Shoulder Pain ChronicPhase 2BBPMNCT00567541
An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects
A Phase 2 study testing Battery Powered Microneuromodulator (BBPM) in people with Shoulder Pain Chronic, run by Bioness Inc at 3 sites in United States.
Trial summary
The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shoulder Pain Chronic
- What is being tested?
- Battery Powered Microneuromodulator (BBPM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2007to Dec 2012
- Phase
- Phase 2
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Chronic post-stroke duration greater than or equal to 6 months
- Unilateral hemiplegic shoulder pain persisting for ≥6 months
- Hemiparesis (shoulder abduction graded <5/5 on Manual Muscle Testing ipsilateral to the shoulder in which the subject has chronic pain
- Shoulder pain ≥ 6/10 (on 0-10 numeric rating scale (NRS) for worst pain in last week (BPI #12))
- Ability to give informed consent and understand study requirements
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- Ability to quantify pain using a 0-10 numeric rating scale. (A screening tool will be used to ensure that participants can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other.)
- Willing and able to understand and comply with all study-related procedures during the course of the study
- Motivated to maintain an accurate diary for the study duration
Who cannot join
- Hemineglect (i.e., extinguish to double simultaneous stimulation)
- Shoulder trauma or diagnosed shoulder pathology prior to stroke; history of any shoulder surgery, regardless of whether procedure preceded for followed stroke.
- Need to take >1 pain medication (opioid or non-opioid) for shoulder pain
- Regular use of pain medication for chronic pain other than shoulder pain
- Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder
- Unable, per their prescribing physician, to stop antiplatelet medications (e.g., aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat), and eptifibatide (Integrilin)) for at least 7 days prior to device implantation.
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- Cardiac pacemaker
- Implanted neurostimulator (e.g., spinal cord, deep brain, vagus nerve) or implanted pump or infusion device
- Prosthetic heart valve or valvular heart disease requiring antibiotic prophylaxis
- History of cardiac arrhythmia with hemodynamic instability
- Uncontrolled seizures (> 1 seizure per month)
- Pregnant or plan on becoming pregnant during the study period
- Medical instability
- Currently require, or likely to require, diathermy
- Currently require, or anticipated to require, MRI within 8 weeks of projected device implantation date
- History of adverse reactions to local anesthetic (e.g., lidocaine)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Center for Pain Relief
Charleston, West Virginia, 25301
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Feasibility Study of the Bioness Battery-Powered Microneuromodulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects
The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.
Read the detailed description
This is a prospective, multi-center, randomized, controlled, double-blinded parallel study designed to evaluate feasibility and safety. The primary purpose of this study is to demonstrate the clinical feasibility of implanting the BBPM near a peripheral nerve for the treatment of chronic, intractable, pain in this case represented by chronic regional shoulder pain in hemiplegic stroke patients. This is a 48-week efficacy study with safety data collection throughout the study period and up to 2 years for all available subjects. Each study arm will receive therapeutic level stimulation for a total of 12 consecutive weeks (Weeks 1-12 for Active treatment group and Weeks 24-36 for the sham group) during the 48 weeks.
- Conditions
- Shoulder Pain Chronic
- Being tested
- Battery Powered Microneuromodulator (BBPM)
- Keywords
- shoulder, pain, stroke, subluxation
- Medical subject headings
- Pain, Stroke, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battery Powered Microneuromodulator (BBPM)Device
Also called Bioness Battery Powered Microneuromodulator
The Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo).
| Study group | Role | What they receive |
|---|---|---|
| Active BBPM stimulation | Active comparator | Therapeutic Stimulation is applied via the Battery Powered Microneuromodulator (BBPM) which is programmed to deliver set stimulation parameters with approximate frequency of 30 Hz, current 5mA for 200 microseconds for the first 12 weeks of the study. The BBPM is implanted near the axillary nerve within the quadrilateral space. Receives: Device: Battery Powered Microneuromodulator (BBPM) |
| Sham BBPM stimulation | Placebo comparator | The Battery Powered Microneuromodulator is implanted near the axillary nerve within the quadrilateral space. The BBPM is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation over a 12 week period. Receives: Device: Battery Powered Microneuromodulator (BBPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of Chronic Shoulder Pain
Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.
Measured: From baseline to 48 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2011
- Study completionDec 2012
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 Shoulder Pain ChronicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioness Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Friedman, MD, Principal investigator, Virginia Mason Seattle Main ClinicTim Deer, MD, Principal investigator, The Center for Pain ReliefZiyad Ayyoub, M.D., Principal investigator, Rancho Los Amigos National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567541
- Sponsor's protocol ID
- CP-BBPM-001
- Acronym
- BBPM
- Status last verified
- Mar 2016
- First submitted
- 3 Dec 2007
- Last updated
- 1 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Bioness Battery-Powered Microneuromodulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects
- ClinicalTrials.gov ID
- NCT00567541
- Acronym / sponsor ID
- BBPM / CP-BBPM-001
- Conditions
- Shoulder Pain Chronic
- Keywords
- shoulder, pain, stroke, subluxation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bioness IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Posted 1 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.
Detailed description
This is a prospective, multi-center, randomized, controlled, double-blinded parallel study designed to evaluate feasibility and safety. The primary purpose of this study is to demonstrate the clinical feasibility of implanting the BBPM near a peripheral nerve for the treatment of chronic, intractable, pain in this case represented by chronic regional shoulder pain in hemiplegic stroke patients. This is a 48-week efficacy study with safety data collection throughout the study period and up to 2 years for all available subjects. Each study arm will receive therapeutic level stimulation for a total of 12 consecutive weeks (Weeks 1-12 for Active treatment group and Weeks 24-36 for the sham group) during the 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active BBPM stimulation | Active comparator | Device: Battery Powered Microneuromodulator (BBPM)Therapeutic Stimulation is applied via the Battery Powered Microneuromodulator (BBPM) which is programmed to deliver set stimulation parameters with approximate frequency of 30 Hz, current 5mA for 200 microseconds for the first 12 weeks of the study. The BBPM is implanted near the axillary nerve within the quadrilateral space. |
| Sham BBPM stimulation | Placebo comparator | Device: Battery Powered Microneuromodulator (BBPM)The Battery Powered Microneuromodulator is implanted near the axillary nerve within the quadrilateral space. The BBPM is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation over a 12 week period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Chronic post-stroke duration greater than or equal to 6 months
- Unilateral hemiplegic shoulder pain persisting for ≥6 months
- Hemiparesis (shoulder abduction graded <5/5 on Manual Muscle Testing ipsilateral to the shoulder in which the subject has chronic pain
- Shoulder pain ≥ 6/10 (on 0-10 numeric rating scale (NRS) for worst pain in last week (BPI #12))
Key exclusion criteria (16 listed)
- Hemineglect (i.e., extinguish to double simultaneous stimulation)
- Shoulder trauma or diagnosed shoulder pathology prior to stroke; history of any shoulder surgery, regardless of whether procedure preceded for followed stroke.
- Need to take >1 pain medication (opioid or non-opioid) for shoulder pain
- Regular use of pain medication for chronic pain other than shoulder pain
- Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder
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 |
|---|---|---|
| Battery Powered Microneuromodulator (BBPM)Also: Bioness Battery Powered MicroneuromodulatorThe Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo). | Device | Active BBPM stimulation, Sham BBPM stimulation |
Primary outcome
Relief of Chronic Shoulder Pain
Time frame: From baseline to 48 week follow up
Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrew Friedman, MD principal investigator
Virginia Mason Seattle Main Clinic
Tim Deer, MD principal investigator
The Center for Pain Relief
Ziyad Ayyoub, M.D. principal investigator
Rancho Los Amigos National Rehabilitation Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Battery Powered Microneuromodulator (BBPM) in people with Shoulder Pain Chronic, run by Bioness Inc at 3 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 9 inclusion and 16 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 1 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 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 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?
Relief of Chronic Shoulder Pain (time frame: From baseline to 48 week 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 1 Apr 2016.