Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)

June 2, 2025 updated by: Richard Wilson, MD, MetroHealth Medical Center
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. This project will evaluate the efficacy of a novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The medical and socioeconomic impact of subacute and chronic shoulder pain is high, resulting in 12 million visits to physicians and over $7 billion in direct costs in the United States. The most common cause is subacromial impingement syndrome (SIS), which accounts for 30% of all shoulder pain. Approximately 35% of patients who present with subacromial impingement syndrome (SIS) are refractory to conservative management. For patients who have failed conservative management, there are no established treatments to reduce the pain. The long-term goal is to develop a therapeutic intervention to reduce pain related to subacromial impingement syndrome(SIS). A pilot trial of 3-week percutaneous peripheral nerve stimulation (PNS) for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS) that was refractory to conservative treatment that showed 60% of participants had successful treatment of pain that lasted at least 3 months. Thus, the primary objective of this 2 site randomized control trial (RCT) is to confirm the findings of this preliminary trial and determine the efficacy of peripheral nerve stimulation (PNS) for chronic subacromial impingement syndrome (SIS). The secondary objectives of this multisite randomized control trial (RCT) is to explore mechanisms of peripheral nerve stimulation (PNS) for the treatment of subacromial impingement syndrome (SIS), and to determine which characteristics can predict successful treatment with peripheral nerve stimulation (PNS). In order to accomplish these objectives, this trial is a multi-site, placebo controlled, double-blinded randomized control trial (RCT) to compare the efficacy of peripheral nerve stimulation (PNS) to sham peripheral nerve stimulation (PNS). Measures of pain, pain interference with activities of daily living (ADLs), capacity for activities of daily living (ADLs), Quality of life (QoL), and measures of central sensitization (pain thresholds, secondary hyperalgesia, and temporal summation) will be measured. Participants will be followed for a total of 24 weeks after treatment has concluded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • Univerity of Texas Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Shoulder pain of >3 months
  2. Age>=21
  3. Worst pain in the last week>=4 (0-10 scale)
  4. Ability to check skin and perform dressing changes, independently or with assistance
  5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic)

Exclusion Criteria:

  1. Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics
  2. Other chronic pain syndrome (Pain in another area of the body 15 or more days in the last 30 (more than half of the time) or taking daily analgesics for another pain syndrome)
  3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.)
  4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks
  5. Uncontrolled bleeding disorder
  6. Medical instability based on physician opinion after review of medical information
  7. Pregnancy
  8. Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.)
  9. Current Worker's compensation claim for the ipsilateral shoulder
  10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination
  11. Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile (e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by another person))
  12. Current osseus fracture in ipsilateral arm
  13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full)
  14. Surgical indication for shoulder treatment based on physician opinion
  15. Compromised immune system (immunodeficiency or immunosuppression)
  16. Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System
  17. Patients who have a tape or adhesive allergy
  18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc) - exclude from Magnetic resonance imaging (MRI) only

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Contraction Producing Peripheral Nerve Stimulation
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.
Device: Contracting Producing Peripheral Nerve Stimulation
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed.
Other Names:
  • Intramuscular Peripheral Nerve Stimulation
  • Intramuscular Electrical Nerve Stimulation
  • SMARTPATCH System
Other: Physical Therapy
All participants receive eight 1.0 hr. sessions of physical therapy (PT) over a 4-wk period from a therapist blinded to Peripheral Nerve Stimulation (PNS) treatment assignment. Each participant also performs home exercises. The primary objective of physical therapy (PT) and the home exercise program is to prevent re-injury by educating and training participants in the biomechanics and proper use of the shoulder and upper limb. During each in-lab session, participants are trained in the implementation of these exercises, which are individually adjusted and progressed with increasing external loads by using weights and elastic rubber bands.
Active Comparator: Non Contracting Producing Peripheral Nerve Stimulation
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.
Other: Physical Therapy
All participants receive eight 1.0 hr. sessions of physical therapy (PT) over a 4-wk period from a therapist blinded to Peripheral Nerve Stimulation (PNS) treatment assignment. Each participant also performs home exercises. The primary objective of physical therapy (PT) and the home exercise program is to prevent re-injury by educating and training participants in the biomechanics and proper use of the shoulder and upper limb. During each in-lab session, participants are trained in the implementation of these exercises, which are individually adjusted and progressed with increasing external loads by using weights and elastic rubber bands.
Device: Non Contracting Producing Peripheral Nerve Stimulation
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in - Short Form (SF) Question 3 (BPI-SF3)
Time Frame: Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment
The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the "pain worst" rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."
Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
Time Frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a laboratory based objective measure of ADL capacity. The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a timed test that provides a brief measure of functional ability of the upper limb while performing multi-level tasks that require grip/manipulation of the hand, elbow/shoulder reaching, sustained overhead work, and sustained positioning with an emphasis on assessing the limitations in functional capacity attributable to shoulder and neck disorders.The assessor measures the amount of time that the participant is able to perform each task using a stop watch. The task is completed 3 times- waist level, shoulder level, and eye level. Each task is continued for a maximum of 300 seconds or until a stopping criteria is reached. An overall summary score is calculated by averaging the time for the 3 tasks. Higher numbers indicate higher capacity (range 0-300 seconds).
Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The questions ask severity of pain based on an 0-10 numerical Rating Scale where 0 = no pain and 10 = the worst pain imaginable. In addition, it asks how much difficulty the participant has on a numerical rating scale where 0 = no difficulty and 10 = so difficult it requires help. Total disability score: _____/ 80 x 100 = %. Total SPADI score: _____ 130 x 100 = % Higher numbers indicate a higher level of disability (range 0-100%).
Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Change in Quality of Life - Short Form - 12(QoL - SF 12)
Time Frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Quality of life - Short form - 12 (QoL - SF 12) is a health related Quality of life (QoL) measure that assesses physical functioning, role limitation because of physical health problems, bodily pain, social functioning, general mental health, role. Scoring: Two summary scores are a mental component score (MCS-12) and a physical component score (PCS-12). The score ranges from 0 - 100 with higher scores indicating better health.
Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of Adverse events
Time Frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Related adverse events are documented as Safety data.
Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MetroHealth Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Texas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard D Wilson, MD, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB17-00643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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