Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

• Sponsor: Bioness Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01592344
• Collaborator: (none)
• Enrollment: 94
• Locations: 13
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether the StimRouter (SR) electrical stimulation therapy leads to clinically important pain relief in patients with chronic intractable pain of peripheral nerve origin after three months of treatment. At the same time, this study will gather information on side effects associated with the StimRouter electrical stimulation therapy.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: StimRouter - active stimulation; Device: StimRouter - Control	N/A

Detailed Description

Ninety (minimum) up to one hundred twenty-six (126) adult (≥ 22 years) subjects who have severe intractable chronic pain of peripheral nerve origin associated with post traumatic/post surgical neuralgia persisting for 3 months or longer and an average chronic pain level of at least 5 on a 0-10 numeric rating scale, where such pain is attributable to a lesion or disease of the somatosensory nervous system, will be recruited from U.S. outpatient physical medicine and rehabilitation clinics.

After screening, subjects who were confirmed to be eligible for the study and provided informed consent will have a pain level assessment period for approximately one week then come back for the Baseline/Implantation visit. Subjects will be trained on and required to complete a patient diary of pain intensity level for at least 7 consecutive days prior to baseline. The randomization and programming will take place approximately two weeks after implantation. Subjects in the treatment group will receive electrical stimulation and pain medication. In contrast, subjects in the parallel control group will receive control stimulation and pain medication.

The plan is to have the parallel portion of the study run for approximately 12 weeks (or 3 months) after randomization for efficacy analysis. Subjects in the control group will be allowed to cross over to the treatment group for nine months of electrical stimulation; the subjects in the treatment group will have nine additional months of stimulation treatment such that safety data will be collected throughout a full twelve month period on all available subjects. While the end of the study is approximately 12 months after randomization, as previously stated, the efficacy analyses will be based on the data collected at the end of the 3-month follow-up evaluation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Prospective, Multi-Center, Randomized, Double-Blinded, Study to Assess Safety and Efficacy of the Bioness® StimRouter™ Neuromodulation System in Patients With Chronic Pain of Peripheral Nerve Origin
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: StimRouter - active stimulation 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.	Device: 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; Other Names: Bioness® StimRouter™ Neuromodulation System
Sham Comparator: StimRouter - Control 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.	Device: 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; Other Names: Bioness® StimRouter™ Neuromodulation System

Outcome Measures

Primary Outcome Measures

1. Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30% [Baseline and at 3-month follow-up.]

   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.

Secondary Outcome Measures

1. Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC). [at 3 month follow-up]

   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).

2. Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3. [at baseline and 3 month follow-up]

   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.

3. Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey [at the 3-month follow-up]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adults (≥ 22 years) suitable for an implanted electrode for pain relief.

2. Subjects who are able to give informed consent and to understand and comply with study requirements.

3. Subjects who have severe intractable chronic pain of peripheral nerve origin associated with post traumatic/post surgical neuralgia for ≥ 3 months (i.e., intractable to pain medication).

4. Subjects who are able to tolerate skin surface stimulation (TENS).

5. Subjects who have a worst chronic pain level in the last 24 hours ≥ 5/10 (on 0-10 NRS) where such pain is attributable to a lesion or disease of the somatosensory nervous system.

6. Subjects who are on a stable dose of pain medications for at least four weeks prior to screening and willing and able to maintain an equivalent dosage of their current pain medications from randomization to 3-month follow-up.

Exclusion Criteria:

1. Subjects who are not willing and able to maintain stable dosages of their pain medications from randomization to 3-month follow-up.

2. Subjects with a pain condition that could be confused with their peripheral neuropathic pain or that is more severe than their peripheral neuropathic pain.

3. Subjects who, for implantation in the trunk, have an implanted demand-type cardiac pacemaker or defibrillator.

4. Subjects who have a metal implant in the area for StimRouter implantation without Sponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) between the StimRouter system and all other active implanted devices and metallic implants.

5. Subjects who require, or are likely to require, diathermy at the implant site.

6. Subjects who require, or are likely to require, therapeutic ultrasound at the implant site.

7. Subjects who have a cancerous lesion present near the target stimulation point or near to where the StimRouter user patch will adhere.

8. Subjects who are known or suspected to have a nickel allergy.

9. Subjects with bleeding disorders or active anticoagulation that cannot be stopped for a few days close to the time of the surgical procedure.

10. Subjects who decline to provide written consent or follow-up.

11. Subjects who are pregnant, plan on becoming pregnant, or are breastfeeding during the study period. Subjects who are female of child-bearing potential must have a negative pregnancy test at baseline visit and, if sexually active, must be using a medically acceptable method of contraception for the duration of the study participation.

12. Subjects who have an active systemic infection or are immunocompromised.

13. Subjects who have an active or existing skin disorder or irritation, which, at the physician's discretion, precludes the use of skin gel electrodes.

14. Subjects who currently require or are likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone: the entire StimRouter lead must be at least 50 cm from the center of the MR system's bore (the iso-center) and at least 16 cm outside of the MR coil measured from the edge of the MR coil.

15. Subjects who have a history of adverse reactions to local anesthetic (e.g., lidocaine).

16. Subjects who are participating in any other study that could affect the outcome of the StimRouter study, such as a spinal stimulation study, without Sponsor approval.

17. Subjects who are in litigation or who have pending or an active worker's compensation claim.

18. Subjects with less than one year of life expectancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Pain Specialists	Scottsdale	Arizona	United States	85258
2	Neurovations	Napa	California	United States	94558
3	Neuro-Therapeutics, Inc.	Pasadena	California	United States	91105
4	The Spine Institute, Center for Spinal Restoration	Santa Monica	California	United States	90403
5	Holy Cross Orthopedic Institute	Fort Lauderdale	Florida	United States	33334
6	Shands Jacksonville Medical Center, Dept of Neurology Research	Jacksonville	Florida	United States	32209
7	Millennium Pain Center	Bloomington	Illinois	United States	61701
8	Premier Pain Centers, LLC	Shrewsbury	New Jersey	United States	07702
9	The Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
10	Cleveland Clinic	Cleveland	Ohio	United States	44195
11	Virginia Mason Medical Center	Seattle	Washington	United States	98101
12	Center for Pain Relief, St. Francis Hospital	Charleston	West Virginia	United States	25301
13	The Center for Pain Relief at St. Mary's Medical Center	Huntington	West Virginia	United States	25702

Sponsors and Collaborators

• Bioness Inc

Investigators

• Study Director: Linh Nguyen, MS, Bioness Inc
• Principal Investigator: Ramsin Benyamin, M.D., Millennium Pain Center
• Study Chair: Timothy Deer, M.D., Center for Pain Relief, St. Francis Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MedlinePlus related topics: Chronic pain
• US FDA Recourses

Publications

None provided.

• Responsible Party: Bioness Inc
• ClinicalTrials.gov Identifier: NCT01592344
• Other Study ID Numbers: CP-STMR11-001
• First Posted: May 7, 2012
• Last Update Posted: Apr 11, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Bioness Inc: Chronic pain; peripheral nerve; neuralgia; somatosensory nervous system
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Arm/Group Title	Active Stimulation Treatment	Control
Arm/Group Description	Subjects implanted with the StimRouter lead and randomized to receive active stimulation.	Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
Period Title: Overall Study
STARTED	45	49
COMPLETED	41	44
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Active Stimulation Treatment	Control	Total
Arm/Group Description	Subjects implanted with the StimRouter lead and randomized to receive active stimulation.	Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.	Total of all reporting groups
Overall Participants	45	49	94
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.8 (10.0)	53.2 (12.1)	53.0 (11.1)
Sex: Female, Male (Count of Participants)
Female	25 55.6%	30 61.2%	55 58.5%
Male	20 44.4%	19 38.8%	39 41.5%
Region of Enrollment (participants) [Number]
United States	45 100%	49 100%	94 100%

Outcome Measures

1. Primary Outcome

Title	Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%
Description	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.
Time Frame	Baseline and at 3-month follow-up.

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population was analyzed.

Arm/Group Title	StimRouter - Active Stimulation	StimRouter - Control
Arm/Group Description	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- 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
Measure Participants	45	49
Number [participants]	17 37.8%	5 10.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	StimRouter - Active Stimulation, StimRouter - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0048
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

2. Secondary Outcome

Title	Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).
Description	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).
Time Frame	at 3 month follow-up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	StimRouter - Active Stimulation	StimRouter - Control
Arm/Group Description	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- 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
Measure Participants	41	45
Mean (Standard Deviation) [units on a scale]	4.8 (1.5)	2.5 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	StimRouter - Active Stimulation, StimRouter - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.
Description	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.
Time Frame	at baseline and 3 month follow-up

Outcome Measure Data

Analysis Population Description

All available data were analyzed from both treatment arms.

Arm/Group Title	StimRouter - Active Stimulation	StimRouter - Control
Arm/Group Description	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- 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
Measure Participants	41	45
Mean (Standard Deviation) [units on a scale]	-2.4 (2.3)	-0.3 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	StimRouter - Active Stimulation, StimRouter - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey
Description	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.
Time Frame	at the 3-month follow-up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	StimRouter - Active Stimulation	StimRouter - Control
Arm/Group Description	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- 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
Measure Participants	41	45
Mean (Standard Deviation) [units on a scale]	7.3 (2.9)	3.0 (3.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	StimRouter - Active Stimulation, StimRouter - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Adverse events were reported throughout the one year study period.
Adverse Event Reporting Description	No device related serious adverse events were reported.
Arm/Group Title	StimRouter Active Stimulation		StimRouter Control
Arm/Group Description	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		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
All Cause Mortality
	StimRouter Active Stimulation		StimRouter Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	StimRouter Active Stimulation		StimRouter Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/45 (20%)		11/49 (22.4%)
Cardiac disorders
heart arrhythmia	1/45 (2.2%)	1	1/49 (2%)	1
Gastrointestinal disorders
Digestive issues	0/45 (0%)	0	2/49 (4.1%)	2
Hepatobiliary disorders
gall bladder	1/45 (2.2%)	1	2/49 (4.1%)	2
Infections and infestations
dermatological issues	1/45 (2.2%)	1	2/49 (4.1%)	2
Metabolism and nutrition disorders
Dehydration	0/45 (0%)	0	1/49 (2%)	1
Musculoskeletal and connective tissue disorders
Bone fracture, instability, compromise	3/45 (6.7%)	5	3/49 (6.1%)	3
Renal and urinary disorders
Kidney failure and bladder tumor	3/45 (6.7%)	4	0/49 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory issues	2/45 (4.4%)	2	0/49 (0%)	0
Other (Not Including Serious) Adverse Events
	StimRouter Active Stimulation		StimRouter Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/45 (42.2%)		16/49 (32.7%)
Gastrointestinal disorders
Gastrointestinal	3/45 (6.7%)	5	3/49 (6.1%)	5
General disorders
headache	2/45 (4.4%)	4	0/49 (0%)	0
Medicine wthdrawn in error	1/45 (2.2%)	1	0/49 (0%)	0
Infections and infestations
Infection	1/45 (2.2%)	1	2/49 (4.1%)	3
Injury, poisoning and procedural complications
Fall/bruising	0/45 (0%)	0	2/49 (4.1%)	3
Metabolism and nutrition disorders
Dehydration	1/45 (2.2%)	1	0/49 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal	4/45 (8.9%)	6	7/49 (14.3%)	18
Psychiatric disorders
Psychiatric	0/45 (0%)		1/49 (2%)	2
Renal and urinary disorders
renal	3/45 (6.7%)	3	2/49 (4.1%)	2
Reproductive system and breast disorders
Sexual dysfunction	1/45 (2.2%)	1	0/49 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory	2/45 (4.4%)	3	1/49 (2%)	2
Skin and subcutaneous tissue disorders
Localized pain irritation to patch/wound site	15/45 (33.3%)	33	16/49 (32.7%)	26
Lead exposure	1/45 (2.2%)	2	0/49 (0%)	0

Limitations/Caveats

The device was designed for treatment of mononeuritis excluding the face. For this reason, mononeuropathies of the face were excluded.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.