Post-stroke Shoulder PainNCT01847885
Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System
A study testing Smartpatch Peripheral Nerve Stimulation (PNS) System in people with Post-stroke Shoulder Pain and Hemiplegic Shoulder Pain, run by SPR Therapeutics, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Post-stroke Shoulder Pain, Hemiplegic Shoulder Pain
- What is being tested?
- Smartpatch Peripheral Nerve Stimulation (PNS) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2013to 14 Nov 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years of age
- Post-stroke shoulder pain
- At least 6 months after stroke that caused shoulder pain
Who cannot join
- Use of habit-forming (narcotic) medications
- Bleeding disorder
- History of recurrent skin infections
- Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or Complex Regional Pain Syndrome
- Heart arrhythmia or artificial heart valves
- Uncontrolled seizures
- Implanted Electronic Device
- Pregnant
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolinas Rehabilitation/Carolinas Healthcare
Charlotte, North Carolina, 28203
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Weill Cornell Medical Center
New York, New York, 10065
Kessler Foundation Research Center
West Orange, New Jersey, 07052
About this study
Official title: A Randomized, Double-Blinded, Placebo-Control Multicenter Pivotal Study of the Smartpatch Peripheral Nerve Stimulation (PNS) System for the Treatment of Chronic Post-Stroke Shoulder Pain
The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).
- Being tested
- Smartpatch Peripheral Nerve Stimulation (PNS) System
- Keywords
- electrical stimulation, neurostimulation, neuromodulation, post-stroke shoulder pain, hemiplegic shoulder pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartpatch Peripheral Nerve Stimulation (PNS) SystemDevice
Also called Smartpatch System, Smartpatch
The Smartpatch System is an Investigation Device which delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).
| Study group | Role | What they receive |
|---|---|---|
| Smartpatch Treatment Group | Experimental | Subjects in the Treatment Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation. Receives: Device: Smartpatch Peripheral Nerve Stimulation (PNS) System |
| Smartpatch Control Group | Sham comparator | Subjects in the Control Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, but will not receive any electrical stimulation. Receives: Device: Smartpatch Peripheral Nerve Stimulation (PNS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)
A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.
Measured: Baseline, End of Treatment (4-weeks of Treatment/Control)
Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
Measured: 16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment
Secondary outcomes (7)
Change From Baseline Shoulder Pain Interference at End of Treatment
The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week. The mean of these seven scores will be calculated to obtain the pain interference score.
Measured: Baseline, End of Treatment (4-weeks of Treatment/Control)
Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment
A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at 12 weeks post-treatment was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for 12 weeks post-treatment was compared to the group mean of the median scores for the control group at baseline.
Measured: Baseline, 12-wks post-treatment
Change From Baseline Quality of Life at End of Treatment
The Medical Outcomes Study Short Form (SF-36v2) was administered at clinic visits to assess the impact of peripheral nerve stimulation on the subject's health-related quality of life. The SF-36v2 is a generic health survey designed to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The 36 questions were grouped into two components: physical and mental. The survey was scored using norm-based scoring algorithm where a score of 0 indicates maximum disability and a score of 100 indicates no disability. Change in each component score was derived from End of Treatment score minus baseline score.
Measured: Baseline, End of Treatment (4-weeks of Treatment/Control)
Change From Baseline Average Pain Intensity at End of Treatment
A diary was used in the study to capture daily average shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5) and is stated as "please rate your pain by circling the one number that best describes your pain on the average". BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The mean scores were calculated for each diary period. The mean diary score at End of Treatment (EOT) was compared to the mean baseline diary score to calculate the change in pain intensity.
Measured: Baseline, End of Treatment (4-weeks of Treatment/Control)
Patient Global Impression of Change at End of Treatment
The Patient Global Impression of Change (PGIC) scale was administered at EOT to assess subject perception of overall improvement and patient preferences. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline.
Measured: End of Treatment (4-weeks of Treatment/Control)
Change in Pain Medication Usage at End of Treatment
Subjects completed 7-day diaries, in which they listed all pain medications they took during the 7 days. A blinded third party medication committee reviewed medications collected for each 7-day diary period and scored medication changes, in comparison to the baseline diary medications as "no change" (no change in dosage or change is not clinically meaningful to impact pain outcomes), "increase" (clinically meaningful increase in medication that would impact pain outcomes), or "decrease" (clinically meaningful decrease in medication that would impact pain outcomes).
Measured: End of Treatment (4-weeks of Treatment/Control)
Clinical Global Impression of Improvement at End of Treatment
The Blinded Evaluator rated each subject enrolled at their site using a question adapted from the Clinical Global Impression (CGI) scale, known as the Clinical Global Impression-Improvement scale (CGI-I). For the CGI-I, a Blinded Evaluator was asked to rate the subject's total improvement compared to their condition at baseline. The CGI-I uses a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved".
Measured: End of Treatment (4-weeks of Treatment/Control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startApr 2013
- Primary completion21 Aug 2015
- Study completion14 Nov 2016
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 Post-stroke Shoulder 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPR Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847885
- Sponsor's protocol ID
- 0131-CSP-000
- Status last verified
- Oct 2017
- First submitted
- 23 Apr 2013
- Last updated
- 16 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Control Multicenter Pivotal Study of the Smartpatch Peripheral Nerve Stimulation (PNS) System for the Treatment of Chronic Post-Stroke Shoulder Pain
- ClinicalTrials.gov ID
- NCT01847885
- Acronym / sponsor ID
- 0131-CSP-000
- Keywords
- electrical stimulation, neurostimulation, neuromodulation, post-stroke shoulder pain, hemiplegic shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- SPR Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- 21 Aug 2015 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Posted 16 Oct 2017
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 determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartpatch Treatment Group | Experimental | Device: Smartpatch Peripheral Nerve Stimulation (PNS) SystemSubjects in the Treatment Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation. |
| Smartpatch Control Group | Sham comparator | Device: Smartpatch Peripheral Nerve Stimulation (PNS) SystemSubjects in the Control Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, but will not receive any electrical stimulation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 21 years of age
- Post-stroke shoulder pain
- At least 6 months after stroke that caused shoulder pain
Key exclusion criteria (8 listed)
- Use of habit-forming (narcotic) medications
- Bleeding disorder
- History of recurrent skin infections
- Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or Complex Regional Pain Syndrome
- Heart arrhythmia or artificial heart valves
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 |
|---|---|---|
| Smartpatch Peripheral Nerve Stimulation (PNS) SystemAlso: Smartpatch System, SmartpatchThe Smartpatch System is an Investigation Device which delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator). | Device | Smartpatch Control Group, Smartpatch Treatment Group |
Primary outcome
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)
Time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)
A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.
Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups
Time frame: 16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
7 secondary outcomes
Change From Baseline Shoulder Pain Interference at End of Treatment
Time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)
Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment
Time frame: Baseline, 12-wks post-treatment
Change From Baseline Quality of Life at End of Treatment
Time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)
Change From Baseline Average Pain Intensity at End of Treatment
Time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)
Patient Global Impression of Change at End of Treatment
Time frame: End of Treatment (4-weeks of Treatment/Control)
Change in Pain Medication Usage at End of Treatment
Time frame: End of Treatment (4-weeks of Treatment/Control)
Clinical Global Impression of Improvement at End of Treatment
Time frame: End of Treatment (4-weeks of Treatment/Control)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartpatch Peripheral Nerve Stimulation (PNS) System in people with Post-stroke Shoulder Pain and Hemiplegic Shoulder Pain, run by SPR Therapeutics, Inc. at 5 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 3 inclusion and 8 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 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 16 Oct 2017). 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?
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) (time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)). The study lists 2 primary outcomes in all. 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 16 Oct 2017.