Peripheral Nerve Stimulation for Shoulder Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
MetroHealth Medical Center, Cleveland, OH
Shoulder Pain+1 More
Peripheral Nerve Stimulation - Device
Eligibility
18+
All Sexes
Eligible conditions
Shoulder Pain

Study Summary

Multimodal Treatment for Hemiplegic Shoulder Pain

See full description

Eligible Conditions

  • Shoulder Pain
  • Stroke

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Peripheral Nerve Stimulation will improve 1 primary outcome and 1 other outcome in patients with Shoulder Pain. Measurement will happen over the course of Prior 7-days.

Prior 7-days
Brief Pain Inventory (BPI)- Short Form (SF) question 3 (BPI-SF3)
Week 5
Adverse Events (Related)

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

sham-PNS + PT
PNS + PT

This trial requires 132 total participants across 3 different treatment groups

This trial involves 3 different treatments. Peripheral Nerve Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PNS + PTThe 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.
sham-PNS + PTThe 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.
PNS + sham-PTThe 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
N/A
~1350

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 2 - week 5
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 2 - week 5 for reporting.

Who is running the study

Principal Investigator
R. W.
Prof. Richard Wilson, MD
MetroHealth Medical Center

Closest Location

MetroHealth Medical Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
weakness of shoulder abductors (≤4/5 on Medical Research Council (MRC) scale if isolated movement is present);
≥ 21-yrs old; < 90-yrs old;
shoulder pain localized to the glenohumeral joint, subacromial area or deltoid insertion associated with: a) rest; b) passive abduction or external rotation range of motion (ROM); c) active abduction ROM; or, d) manual palpation;
shoulder pain onset or worsening after the most recent stroke;
time of stroke ≥ 3-mo;
duration of HSP ≥3-mo;
HSP with moderate to severe pain (BPI SF-3 ≥ 4);
cognitive and communication ability to fulfill study requirements (cognitive ability based upon a score of ≥24 on the Mini Mental Status Exam (MMSE));
availability of reliable adult who can assist with study procedures if necessary;
willing and able to report shoulder pain and other conditions and complete study visits throughout the 4 month study period.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is shoulder pain?

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There is a lack of agreement on what shoulder pain really is and what should be regarded as an actual disease issue. As the definition of pain remains a topic of debate, the interpretation of results from pain studies will also be problematic.

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What are the signs of shoulder pain?

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The presentation of shoulder pain to the GP is most probably pain. Other signs are typically vague or atypical. A GP should be aware of these signs and consider ordering a full shoulder examination.

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How many people get shoulder pain a year in the United States?

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Around 13 million people in the United States have shoulder pain each year. This rate is higher in the age group 60 to 64 years, where around 45% have shoulder pain at least once a year. Half of persons without shoulder pain have shoulder pain at least once a month. Findings from a recent study demonstrates high rates of shoulder pain and symptoms in the United States.

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What are common treatments for shoulder pain?

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Common treatments for shoulder pain include pain medication (acetaminophen, NSAIDs, and acetaminophen), shoulder exercises, and physical therapy. Most patients have had more than one intervention with varying duration of effect. There appears to be no significant difference in the effect of treatment of shoulder pain of different shoulder symptoms.

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What causes shoulder pain?

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This is the first longitudinal study of shoulder pain, and the first to use a self-made interview instrument in this area. We demonstrated that the most common complaint is tenderness to the touch, and that shoulder pain is highly prevalent. We also showed that symptoms associated with shoulder pain include pain, joint stiffness and sleep-related shoulder complaints. The study demonstrated that the assessment of symptomatology is important to make informed decisions regarding the appropriate use of healthcare services, the need for physiotherapy, and for the development and provision of appropriate strategies to relieve shoulder pain.

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Can shoulder pain be cured?

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In this series our rehabilitation program and [pain management](https://www.withpower.com/clinical-trials/pain-management) proved to be most successful in resolving symptoms in patients with non-specific shoulder pain. A multidisciplinary rehabilitation program including occupational and physical therapists as well as athletic trainers, has a high patient acceptance and may be beneficial in the long term, irrespective of treatment, in the pain relief of patients with shoulder pain and shoulder musculoskeletal disorders, such as rotator cuff tears, tendinitis, and impingement, amongst others, particularly in young patients. In future studies, longer follow-up periods are needed to examine this issue.

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Is peripheral nerve stimulation safe for people?

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As peripheral nerve stimulation is a new and evolving treatment it is essential for people’s safety that those involved in administering and interpreting the procedure are well trained to safely handle stimulator circuitry and stimulate nerves using the correct current, pulse duration and frequency, and that they are appropriately supported in case emergencies.

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How does peripheral nerve stimulation work?

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Results from a recent paper of this study are promising regarding the treatment of various types of neuropathic pain through the stimulation of nerve fibers.

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Does peripheral nerve stimulation improve quality of life for those with shoulder pain?

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Peripheral nerve stimulation can improve the quality of life for patients with shoulder pain. Patients with a reduced disability and a high degree of pain self-control may benefit most from this treatment.

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What does peripheral nerve stimulation usually treat?

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PNS is a valuable treatment option for chronic muscle pain. It has also found promise in treating pain in a range of non-musculoskeletal pain conditions. PNS, in the form of a transcutaneous electric nerve stimulation (TENS) device, appears to be an effective treatment in a variety of non-pain conditions, including postherpetic neuralgia, diabetic neuropathic pain and shoulder pain.

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What is the average age someone gets shoulder pain?

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A study was conducted using a sample of students from a university in Pakistan to investigate the factors that cause shoulder pain. In a recent study, findings found out that there are gender, age, income, and sports as the most important factors that cause shoulder pain among Pakistani students in this study. Also, in this study, the most common age people get shoulder pain was between 17-27 yrs old, while the second most prevalent age age was at 10-21 yrs old.

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What are the latest developments in peripheral nerve stimulation for therapeutic use?

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Continuous application of PNS is still an investigational tool in clinical settings. PNS may offer a versatile treatment modality, even for indications such as pain, fatigue, and neuropathic pain, as such applications were described well in these clinical settings. An interesting development for PNS is the use of high-frequency stimulation, which is now being investigated for the purpose of analgesia.

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