daily average leg pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).
Outcome measures
| Measure |
Open Label Treatment
n=32 Participants
Spinal Cord Stimulation (SCS)
|
|---|---|
|
Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
|
-4.1 units on a scale
Standard Deviation 2.7
|
Adverse Events
Device: Neurostimulator
Serious adverse events
| Measure |
Device: Neurostimulator
n=48 participants at risk
RestoreSensor SureScan MRI Rechargeable Neurostimulator
RestoreSensor SureScan MRI Rechargeable Neurostimulator: RestoreSensor SureScan MRI Rechargeable Neurostimulator
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/48 • Number of events 1 • Adverse events were collected beginning at the device trialing procedure and throughout implant and the 3 month activation phase.
The sample for adverse event reporting is the 48 subjects who initiated the device trialing procedure (44 subjects started the HD programming trial). Device, therapy, and/or procedure-related adverse events were collected. Adverse events that were documented as the reason for discontinuation were also collected regardless of etiology.
|
Other adverse events
| Measure |
Device: Neurostimulator
n=48 participants at risk
RestoreSensor SureScan MRI Rechargeable Neurostimulator
RestoreSensor SureScan MRI Rechargeable Neurostimulator: RestoreSensor SureScan MRI Rechargeable Neurostimulator
|
|---|---|
|
Nervous system disorders
Paraesthesia (uncomfortable sensation)
|
14.6%
7/48 • Number of events 9 • Adverse events were collected beginning at the device trialing procedure and throughout implant and the 3 month activation phase.
The sample for adverse event reporting is the 48 subjects who initiated the device trialing procedure (44 subjects started the HD programming trial). Device, therapy, and/or procedure-related adverse events were collected. Adverse events that were documented as the reason for discontinuation were also collected regardless of etiology.
|
|
General disorders
Implant site warmth
|
10.4%
5/48 • Number of events 5 • Adverse events were collected beginning at the device trialing procedure and throughout implant and the 3 month activation phase.
The sample for adverse event reporting is the 48 subjects who initiated the device trialing procedure (44 subjects started the HD programming trial). Device, therapy, and/or procedure-related adverse events were collected. Adverse events that were documented as the reason for discontinuation were also collected regardless of etiology.
|
|
General disorders
Pain
|
6.2%
3/48 • Number of events 3 • Adverse events were collected beginning at the device trialing procedure and throughout implant and the 3 month activation phase.
The sample for adverse event reporting is the 48 subjects who initiated the device trialing procedure (44 subjects started the HD programming trial). Device, therapy, and/or procedure-related adverse events were collected. Adverse events that were documented as the reason for discontinuation were also collected regardless of etiology.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restrictions on the PI allow for the sponsor to review results communications prior to public release and to embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to sponsor for review. The sponsor is also allowed to require changes for technical correctness and to protect confidential information, copyrightable or patentable material; and when reasonably requested, extend the embargo up to an additional 90 days.
- Publication restrictions are in place
Restriction type: OTHER