Chronic PainNCT01592344
Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy
A study testing StimRouter - active stimulation in people with Chronic Pain, run by Bioness Inc at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- StimRouter - active stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 22 years) suitable for an implanted electrode for pain relief.
- Subjects who are able to give informed consent and to understand and comply with study requirements.
- 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).
- Subjects who are able to tolerate skin surface stimulation (TENS).
- 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.
- 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.
Who cannot join
- Subjects who are not willing and able to maintain stable dosages of their pain medications from randomization to 3-month follow-up.
- Subjects with a pain condition that could be confused with their peripheral neuropathic pain or that is more severe than their peripheral neuropathic pain.
- Subjects who, for implantation in the trunk, have an implanted demand-type cardiac pacemaker or defibrillator.
- 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.
- Subjects who require, or are likely to require, diathermy at the implant site.
- Subjects who require, or are likely to require, therapeutic ultrasound at the implant site.
Show all 18Show fewer
- Subjects who have a cancerous lesion present near the target stimulation point or near to where the StimRouter user patch will adhere.
- Subjects who are known or suspected to have a nickel allergy.
- Subjects with bleeding disorders or active anticoagulation that cannot be stopped for a few days close to the time of the surgical procedure.
- Subjects who decline to provide written consent or follow-up.
- 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.
- Subjects who have an active systemic infection or are immunocompromised.
- Subjects who have an active or existing skin disorder or irritation, which, at the physician's discretion, precludes the use of skin gel electrodes.
- 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.
- Subjects who have a history of adverse reactions to local anesthetic (e.g., lidocaine).
- 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.
- Subjects who are in litigation or who have pending or an active worker's compensation claim.
- Subjects with less than one year of life expectancy.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Millennium Pain Center
Bloomington, Illinois, 61701
Center for Pain Relief, St. Francis Hospital
Charleston, West Virginia, 25301
Cleveland Clinic
Cleveland, Ohio, 44195
Holy Cross Orthopedic Institute
Fort Lauderdale, Florida, 33334
The Center for Pain Relief at St. Mary's Medical Center
Huntington, West Virginia, 25702
Shands Jacksonville Medical Center, Dept of Neurology Research
Jacksonville, Florida, 32209
Neurovations
Napa, California, 94558
Neuro-Therapeutics, Inc.
Pasadena, California, 91105
The Spine Institute, Center for Spinal Restoration
Santa Monica, California, 90403
Arizona Pain Specialists
Scottsdale, Arizona, 85258
Virginia Mason Medical Center
Seattle, Washington, 98101
Premier Pain Centers, LLC
Shrewsbury, New Jersey, 07702
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- StimRouter - active stimulation, StimRouter - Control
- Keywords
- Chronic pain, peripheral nerve, neuralgia, somatosensory nervous system
- Medical subject headings
- Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimRouter - active stimulationDevice
Also called Bioness® StimRouter™ Neuromodulation System
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 - ControlDevice
Also called Bioness® StimRouter™ Neuromodulation System
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: StimRouter - active stimulation |
| 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. Receives: Device: StimRouter - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 3-month follow-up.
Secondary outcomes (3)
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).
Measured: at 3 month follow-up
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.
Measured: 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.
Measured: at the 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioness Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linh Nguyen, MS, Study director, Bioness IncRamsin Benyamin, M.D., Principal investigator, Millennium Pain CenterTimothy Deer, M.D., Study chair, Center for Pain Relief, St. Francis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592344
- Sponsor's protocol ID
- CP-STMR11-001
- Status last verified
- Mar 2016
- First submitted
- 3 May 2012
- Last updated
- 11 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01592344
- Acronym / sponsor ID
- CP-STMR11-001
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, peripheral nerve, neuralgia, somatosensory nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bioness IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StimRouter - active stimulation | Experimental | Device: StimRouter - active stimulationStimRouter- 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 - Control | Sham comparator | Device: StimRouter - ControlStimRouter- 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥ 22 years) suitable for an implanted electrode for pain relief.
- Subjects who are able to give informed consent and to understand and comply with study requirements.
- 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).
- Subjects who are able to tolerate skin surface stimulation (TENS).
- 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.
Key exclusion criteria (18 listed)
- Subjects who are not willing and able to maintain stable dosages of their pain medications from randomization to 3-month follow-up.
- Subjects with a pain condition that could be confused with their peripheral neuropathic pain or that is more severe than their peripheral neuropathic pain.
- Subjects who, for implantation in the trunk, have an implanted demand-type cardiac pacemaker or defibrillator.
- 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.
- Subjects who require, or are likely to require, diathermy at the implant site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimRouter - active stimulationAlso: Bioness® StimRouter™ Neuromodulation SystemThe 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 | Device | StimRouter - active stimulation |
| StimRouter - ControlAlso: Bioness® StimRouter™ Neuromodulation SystemThe 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 | Device | StimRouter - Control |
Primary outcome
Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%
Time frame: 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.
3 secondary outcomes
Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).
Time frame: at 3 month follow-up
Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.
Time frame: at baseline and 3 month follow-up
Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey
Time frame: at the 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MedlinePlus related topics: Chronic painLink provided by the sponsor.
- US FDA RecoursesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linh Nguyen, MS study director
Bioness Inc
Ramsin Benyamin, M.D. principal investigator
Millennium Pain Center
Timothy Deer, M.D. study chair
Center for Pain Relief, St. Francis Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StimRouter - active stimulation in people with Chronic Pain, run by Bioness Inc at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30% (time frame: Baseline and at 3-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.