Chronic PainPSSPNCT03093935
StimRouter™ for Pain Management in Post-stroke Shoulder Pain
A study testing StimRouter Neuromodulation System in people with Chronic Pain and Hemiplegic Shoulder Pain, run by Bioness Inc at 2 sites in United States.
Trial summary
StimRouter Neuromodulation System includes an implanted lead which provides peripheral nerve stimulation for chronic pain. Post-stroke shoulder pain patients will be the focus of this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Hemiplegic Shoulder Pain
- What is being tested?
- StimRouter Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2018to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age ≥18 years and confirmed diagnosis of stroke
- Competent to provide consent and comply with study requirements
- Minimum 3 months of severe chronic focal post-stroke shoulder pain
- Stable regimen of pain medications for >4 weeks prior to implant and willing to maintain equivalent dosage throughout the study
- A mean score of > 4 on the Brief Pain Inventory short form, question 3 (BPI-SF3)
- Capable and willing to follow all study-related procedures
- Able to tolerate surface stimulation as demonstrated by motor level response at shoulder
Who cannot join
- Patients who decline to provide written consent or to attend follow-up visits
- Shoulder pathology (e.g. rotator cuff tear, frozen shoulder etc) at target limb
- Evidence of a primary central or regional pain pattern inclusive of shoulder
- Diagnosed/confirmed shoulder dysfunction
- Botox or other neurolytic agent injections in last 3 months
- Any confounding neurologic conditions affecting the upper limb
Show all 18Show fewer
- Evidence or history of skin infections
- History of adverse reactions to local anesthetics (e.g. lidocaine) or adhesives
- Patients who have an active systemic infection or are immunocompromised
- Patients who are pregnant, intend to become pregnant, are breastfeeding or of child-bearing potential and not practicing a medically-approved method of birth control
- Currently requiring or likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone defined as within 50cm of the iso-center or 16 cm of the MR coil as measured from the edge of the MRI coil.
- Any metallic implant in the immediate area intended for implant (e.g. TSR)
- Has demand-type cardiac pacemaker, defibrillator, or electrical nerve implant
- Potential need for diathermy at the implant site
- Potential need for therapeutic ultrasound at the implant site
- Patients who have already been implanted with StimRouter TM prior to study enrollment
- Presence of a documented condition or abnormality that could compromise the safety of the patient
- Life expectancy of less than 1 year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida, 33136
University of Utah
Salt Lake City, Utah, 84123
About this study
Official title: StimRouter™ Neuromodulation System: Implanted Peripheral Nerve Stimulation for Pain Management When Treating Patients With Chronic Post-stroke Shoulder-pain
StimRouter Neuromodulation System includes an implanted lead which provides peripheral nerve stimulation for chronic pain. Post-stroke shoulder pain patients will be the focus of this study. After meeting inclusion/exclusion criteria, approximately 50 enrolled patients will participate in the study through 6 months of follow-up. Various measures will be used to assess patient response to use of the device.
Read the detailed description
Adults age 18 or over with severe intractable chronic shoulder pain subsequent to stroke will be included. Pain relief will be measured after using StimRouter stimulation therapy targeting the axillary nerve. Existing/pre-study pain medications must be either maintained, reduced throughout the trial.
Study Design is prospective, multi-center and will include 50 subjects The primary endpoint will be a clinically relevant pain reduction (30%) in pain score at 3 months after initiating stimulation in at least 50% of patients with no increase in pain medication.
Primary Outcomes: Reduction of average pain at rest measured by numeric scale (BPI-SF5)
Secondary Outcomes
- Change in Worst Pain (BPI-SF3)
- Least Pain \& Pain Right Now (BPI - SF 4,6)
- Patient Global Impression of Change (PGIC)
- Patient Satisfaction questionnaire
- Shoulder Q Data Collection Points
- Baseline 2) Month 1 post-programming 3) Month 2 post-programming 4) Month 3 post-programming 5) Month 6 post-programming Data Analysis Analyses will be made to evaluate differences in outcomes compared to baseline measures, with primary endpoint at Month 3
- Standard statistical estimation and inference will be undertaken for the observed treatment effect.
- All adverse events will be tabulated by their frequencies and proportions.
- Conditions
- Chronic Pain, Hemiplegic Shoulder Pain
- Being tested
- StimRouter Neuromodulation System
- Keywords
- Post-Stroke, Neuromodulation, Axillary nerve, Peripheral Nerve Stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimRouter Neuromodulation SystemDevice
Also called StimRouter
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
| Study group | Role | What they receive |
|---|---|---|
| StimRouter Neuromodulation System | Experimental | All eligible patients who are enrolled in this study will be treated with StimRouter stimulation therapy as part of standard of care for the entire duration of the study (6 months) and observed for post-market population-specific data.
Standard recommended stimulation parameters for post-stroke shoulder pain include settings to elicit sensory response (paresthesia) as well as motor response (muscle contraction). Receives: Device: StimRouter Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI) Change
The Brief Pain Inventory (BPI) form is a standard pain assessment tool based on a 0 to 10 scale. The Average Pain at Rest (BPI question number 5) score will be assessed at Baseline and approximately 3 months after programming (therapy start) to determine if there is a significant reduction in average pain with the addition of StimRouter TM treatment to standard of care.
Measured: Change from Baseline at Month 3
Secondary outcomes (3)
Patient Global Impression of Change (PGIC) Change
Patient Global Impression of Change (PGIC) survey assesses perceived overall change in a combination of pain and life quality
Measured: Change from Baseline at Month 3
Patient Satisfaction
Patient Satisfaction will be measured by a numeric (i.e., 1-5) rating scale (NRS)
Measured: Month 3
Standardized Shoulder Questionnaire (Shoulder Q) Change
Change in difficulty level (on a scale from 0 to 3) or ability (yes/no) for completing normal day-to-day activities such as combing hair or lifting an 8 pound container to the shoulder level without bending the elbow, as measured by the Shoulder Q standardized questionnaire.
Measured: Change from Baseline at Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Jul 2018
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Why it stopped: Lack of subject participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort- Prospective, multi-center to collect population specific outcome measures in post-stroke patients
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioness Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith McBride, Study chair, Bioness Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093935
- Sponsor's protocol ID
- STMR Pain 002 PSSP
- Acronym
- PSSP
- Status last verified
- Dec 2020
- First submitted
- 18 Mar 2017
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StimRouter™ Neuromodulation System: Implanted Peripheral Nerve Stimulation for Pain Management When Treating Patients With Chronic Post-stroke Shoulder-pain
- ClinicalTrials.gov ID
- NCT03093935
- Acronym / sponsor ID
- PSSP / STMR Pain 002 PSSP
- Conditions
- Chronic Pain, Hemiplegic Shoulder Pain
- Keywords
- Post-Stroke, Neuromodulation, Axillary nerve, Peripheral Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subject participation
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bioness IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
StimRouter Neuromodulation System includes an implanted lead which provides peripheral nerve stimulation for chronic pain. Post-stroke shoulder pain patients will be the focus of this study. After meeting inclusion/exclusion criteria, approximately 50 enrolled patients will participate in the study through 6 months of follow-up. Various measures will be used to assess patient response to use of the device.
Detailed description
Adults age 18 or over with severe intractable chronic shoulder pain subsequent to stroke will be included. Pain relief will be measured after using StimRouter stimulation therapy targeting the axillary nerve. Existing/pre-study pain medications must be either maintained, reduced throughout the trial.
Study Design is prospective, multi-center and will include 50 subjects The primary endpoint will be a clinically relevant pain reduction (30%) in pain score at 3 months after initiating stimulation in at least 50% of patients with no increase in pain medication.
Primary Outcomes: Reduction of average pain at rest measured by numeric scale (BPI-SF5)
Secondary Outcomes
- Change in Worst Pain (BPI-SF3)
- Least Pain \& Pain Right Now (BPI - SF 4,6)
- Patient Global Impression of Change (PGIC)
- Patient Satisfaction questionnaire
- Shoulder Q Data Collection Points
- Baseline 2) Month 1 post-programming 3) Month 2 post-programming 4) Month 3 post-programming 5) Month 6 post-programming Data Analysis Analyses will be made to evaluate differences in outcomes compared to baseline measures, with primary endpoint at Month 3
- Standard statistical estimation and inference will be undertaken for the observed treatment effect.
- All adverse events will be tabulated by their frequencies and proportions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort- Prospective, multi-center to collect population specific outcome measures in post-stroke patients
| Arm | Type | Receives |
|---|---|---|
| StimRouter Neuromodulation System | Experimental | Device: StimRouter Neuromodulation SystemAll eligible patients who are enrolled in this study will be treated with StimRouter stimulation therapy as part of standard of care for the entire duration of the study (6 months) and observed for post-market population-specific data. Standard recommended stimulation parameters for post-stroke shoulder pain include settings to elicit sensory response (paresthesia) as well as motor response (muscle contraction). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female age ≥18 years and confirmed diagnosis of stroke
- Competent to provide consent and comply with study requirements
- Minimum 3 months of severe chronic focal post-stroke shoulder pain
- Stable regimen of pain medications for >4 weeks prior to implant and willing to maintain equivalent dosage throughout the study
- A mean score of > 4 on the Brief Pain Inventory short form, question 3 (BPI-SF3)
Key exclusion criteria (18 listed)
- Patients who decline to provide written consent or to attend follow-up visits
- Shoulder pathology (e.g. rotator cuff tear, frozen shoulder etc) at target limb
- Evidence of a primary central or regional pain pattern inclusive of shoulder
- Diagnosed/confirmed shoulder dysfunction
- Botox or other neurolytic agent injections in last 3 months
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 Neuromodulation SystemAlso: StimRouterThe StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region. | Device | StimRouter Neuromodulation System |
Primary outcome
Brief Pain Inventory (BPI) Change
Time frame: Change from Baseline at Month 3
The Brief Pain Inventory (BPI) form is a standard pain assessment tool based on a 0 to 10 scale. The Average Pain at Rest (BPI question number 5) score will be assessed at Baseline and approximately 3 months after programming (therapy start) to determine if there is a significant reduction in average pain with the addition of StimRouter TM treatment to standard of care.
3 secondary outcomes
Patient Global Impression of Change (PGIC) Change
Time frame: Change from Baseline at Month 3
Patient Satisfaction
Time frame: Month 3
Standardized Shoulder Questionnaire (Shoulder Q) Change
Time frame: Change from Baseline at Month 3
Results and safety
The study was stopped early (reason given: Lack of subject participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Keith McBride study chair
Bioness Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StimRouter Neuromodulation System in people with Chronic Pain and Hemiplegic Shoulder Pain, run by Bioness Inc at 2 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 7 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: stopped early, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study was stopped early (reason given: Lack of subject participation). Results are not available in the source record.
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) Change (time frame: Change from Baseline at Month 3). 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 6 Jan 2021.