Your session is about to expire
← Back to Search
Device
Multimodal Treatment for Post-Stroke Shoulder Pain
N/A
Waitlist Available
Led By Richard D Wilson, MD
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weakness of shoulder abductors (≤4/5 on Medical Research Council (MRC) scale if isolated movement is present)
Duration of HSP ≥3-mo
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 - week 5
Awards & highlights
Study Summary
This trial is looking at a new treatment for shoulder pain after a stroke, which is called intramuscular peripheral nerve stimulation (PNS). They are comparing it to physical therapy (PT), which is the most commonly prescribed treatment for this type of pain.
Who is the study for?
This trial is for adults aged 21-90 with shoulder pain after a recent stroke, who can communicate and participate in the study for 4 months. They should have moderate to severe pain and weakness in shoulder muscles but not be on multiple pain medications or have certain medical conditions like skin infections, uncontrolled seizures, heart issues, or bleeding disorders.Check my eligibility
What is being tested?
The trial tests if peripheral nerve stimulation (PNS), physical therapy (PT), or their combination is best for long-term relief of hemiplegic shoulder pain post-stroke. PNS involves stimulating shoulder nerves with an electrode while PT focuses on biomechanics correction.See study design
What are the potential side effects?
Potential side effects may include discomfort at the electrode insertion site for PNS, muscle soreness from PT exercises, and possible skin irritation from adhesives used during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have weakness in my shoulder muscles.
Select...
I have had hot flashes for more than 3 months.
Select...
I am at least 21 years old but younger than 90.
Select...
I have shoulder pain in specific areas, especially when moving or touching it.
Select...
I experience moderate to severe pain from my condition.
Select...
I can think and communicate well enough to follow study instructions.
Select...
My shoulder pain started or got worse after my last stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2 - week 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2 - week 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Pain Inventory (BPI)- Short Form (SF) question 3 (BPI-SF3)
Other outcome measures
Adverse Events (Related)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: PNS + PTExperimental Treatment2 Interventions
The PNS+PT Group will receive peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Group II: sham-PNS + PTActive Control2 Interventions
The sham-PNS + PT Group will receive sham peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Group III: PNS + sham-PTActive Control2 Interventions
The PNS + sham-PT Group will receive peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of sham outpatient physical therapy not focused on shoulder pain over the same four week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral Nerve Stimulation
2016
Completed Phase 1
~1380
Find a Location
Who is running the clinical trial?
Shirley Ryan AbilityLabOTHER
192 Previous Clinical Trials
14,753 Total Patients Enrolled
69 Trials studying Stroke
6,213 Patients Enrolled for Stroke
MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,257 Total Patients Enrolled
16 Trials studying Stroke
827 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,609 Total Patients Enrolled
79 Trials studying Stroke
5,255 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have weakness in my shoulder muscles.I regularly take pain medication for another chronic condition.I have a history of Parkinson's, SCI, TBI, MS, or a specific nerve injury in my arm.You have numb skin.I take more than one opioid and non-opioid pain medication for HSP.I have had hot flashes for more than 3 months.I am at least 21 years old but younger than 90.I have had more than one seizure a month for the last six months.I have had heart rhythm problems that affected my blood pressure.I have shoulder pain in specific areas, especially when moving or touching it.I experience moderate to severe pain from my condition.I can think and communicate well enough to follow study instructions.You have had an allergic reaction to lidocaine in the past.I have a history of complex pain conditions as determined by my doctor.I can report my shoulder pain and attend all study visits for 4 months.I have not had Botox or steroid injections in my shoulder in the last 3 months.I have had skin infections near my joints or recurring skin infections.You have a heart pacemaker or another implanted electronic device.My shoulder pain started or got worse after my last stroke.You are sensitive to the materials used for skin electrodes and medical adhesives.I have significant difficulty communicating.My stroke happened more than 3 months ago.I have a history of heart valve problems.I do not have a bleeding disorder and my INR is below 3.0.I am getting OT or PT for my hereditary spastic paraplegia.
Research Study Groups:
This trial has the following groups:- Group 1: sham-PNS + PT
- Group 2: PNS + PT
- Group 3: PNS + sham-PT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Share this study with friends
Copy Link
Messenger