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

• ClinicalTrials.gov Identifier: NCT03752619
• Recruitment Status: Recruiting
• First Posted: November 26, 2018
• Last Update Posted: January 23, 2023
• Sponsor: MetroHealth Medical Center
• Collaborator: University of Texas
• Information provided by (Responsible Party): Richard Wilson, MD, MetroHealth Medical Center

Tracking Information

• First Submitted Date: November 20, 2018
• First Posted Date: November 26, 2018
• Last Update Posted Date: January 23, 2023
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: January 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2018)

Change in - Short Form (SF) question 3 (BPI-SF3) [ Time Frame: Prior 7-days] ; Baseline (week 1), End of Treatment(week 5), 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."

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 21, 2018)

• Change in Brief Pain Inventory (BPI)- Short Form (SF) [ Time Frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment ]
  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) [ 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
• 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 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) [ 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 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) [ Time Frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment ]
  used to evaluate central sensitization

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: November 21, 2018)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
• Official Title: Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

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

Intervention

• 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
• 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.
• 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.

Study Arms

• 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.
  Interventions:

  • Device: Contracting Producing Peripheral Nerve Stimulation
  • Other: Physical Therapy
• 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.
  Interventions:

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

Publications *

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 21, 2018): 116
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2024
• Estimated Primary Completion Date: January 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Kristine Hansen, PT; 216-957-3584; khansen1@metrohealth.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03752619
• Other Study ID Numbers: IRB17-00643
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Richard Wilson, MD, MetroHealth Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: MetroHealth Medical Center
• Original Study Sponsor: Same as current
• Collaborators: University of Texas

Investigators

• Principal Investigator: Richard D Wilson, MD; MetroHealth Medical Center

• PRS Account: MetroHealth Medical Center
• Verification Date: January 2023