Trial Outcomes & Findings for Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy (NCT NCT01592344)
NCT ID: NCT01592344
Last Updated: 2016-04-11
Results Overview
The average pain at rest was assessed using a numerical (0-10) rating scale (NRS) on the Brief Pain Inventory (BPI) Short Form (SF). A higher score indicates worse pain (10=worst pain imaginable) and zero indicates 'no pain at all'. A pain reduction of greater than or equal to 30% on the NRS was considered to be clinically relevant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
Baseline and at 3-month follow-up.
Results posted on
2016-04-11
Participant Flow
Participant milestones
| Measure |
Active Stimulation Treatment
Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
|
Control
Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
49
|
|
Overall Study
COMPLETED
|
41
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Active Stimulation Treatment
Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
|
Control
Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
not available at primary outcome visit
|
2
|
4
|
Baseline Characteristics
Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy
Baseline characteristics by cohort
| Measure |
Active Stimulation Treatment
n=45 Participants
Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
|
Control
n=49 Participants
Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
49 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 3-month follow-up.Population: Intent to treat (ITT) population was analyzed.
The average pain at rest was assessed using a numerical (0-10) rating scale (NRS) on the Brief Pain Inventory (BPI) Short Form (SF). A higher score indicates worse pain (10=worst pain imaginable) and zero indicates 'no pain at all'. A pain reduction of greater than or equal to 30% on the NRS was considered to be clinically relevant.
Outcome measures
| Measure |
StimRouter - Active Stimulation
n=45 Participants
StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.
StimRouter - active stimulation: The stimulation program settings for this arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 100-250 µsec
* Pulse Rate: 50-100 Hz
* Intensity: 0-30mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
StimRouter - Control
n=49 Participants
StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.
StimRouter - Control: The stimulation program settings for this arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 200 µsec
* Pulse Rate: 1 Hz
* Intensity: 0 mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
|---|---|---|
|
Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%
|
17 participants
|
5 participants
|
SECONDARY outcome
Timeframe: at 3 month follow-upPopulation: All patients who completed the 3 month Global Impression of Change questionnaire were included. Four patients in each study arm failed to complete the questionnaire.
Patient Global Impression of Change in activity limitations, symptoms, emotions and overall life quality related to their painful condition (Range 1 to 7, with 1 indicating no change and 7 indicating a great deal better/considerable improvement).
Outcome measures
| Measure |
StimRouter - Active Stimulation
n=41 Participants
StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.
StimRouter - active stimulation: The stimulation program settings for this arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 100-250 µsec
* Pulse Rate: 50-100 Hz
* Intensity: 0-30mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
StimRouter - Control
n=45 Participants
StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.
StimRouter - Control: The stimulation program settings for this arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 200 µsec
* Pulse Rate: 1 Hz
* Intensity: 0 mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
|---|---|---|
|
Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).
|
4.8 units on a scale
Standard Deviation 1.5
|
2.5 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: at baseline and 3 month follow-upPopulation: All available data were analyzed from both treatment arms.
Worst pain in the last 24 hours assessed using 7-day patient pain diary scores for BPI ranging from 0 to 10, with 0 indicating no pain and 10 indicating "pain as bad as you can imagine". Change from baseline to Month 3 was compared.
Outcome measures
| Measure |
StimRouter - Active Stimulation
n=41 Participants
StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.
StimRouter - active stimulation: The stimulation program settings for this arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 100-250 µsec
* Pulse Rate: 50-100 Hz
* Intensity: 0-30mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
StimRouter - Control
n=45 Participants
StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.
StimRouter - Control: The stimulation program settings for this arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 200 µsec
* Pulse Rate: 1 Hz
* Intensity: 0 mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
|---|---|---|
|
Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.
|
-2.4 units on a scale
Standard Deviation 2.3
|
-0.3 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: at the 3-month follow-upPopulation: All subjects who completed the survey at Month 3 were included in this analysis. Four subjects in each study arm (4/45 Treatment; 4/49 Control) failed to complete the satisfaction survey.
Patient satisfaction with the StimRouter System was rated on a numerical rating scale (range 0 to 10), with 0 indicating not satisfied at all and 10 indicating completely satisfied.
Outcome measures
| Measure |
StimRouter - Active Stimulation
n=41 Participants
StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.
StimRouter - active stimulation: The stimulation program settings for this arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 100-250 µsec
* Pulse Rate: 50-100 Hz
* Intensity: 0-30mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
StimRouter - Control
n=45 Participants
StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.
StimRouter - Control: The stimulation program settings for this arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 200 µsec
* Pulse Rate: 1 Hz
* Intensity: 0 mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
|---|---|---|
|
Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey
|
7.3 units on a scale
Standard Deviation 2.9
|
3.0 units on a scale
Standard Deviation 3.6
|
Adverse Events
StimRouter Active Stimulation
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
StimRouter Control
Serious events: 11 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
StimRouter Active Stimulation
n=45 participants at risk
The stimulation program settings for the active stimulation arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 100-250 µsec
* Pulse Rate: 50-100 Hz
* Intensity: 0-30mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
StimRouter Control
n=49 participants at risk
The stimulation program settings for the control arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 200 µsec
* Pulse Rate: 1 Hz
* Intensity: 0 mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
|---|---|---|
|
Cardiac disorders
heart arrhythmia
|
2.2%
1/45 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
2.0%
1/49 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Renal and urinary disorders
Kidney failure and bladder tumor
|
6.7%
3/45 • Number of events 4 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
0.00%
0/49 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Hepatobiliary disorders
gall bladder
|
2.2%
1/45 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
4.1%
2/49 • Number of events 2 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Bone fracture, instability, compromise
|
6.7%
3/45 • Number of events 5 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
6.1%
3/49 • Number of events 3 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory issues
|
4.4%
2/45 • Number of events 2 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
0.00%
0/49 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Gastrointestinal disorders
Digestive issues
|
0.00%
0/45 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
4.1%
2/49 • Number of events 2 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Infections and infestations
dermatological issues
|
2.2%
1/45 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
4.1%
2/49 • Number of events 2 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/45 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
2.0%
1/49 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
Other adverse events
| Measure |
StimRouter Active Stimulation
n=45 participants at risk
The stimulation program settings for the active stimulation arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 100-250 µsec
* Pulse Rate: 50-100 Hz
* Intensity: 0-30mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
StimRouter Control
n=49 participants at risk
The stimulation program settings for the control arm are as follows:
Stim Settings
* Waveform: Symmetric or Asymmetric
* Phase Duration: 200 µsec
* Pulse Rate: 1 Hz
* Intensity: 0 mA Time Settings
* Constant Stim: On
* Total Time: 6 hour
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
8.9%
4/45 • Number of events 6 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
14.3%
7/49 • Number of events 18 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Localized pain irritation to patch/wound site
|
33.3%
15/45 • Number of events 33 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
32.7%
16/49 • Number of events 26 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Gastrointestinal disorders
Gastrointestinal
|
6.7%
3/45 • Number of events 5 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
6.1%
3/49 • Number of events 5 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Renal and urinary disorders
renal
|
6.7%
3/45 • Number of events 3 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
4.1%
2/49 • Number of events 2 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
4.4%
2/45 • Number of events 3 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
2.0%
1/49 • Number of events 2 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Infections and infestations
Infection
|
2.2%
1/45 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
4.1%
2/49 • Number of events 3 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Psychiatric disorders
Psychiatric
|
0.00%
0/45 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
2.0%
1/49 • Number of events 2 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Injury, poisoning and procedural complications
Fall/bruising
|
0.00%
0/45 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
4.1%
2/49 • Number of events 3 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
2.2%
1/45 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
0.00%
0/49 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/45 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
0.00%
0/49 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
General disorders
headache
|
4.4%
2/45 • Number of events 4 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
0.00%
0/49 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
General disorders
Medicine wthdrawn in error
|
2.2%
1/45 • Number of events 1 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
0.00%
0/49 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
Lead exposure
|
2.2%
1/45 • Number of events 2 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
0.00%
0/49 • Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60