<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03752619</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-00643</org_study_id>
    <nct_id>NCT03752619</nct_id>
  </id_info>
  <brief_title>Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)</brief_title>
  <official_title>Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MetroHealth Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MetroHealth Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult&#xD;
      population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain.&#xD;
      Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail&#xD;
      treatment efforts and have longstanding pain. This project will evaluate the efficacy of a&#xD;
      novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with&#xD;
      chronic shoulder pain due to subacromial impingement syndrome (SIS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The medical and socioeconomic impact of subacute and chronic shoulder pain is high, resulting&#xD;
      in 12 million visits to physicians and over $7 billion in direct costs in the United States.&#xD;
      The most common cause is subacromial impingement syndrome (SIS), which accounts for 30% of&#xD;
      all shoulder pain. Approximately 35% of patients who present with subacromial impingement&#xD;
      syndrome (SIS) are refractory to conservative management. For patients who have failed&#xD;
      conservative management, there are no established treatments to reduce the pain. The&#xD;
      long-term goal is to develop a therapeutic intervention to reduce pain related to subacromial&#xD;
      impingement syndrome(SIS). A pilot trial of 3-week percutaneous peripheral nerve stimulation&#xD;
      (PNS) for participants with chronic shoulder pain due to subacromial impingement syndrome&#xD;
      (SIS) that was refractory to conservative treatment that showed 60% of participants had&#xD;
      successful treatment of pain that lasted at least 3 months. Thus, the primary objective of&#xD;
      this 2 site randomized control trial (RCT) is to confirm the findings of this preliminary&#xD;
      trial and determine the efficacy of peripheral nerve stimulation (PNS) for chronic&#xD;
      subacromial impingement syndrome (SIS). The secondary objectives of this multisite randomized&#xD;
      control trial (RCT) is to explore mechanisms of peripheral nerve stimulation (PNS) for the&#xD;
      treatment of subacromial impingement syndrome (SIS), and to determine which characteristics&#xD;
      can predict successful treatment with peripheral nerve stimulation (PNS). In order to&#xD;
      accomplish these objectives, this trial is a multi-site, placebo controlled, double-blinded&#xD;
      randomized control trial (RCT) to compare the efficacy of peripheral nerve stimulation (PNS)&#xD;
      to sham peripheral nerve stimulation (PNS). Measures of pain, pain interference with&#xD;
      activities of daily living (ADLs), capacity for activities of daily living (ADLs), Quality of&#xD;
      life (QoL), and measures of central sensitization (pain thresholds, secondary hyperalgesia,&#xD;
      and temporal summation) will be measured. Participants will be followed for a total of 24&#xD;
      weeks after treatment has concluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in - Short Form (SF) question 3 (BPI-SF3)</measure>
    <time_frame>Prior 7-days] ; Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment</time_frame>
    <description>The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the &quot;pain worst&quot; 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 &quot;0&quot; indicates &quot;No pain&quot; and &quot;10&quot; indicates &quot;Pain as bad as you can imagine.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Brief Pain Inventory (BPI)- Short Form (SF)</measure>
    <time_frame>Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment</time_frame>
    <description>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 &quot;0&quot; indicates &quot;No pain&quot; and &quot;10&quot; indicates &quot;Pain as bad as you can imagine.&quot; .&quot; In addition, the question asks the participant to rate how their pain interferes with daily activities where &quot;0&quot; indicates &quot;does not interfere and &quot;10&quot; indicates &quot;completely interferes&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Activities of Daily Living(ADL( capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)</measure>
    <time_frame>Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Activities of Daily Living (ADL) performance -Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life - Short form - 12(QoL - SF 12)</measure>
    <time_frame>Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Mechanical Quantitative Sensory Testing (QST)</measure>
    <time_frame>Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment</time_frame>
    <description>used to evaluate central sensitization</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Occurrence of Adverse events</measure>
    <time_frame>Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment</time_frame>
    <description>Related adverse events are documented as Safety data.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Shoulder Pain</condition>
  <condition>Shoulder Impingement Syndrome</condition>
  <condition>Shoulder Tendinitis</condition>
  <condition>Shoulder Bursitis</condition>
  <condition>Pain, Shoulder</condition>
  <arm_group>
    <arm_group_label>Contraction Producing Peripheral Nerve Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Contracting Producing Peripheral Nerve Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contracting Producing Peripheral Nerve Stimulation</intervention_name>
    <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.</description>
    <arm_group_label>Contraction Producing Peripheral Nerve Stimulation</arm_group_label>
    <other_name>Intramuscular Peripheral Nerve Stimulation</other_name>
    <other_name>Intramuscular Electrical Nerve Stimulation</other_name>
    <other_name>SMARTPATCH System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non Contracting Producing Peripheral Nerve Stimulation</intervention_name>
    <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.</description>
    <arm_group_label>Non Contracting Producing Peripheral Nerve Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <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.</description>
    <arm_group_label>Contraction Producing Peripheral Nerve Stimulation</arm_group_label>
    <arm_group_label>Non Contracting Producing Peripheral Nerve Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Shoulder pain of &gt;3 months&#xD;
&#xD;
          2. Age&gt;=21&#xD;
&#xD;
          3. Worst pain in the last week&gt;=4 (0-10 scale)&#xD;
&#xD;
          4. Ability to check skin and perform dressing changes, independently or with assistance&#xD;
&#xD;
          5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid&#xD;
             analgesic)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current shoulder joint or overlying skin infection, or current bacterial infection&#xD;
             requiring antibiotics&#xD;
&#xD;
          2. Other chronic pain syndrome (Pain in another area of the body 15 or more days in the&#xD;
             last 30 (more than half of the time) or taking daily analgesics for another pain&#xD;
             syndrome)&#xD;
&#xD;
          3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff,&#xD;
             acromioclavicular (AC) Joint, etc.)&#xD;
&#xD;
          4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving&#xD;
             treatment in last 12 weeks&#xD;
&#xD;
          5. Uncontrolled bleeding disorder&#xD;
&#xD;
          6. Medical instability based on physician opinion after review of medical information&#xD;
&#xD;
          7. Pregnancy&#xD;
&#xD;
          8. Neurological condition affecting ipsilateral upper limb (such as central neurologic&#xD;
             injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome,&#xD;
             etc.)&#xD;
&#xD;
          9. Current Worker's compensation claim for the ipsilateral shoulder&#xD;
&#xD;
         10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms&#xD;
             and physical examination&#xD;
&#xD;
         11. Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing&#xD;
             height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile&#xD;
             (e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by&#xD;
             another person))&#xD;
&#xD;
         12. Current osseus fracture in ipsilateral arm&#xD;
&#xD;
         13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or&#xD;
             full)&#xD;
&#xD;
         14. Surgical indication for shoulder treatment based on physician opinion&#xD;
&#xD;
         15. Compromised immune system (immunodeficiency or immunosuppression)&#xD;
&#xD;
         16. Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant&#xD;
             (e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose&#xD;
             stimulus current pathway may overlap with that of the SPRINT System&#xD;
&#xD;
         17. Patients who have a tape or adhesive allergy&#xD;
&#xD;
         18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body&#xD;
             habitus, etc) - exclude from Magnetic resonance imaging (MRI) only&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard D Wilson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MetroHealth Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kristine Hansen, PT</last_name>
    <phone>216-957-3584</phone>
    <email>khansen1@metrohealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristine Hansen, PT</last_name>
    </contact>
    <investigator>
      <last_name>Richard Wilson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Univerity of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samantha Frost, PT</last_name>
      <phone>214-648-6562</phone>
      <email>Samantha.frost@utsouthwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mark Newman</last_name>
      <email>Mark.Newman@UTSouthwestern.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Nitin B Jain, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://fescenter.org/index.php</url>
    <description>Functional Electrical Stimulation (FES)Center</description>
  </link>
  <link>
    <url>http://www.metrohealth.org</url>
    <description>Metrohealth clinic trials</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>9924205</PMID>
  </reference>
  <reference>
    <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).</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21619663</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>8546527</PMID>
  </reference>
  <reference>
    <citation>Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.</citation>
    <PMID>15808040</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20584793</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19095464</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11885825</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11129754</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>9160946</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>January 20, 2023</last_update_submitted>
  <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MetroHealth Medical Center</investigator_affiliation>
    <investigator_full_name>Richard Wilson, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>peripheral nerve stimulation</keyword>
  <keyword>Sprint</keyword>
  <keyword>stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Shoulder Impingement Syndrome</mesh_term>
    <mesh_term>Bursitis</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03752619
org study id: IRB17-00643
nct id: NCT03752619
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: 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
description: 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."
measure: 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
description: 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".
measure: 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
description: 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
measure: 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
description: 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.
measure: 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
description: 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.
measure: Change Mechanical Quantitative Sensory Testing (QST)
time frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
description: used to evaluate central sensitization
measure: Occurrence of Adverse events
time frame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
description: Related adverse events are documented as Safety data.
arm group label: Contraction Producing Peripheral Nerve Stimulation
arm group type: Experimental
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 group label: Non Contracting Producing Peripheral Nerve Stimulation
arm group type: Active Comparator
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: Contracting Producing Peripheral Nerve Stimulation
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.
arm group label: Contraction Producing Peripheral Nerve Stimulation
other name: Intramuscular Peripheral Nerve Stimulation
other name: Intramuscular Electrical Nerve Stimulation
other name: SMARTPATCH System
intervention type: Device
intervention name: Non Contracting Producing Peripheral Nerve Stimulation
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.
arm group label: Non Contracting Producing Peripheral Nerve Stimulation
intervention type: Other
intervention name: Physical Therapy
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.
arm group label: Contraction Producing Peripheral Nerve Stimulation
arm group label: Non Contracting Producing Peripheral Nerve Stimulation
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard D Wilson, MD
role: Principal Investigator
affiliation: MetroHealth Medical Center
last name: Kristine Hansen, PT
phone: 216-957-3584
email: khansen1@metrohealth.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
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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PMID: 8546527
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PMID: 15808040
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PMID: 20584793
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.
PMID: 19095464
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.
PMID: 11885825
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PMID: 9160946
responsible party type: Principal Investigator
investigator affiliation: MetroHealth Medical Center
investigator full name: Richard Wilson, MD
investigator title: Principal Investigator
mesh term: Shoulder Pain
mesh term: Tendinopathy
mesh term: Shoulder Impingement Syndrome
mesh term: Bursitis
mesh term: Syndrome
mesh term: Rotator Cuff Injuries