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

Primary Purpose

Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Tendinitis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Contracting Producing Peripheral Nerve Stimulation

Non Contracting Producing Peripheral Nerve Stimulation

Physical Therapy

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring peripheral nerve stimulation, Sprint, stimulation

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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)
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
Patients who have a tape or adhesive allergy
Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc) - exclude from Magnetic resonance imaging (MRI) only

Sites / Locations

MetroHealth Medical CenterRecruiting
Univerity of Texas SouthwesternRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Contraction Producing Peripheral Nerve Stimulation

Non Contracting Producing Peripheral Nerve Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Change in Brief Pain Inventory (BPI)- Short Form (SF)

The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The question asks participants to rate their 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." ." In addition, the question asks the participant to rate how their pain interferes with daily activities where "0" indicates "does not interfere and "10" indicates "completely interferes".

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

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

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

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 pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.The question asks 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 = % Minimum Detectable Change (90% confidence) = 13 points (Change less than this may be attributable to measurement error). lower score is better.

Change in Quality of life - Short form - 12(QoL - SF 12)

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 scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. Lower score is better.

Change Mechanical Quantitative Sensory Testing (QST)

used to evaluate central sensitization

Full Information

NCT ID

NCT03752619

First Posted

November 20, 2018

Last Updated

January 20, 2023

Sponsor

MetroHealth Medical Center

Collaborators

University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT03752619

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MetroHealth Medical Center

Collaborators

University of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

peripheral nerve stimulation, Sprint, stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Contraction Producing Peripheral Nerve Stimulation

Arm Type

Experimental

Arm Description

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.

Arm Title

Non Contracting Producing Peripheral Nerve Stimulation

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Contracting Producing Peripheral Nerve Stimulation

Other Intervention Name(s)

Intramuscular Peripheral Nerve Stimulation, Intramuscular Electrical Nerve Stimulation, SMARTPATCH System

Intervention Description

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

Intervention Name(s)

Non Contracting Producing Peripheral Nerve Stimulation

Intervention Description

Intervention Type

Other

Intervention Name(s)

Physical Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Prior 7-days] ; Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment

Secondary Outcome Measure Information:

Title

Change in Brief Pain Inventory (BPI)- Short Form (SF)

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Change in Quality of life - Short form - 12(QoL - SF 12)

Description

Time Frame

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

Title

Change Mechanical Quantitative Sensory Testing (QST)

Description

used to evaluate central sensitization

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Occurrence of Adverse events

Description

Related adverse events are documented as Safety data.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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) 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 Patients who have a tape or adhesive allergy Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc) - exclude from Magnetic resonance imaging (MRI) only

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristine Hansen, PT

Phone

216-957-3584

khansen1@metrohealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard D Wilson, MD

Organizational Affiliation

MetroHealth Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

MetroHealth Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristine Hansen, PT

First Name & Middle Initial & Last Name & Degree

Richard Wilson, MD

Facility Name

Univerity of Texas Southwestern

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samantha Frost, PT

Phone

214-648-6562

Samantha.frost@utsouthwestern.edu

First Name & Middle Initial & Last Name & Degree

Mark Newman

Mark.Newman@UTSouthwestern.edu

First Name & Middle Initial & Last Name & Degree

Nitin B Jain, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

9924205

Citation

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.

Results Reference

background

Citation

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).

Results Reference

background

PubMed Identifier

21619663

Citation

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.

Results Reference

background

PubMed Identifier

8546527

Citation

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.

Results Reference

background

PubMed Identifier

15808040

Citation

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

Results Reference

background

PubMed Identifier

20584793

Citation

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.

Results Reference

background

PubMed Identifier

19095464

Citation

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.

Results Reference

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PubMed Identifier

11885825

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

32143732

Citation

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.

Results Reference

derived

Links:

URL

http://fescenter.org/index.php

Description

Functional Electrical Stimulation (FES)Center

URL

http://www.metrohealth.org

Description

Metrohealth clinic trials

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

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