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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in - Short Form (SF) question 3 (BPI-SF3)
Secondary outcome measures
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 moreOther outcome measures
Occurrence of Adverse events
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.
Find a Location
Who is running the clinical trial?
MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,347 Total Patients Enrolled
5 Trials studying Shoulder Pain
410 Patients Enrolled for Shoulder Pain
University of TexasOTHER
187 Previous Clinical Trials
142,385 Total Patients Enrolled
Richard D Wilson, MDPrincipal InvestigatorMetroHealth Medical Center
2 Previous Clinical Trials
155 Total Patients Enrolled
2 Trials studying Shoulder Pain
155 Patients Enrolled for Shoulder Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder that is not under control.I can check my skin and change dressings by myself or with help.I have a bone fracture in the same arm as my condition.My worst pain in the last week was 4 or more on a scale of 0 to 10.I am on a stable dose of pain medication, not exceeding one opioid or one non-opioid.You are allergic to tape or adhesive.I haven't had a steroid shot or pain treatment in my shoulder in the last 3 months.My immune system is weak due to a condition or medication.I have a shoulder injury on the same side caused by a severe accident or assault.I experience chronic pain in another part of my body almost daily.I do not have a shoulder or skin infection, nor do I need antibiotics for any bacterial infection.I have had shoulder pain for more than 3 months.I have had surgery on the same side shoulder joint before.You are currently receiving worker's compensation for a shoulder injury on the same side as the study.You currently have a device implanted in your body, like a pacemaker or deep brain stimulation system, that may interfere with the study device.I have severe shoulder pain and instability confirmed by a doctor.I have had an amputation above the wrist on one side, not including just a single finger.My doctor recommends surgery for my shoulder condition.I am 21 years old or older.I have a nerve condition affecting my arm on the same side.
Research Study Groups:
This trial has the following groups:- Group 1: Non Contracting Producing Peripheral Nerve Stimulation
- Group 2: Contraction Producing Peripheral Nerve Stimulation
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.
How many individuals is this research project accepting as participants?
"Affirmative. The clinical trial information available on clinicaltrials.gov reveals that this study, which was initially posted in March of 2019, is still actively recruiting participants. 116 patients need to be sourced from two different research sites."
Answered by AI
Are there any new opportunities to participate in this research?
"Absolutely. According to the information on clinicaltrials.gov, this medical trial is presently enrolling applicants and has been doing so since March 1st 2019 when it was initially posted. As of October 27th 2022, 116 patients are needed from two different sites for successful completion of the experiment."
Answered by AI
Does this research accept elderly participants?
"This study has an age range from 21 to 100; any individuals outside of this bracket are ineligible for participation."
Answered by AI
Who is able to submit applications for this research study?
"In this clinical trial, 116 people aged 21-100 are being enrolled who suffer from shoulder pain that has lasted for a minimum of 3 months. To be considered eligible, candidates must have reported 4 or higher on the 0-10 scale when asked to rate their worst pain in the past week and demonstrate either independent ability or support for managing skin care and dressing changes as well as stable analgesic intake (no more than one opioid/nonopioid)."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
MetroHealth Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve had shoulder pain since January or February of 2023. Have been going to physio therapy since that time, have been referred to a specialist, and have also received a steroid shot in my shoulder but have not seen any improvement. Through an mri, my Dr believes that this is shoulder impingement. I previously did not qualify for the study, but perhaps do now.
PatientReceived 2+ prior treatments
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