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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StimRouter - active stimulation | Experimental | 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. |
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| StimRouter - Control | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StimRouter - active stimulation | Device | The stimulation program settings for this arm are as follows: Stim Settings
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| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30% | 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. | Baseline and at 3-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC). | 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). | at 3 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linh Nguyen, MS | Bioness Inc | Study Director |
| Ramsin Benyamin, M.D. | Millennium Pain Center | Principal Investigator |
| Timothy Deer, M.D. | Center for Pain Relief, St. Francis Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pain Specialists | Scottsdale | Arizona | 85258 | United States | ||
| Neurovations |
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| Label | URL |
|---|---|
| MedlinePlus related topics: Chronic pain | View source |
| US FDA Recourses | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Stimulation Treatment | Subjects implanted with the StimRouter lead and randomized to receive active stimulation. |
| FG001 | Control | Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| StimRouter - Control | Device | The stimulation program settings for this arm are as follows: Stim Settings
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| Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3. | 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. | at baseline and 3 month follow-up |
| Patient Satisfaction Will be Assessed Using a Patient 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. | at the 3-month follow-up |
| Napa |
| California |
| 94558 |
| United States |
| Neuro-Therapeutics, Inc. | Pasadena | California | 91105 | United States |
| The Spine Institute, Center for Spinal Restoration | Santa Monica | California | 90403 | United States |
| Holy Cross Orthopedic Institute | Fort Lauderdale | Florida | 33334 | United States |
| Shands Jacksonville Medical Center, Dept of Neurology Research | Jacksonville | Florida | 32209 | United States |
| Millennium Pain Center | Bloomington | Illinois | 61701 | United States |
| Premier Pain Centers, LLC | Shrewsbury | New Jersey | 07702 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Center for Pain Relief, St. Francis Hospital | Charleston | West Virginia | 25301 | United States |
| The Center for Pain Relief at St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Adults having severe intractable chronic pain of peripheral nerve origin were enrolled and all were included in the 94 intent-to-treat analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Stimulation Treatment | Subjects implanted with the StimRouter lead and randomized to receive active stimulation. |
| BG001 | Control | Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30% | 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. | Intent to treat (ITT) population was analyzed. | Posted | Number | participants | Baseline and at 3-month follow-up. |
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| Secondary | Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC). | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | at 3 month follow-up |
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| Secondary | Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3. | 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. | All available data were analyzed from both treatment arms. | Posted | Mean | Standard Deviation | units on a scale | at baseline and 3 month follow-up |
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| Secondary | Patient Satisfaction Will be Assessed Using a Patient 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | at the 3-month follow-up |
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Adverse events were reported throughout the one year study period.
No device related serious adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | StimRouter Active Stimulation | The stimulation program settings for the active stimulation arm are as follows: Stim Settings
| 9 | 45 | 19 | 45 | ||
| EG001 | StimRouter Control | The stimulation program settings for the control arm are as follows: Stim Settings
| 11 | 49 | 16 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart arrhythmia | Cardiac disorders | Non-systematic Assessment | Unrelated to device |
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| Kidney failure and bladder tumor | Renal and urinary disorders | Non-systematic Assessment | unrelated to device |
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| gall bladder | Hepatobiliary disorders | Non-systematic Assessment | cholelithiasis and cholecystectomy not device related |
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| Bone fracture, instability, compromise | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Knee replacement, rotator cuff repair, spine instability/leak, bone fracture all unrelated to device |
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| Respiratory issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | unrelated to device: pneumonia, breathing problems |
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| Digestive issues | Gastrointestinal disorders | Non-systematic Assessment | diverticulitis not device related |
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| dermatological issues | Infections and infestations | Non-systematic Assessment | unrelated abscess, cellulitis, infection, |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | unrelated dehydration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Localized pain irritation to patch/wound site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment | diarrhea, diverticulitis, nausea |
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| renal | Renal and urinary disorders | Non-systematic Assessment | kidney stone, urinary tract infection, kidney function |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | flu, cough |
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| Infection | Infections and infestations | Non-systematic Assessment | sinusitis |
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| Psychiatric | Psychiatric disorders | Non-systematic Assessment | confusion, dementia |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Joint spine issues |
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| Fall/bruising | Injury, poisoning and procedural complications | Non-systematic Assessment | Falling due to frailty |
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| Sexual dysfunction | Reproductive system and breast disorders | Non-systematic Assessment | Delayed ejaculation |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| headache | General disorders | Non-systematic Assessment |
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| Medicine wthdrawn in error | General disorders | Non-systematic Assessment |
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| Lead exposure | Skin and subcutaneous tissue disorders | Non-systematic Assessment | lead implanted too superficially, skin scratched by patient until lead became exposed requiring repositioning of lead |
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The device was designed for treatment of mononeuritis excluding the face. For this reason, mononeuropathies of the face were excluded.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charlene Myers, Contractor | Bioness | 9499101655 | cahanderson@msn.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Male |
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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
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