← Back to Search

Peripheral Nerve Stimulation

Peripheral Nerve Stimulation for Shoulder Impingement Syndrome

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

Worst pain in the last week>=4 (0-10 scale)

Shoulder pain of >3 months

Must not have

Uncontrolled bleeding disorder

Current osseus fracture in ipsilateral arm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior 7-days] ; baseline (week 1), end of treatment(week 5), 12 weeks post treatment, 24 weeks post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new pain relief method for those with shoulder pain caused by subacromial impingement syndrome.

Who is the study for?

This trial is for adults over 21 with chronic shoulder pain from subacromial impingement syndrome lasting more than 3 months, and a pain level of at least 4 out of 10. Participants must be able to care for their skin and manage dressing changes, with stable use of pain medication. Excluded are those with severe trauma to the shoulder, bleeding disorders, compromised immune systems, pregnancy, allergies to tape or adhesives, certain metal implants or conditions that prevent MRI scans.

What is being tested?

The study tests two types of peripheral nerve stimulation (PNS) against standard physical therapy in treating chronic shoulder pain due to SIS. One PNS type induces muscle contractions while the other does not. The effectiveness of these novel treatments will be compared to see which provides better relief from persistent shoulder discomfort.

What are the potential side effects?

Potential side effects may include skin irritation at the site where devices are attached or implanted for PNS treatment. There could also be temporary increased pain during initial treatment phases as muscles respond to stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My worst pain in the last week was 4 or more on a scale of 0 to 10.

Select...

I have had shoulder pain for more than 3 months.

Select...

I am 21 years old or older.

Exclusion Criteria

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

Select...

I have a bleeding disorder that is not under control.

Select...

I have a bone fracture in the same arm as my condition.

Select...

My immune system is weak due to a condition or medication.

Select...

I have a shoulder injury on the same side caused by a severe accident or assault.

Select...

I experience chronic pain in another part of my body almost daily.

Select...

I do not have a shoulder or skin infection, nor do I need antibiotics for any bacterial infection.

Select...

I have had surgery on the same side shoulder joint before.

Select...

I have severe shoulder pain and instability confirmed by a doctor.

Select...

I have had an amputation above the wrist on one side, not including just a single finger.

Select...

I have a nerve condition affecting my arm on the same side.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior 7-days] ; baseline (week 1), end of treatment(week 5), 12 weeks post treatment, 24 weeks post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior 7-days] ; baseline (week 1), end of treatment(week 5), 12 weeks post treatment, 24 weeks post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior 7-days] ; baseline (week 1), end of treatment(week 5), 12 weeks post treatment, 24 weeks post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in - Short Form (SF) question 3 (BPI-SF3)

Secondary study objectives

Change Mechanical Quantitative Sensory Testing (QST)

Change in Activities of Daily Living (ADL) performance -Shoulder Pain and Disability Index (SPADI)

Change in Activities of Daily Living(ADL( capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)

+2 more

Other study objectives

Occurrence of Adverse events

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Contraction Producing Peripheral Nerve StimulationExperimental Treatment2 Interventions

This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.

Group II: Non Contracting Producing Peripheral Nerve StimulationActive Control2 Interventions

This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contracting Producing Peripheral Nerve Stimulation

2019

N/A

~120

0 / 13Eligibility criteria met