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

NCT ID: NCT03752619

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2024-06-21

Brief Summary

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).

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.

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Tendinitis; Shoulder Bursitis; Pain, Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Contracting Producing Peripheral Nerve Stimulation

Intervention Type: DEVICE

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.

Physical Therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Non Contracting Producing Peripheral Nerve Stimulation

Intervention Type: DEVICE

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.

Physical Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Intramuscular Peripheral Nerve Stimulation; Intramuscular Electrical Nerve Stimulation; SMARTPATCH System

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard Wilson, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard D Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

MetroHealth Medical Center

Cleveland, Ohio, United States

Univerity of Texas Southwestern

Dallas, Texas, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 9924205 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20584793 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 9160946 (View on PubMed)

Pierson C, Wilson R, Brewer-Mixon K, Tzen YT, Williamson J, Hansen K, Hisel T, Jain N. Pressure pain sensitivity is independent of structural pathology in patients with subacromial pain syndrome: a cross-sectional analysis. Pain Med. 2025 Apr 1;26(4):173-179. doi: 10.1093/pm/pnae123.

Reference Type: DERIVED

PMID: 39589920 (View on PubMed)

Cleland T, Jain NB, Chae J, Hansen KM, Hisel TZ, Gunzler DD, Whitehair VC, Kim CH, Wilson RD. The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain. Trials. 2020 Mar 6;21(1):248. doi: 10.1186/s13063-020-4174-x.

Reference Type: DERIVED

PMID: 32143732 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://fescenter.org/index.php

Functional Electrical Stimulation (FES)Center

http://www.metrohealth.org

Metrohealth clinic trials

Other Identifiers

IRB17-00643

Identifier Type: -

Identifier Source: org_study_id