StimRouter™ for Pain Management in Post-stroke Shoulder Pain (PSSP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03093935|
Recruitment Status : Not yet recruiting
First Posted : March 28, 2017
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Hemiplegic Shoulder Pain||Device: StimRouter Neuromodulation System||Not Applicable|
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)
- 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
1) 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cohort- Prospective, multi-center to collect population specific outcome measures in post-stroke patients|
|Masking:||None (Open Label)|
|Official Title:||StimRouter™ Neuromodulation System: Implanted Peripheral Nerve Stimulation for Pain Management When Treating Patients With Chronic Post-stroke Shoulder-pain|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||June 15, 2019|
|Estimated Study Completion Date :||September 20, 2019|
Experimental: StimRouter Neuromodulation System
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).
Device: StimRouter Neuromodulation System
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.
Other Name: StimRouter
- 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.
- Patient Global Impression of Change (PGIC) Change [ Time Frame: Change from Baseline at Month 3 ]Patient Global Impression of Change (PGIC) survey assesses perceived overall change in a combination of pain and life quality
- Patient Satisfaction [ Time Frame: Month 3 ]Patient Satisfaction will be measured by a numeric (i.e., 1-5) rating scale (NRS)
- Standardized Shoulder Questionnaire (Shoulder Q) Change [ Time Frame: Change from Baseline at Month 3 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093935
|Contact: Keith McBride||(661) firstname.lastname@example.org|
|Contact: Charlene Myersemail@example.com|
|United States, Florida|
|Brooks Rehabilitation Hospital||Recruiting|
|Jacksonville, Florida, United States, 32216|
|Contact: Raine Osborne 904-345-7373 Raine.Osborne@Brooksrehab.org|
|Principal Investigator: Kenneth Ngo, MD|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84123|
|Contact: Heidi Hansen 801-585-2373 Heidi.firstname.lastname@example.org|
|Contact: Mary Pautler 801.585.2373 email@example.com|
|Principal Investigator: Heather Hayes, NCS, PhD|
|Study Chair:||Keith McBride||Bioness Inc|