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

NCT03752619 | Completed Results DMC FDA Device

• 1 other identifier: IRB17-00643
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Keywords

peripheral nerve stimulation; Sprint; stimulation

Outcome Measures

Primary Outcomes (1)

• Change in - Short Form (SF) Question 3 (BPI-SF3)

  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 Outcomes (3)

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

  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)

  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)

  Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment

Study Arms (2)

Contraction Producing Peripheral Nerve Stimulation

EXPERIMENTAL

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; Other: Physical Therapy

Non Contracting Producing Peripheral Nerve Stimulation

ACTIVE COMPARATOR

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.

Device: Non Contracting Producing Peripheral Nerve Stimulation; Other: Physical Therapy

Interventions

Contracting Producing Peripheral Nerve Stimulation 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.

Also known as: Intramuscular Peripheral Nerve Stimulation, Intramuscular Electrical Nerve Stimulation, SMARTPATCH System

Contraction Producing Peripheral Nerve Stimulation

Non Contracting Producing Peripheral Nerve Stimulation 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.

Non Contracting Producing Peripheral Nerve Stimulation

Physical Therapy 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.

Contraction Producing Peripheral Nerve Stimulation; Non Contracting Producing Peripheral Nerve Stimulation

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics
• 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)
• Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.)
• Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks
• Uncontrolled bleeding disorder
• Medical instability based on physician opinion after review of medical information
• Pregnancy
• Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.)
• Current Worker's compensation claim for the ipsilateral shoulder
• Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination
• 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))
• Current osseus fracture in ipsilateral arm
• Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full)
• Surgical indication for shoulder treatment based on physician opinion
• Compromised immune system (immunodeficiency or immunosuppression)

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• University of Texas: collaborator

Study Sites (2)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Univerity of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (12)

• Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.

  PMID: 9924205 BACKGROUND

• Johnson MP, Crossley KL, O'neil ME, Al-Zakwani IS. Estimates of Direct Health Care Expenditures Among Individuals With Shoulder Dysfunction in the United States J Ortho Sports Phys Ther 2005;35(1,A4).

  BACKGROUND

• Cadogan A, Laslett M, Hing WA, McNair PJ, Coates MH. A prospective study of shoulder pain in primary care: prevalence of imaged pathology and response to guided diagnostic blocks. BMC Musculoskelet Disord. 2011 May 28;12:119. doi: 10.1186/1471-2474-12-119.

  PMID: 21619663 BACKGROUND

• van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.

  PMID: 8546527 BACKGROUND

• Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.

  PMID: 15808040 BACKGROUND

• Crawshaw DP, Helliwell PS, Hensor EM, Hay EM, Aldous SJ, Conaghan PG. Exercise therapy after corticosteroid injection for moderate to severe shoulder pain: large pragmatic randomised trial. BMJ. 2010 Jun 28;340:c3037. doi: 10.1136/bmj.c3037.

  PMID: 20584793 BACKGROUND

• Cummins CA, Sasso LM, Nicholson D. Impingement syndrome: temporal outcomes of nonoperative treatment. J Shoulder Elbow Surg. 2009 Mar-Apr;18(2):172-7. doi: 10.1016/j.jse.2008.09.005. Epub 2008 Dec 18.

  PMID: 19095464 BACKGROUND

• Johansson K, Oberg B, Adolfsson L, Foldevi M. A combination of systematic review and clinicians' beliefs in interventions for subacromial pain. Br J Gen Pract. 2002 Feb;52(475):145-52.

  PMID: 11885825 BACKGROUND

• Litaker D, Pioro M, El Bilbeisi H, Brems J. Returning to the bedside: using the history and physical examination to identify rotator cuff tears. J Am Geriatr Soc. 2000 Dec;48(12):1633-7. doi: 10.1111/j.1532-5415.2000.tb03875.x.

  PMID: 11129754 BACKGROUND

• Morrison DS, Frogameni AD, Woodworth P. Non-operative treatment of subacromial impingement syndrome. J Bone Joint Surg Am. 1997 May;79(5):732-7. doi: 10.2106/00004623-199705000-00013.

  PMID: 9160946 BACKGROUND

• 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.

  PMID: 39589920 DERIVED

• 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.

  PMID: 32143732 DERIVED

Related Links

• Functional Electrical Stimulation (FES)Center
• Metrohealth clinic trials

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Results Point of Contact

• Title: Dr. Richard Wilson
• Organization: MetroHealth Medical Center

rwilson@metrohealth.org

216-957-3623

Study Officials

• Richard D Wilson, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 26, 2018
• Study Start: March 1, 2019
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: June 17, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-06

Locations

US (2)