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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

Must not have

History of Parkinson's disease, spinal cord injury (SCI), traumatic brain injury (TBI), multiple sclerosis (MS), or ipsilateral upper extremity (UE) lower motor neuron lesion

Need to take > 1 opioid and > 1 nonopioid analgesic medication for HSP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2 - week 5

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have weakness in my shoulder muscles.

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I have had hot flashes for more than 3 months.

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I am at least 21 years old but younger than 90.

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I have shoulder pain in specific areas, especially when moving or touching it.

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I experience moderate to severe pain from my condition.

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I can think and communicate well enough to follow study instructions.

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My shoulder pain started or got worse after my last stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of Parkinson's, SCI, TBI, MS, or a specific nerve injury in my arm.

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I take more than one opioid and non-opioid pain medication for HSP.

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I have had more than one seizure a month for the last six months.

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I have had heart rhythm problems that affected my blood pressure.

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I have had skin infections near my joints or recurring skin infections.

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I have significant difficulty communicating.

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I have a history of heart valve problems.

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I do not have a bleeding disorder and my INR is below 3.0.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 - week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 - week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 - week 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Pain Inventory (BPI)- Short Form (SF) question 3 (BPI-SF3)

Other study objectives

Adverse Events (Related)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1520

0 / 15Eligibility criteria met