<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/NCT01735058</url>
  </required_header>
  <id_info>
    <org_study_id>13912134</org_study_id>
    <nct_id>NCT01735058</nct_id>
  </id_info>
  <brief_title>Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease</brief_title>
  <official_title>Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be performed to examine the effect of ultrasound-guided subacromial sodium&#xD;
      hyaluronate injection in patients with impingement syndrome without rotator cuff complete&#xD;
      tear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rotator cuff disease in particular is a common cause of shoulder pain and weakness and&#xD;
      comprises a significant proportion of the musculoskeletal complaints presenting to primary&#xD;
      care doctors. Ultrasound is a readily available and cheap modality for looking more&#xD;
      specifically at the rotator cuff and surrounding structures. More recently, ultrasound&#xD;
      guidance has become a commonly employed method to perform diagnostic or therapeutic&#xD;
      interventions. Despite the long history and the fact that this is a common diagnosis made in&#xD;
      clinical practice, the exact cause and best treatment for this condition still are being&#xD;
      explored. Although there are a few high-quality studies demonstrating the efficacy of sodium&#xD;
      hyaluronate injection for rotator cuff disease, this study will be performed to examine the&#xD;
      effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with&#xD;
      impingement syndrome without rotator cuff complete tear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in pain severity after 3 weeks.</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Subacromial Impingement Syndrome</condition>
  <arm_group>
    <arm_group_label>Sodium hyaluronate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided injection of sodium hyaluronate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ultrasound guided injection of normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Hyaluronate</intervention_name>
    <description>Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.</description>
    <arm_group_label>Sodium hyaluronate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.</description>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;= 18 years&#xD;
&#xD;
          -  subacromial impingement syndrome&#xD;
&#xD;
          -  without a complete tear of rotator cuff&#xD;
&#xD;
          -  willingness to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had any rheumatic disease, glenohumeral osteoarthritis, full-thickness rotator cuff&#xD;
             tears, fractures, diabetes mellitus, infections, or tumors.&#xD;
&#xD;
          -  had hypersensitivity to hyaluronate&#xD;
&#xD;
          -  had participated in any other study within 6 months&#xD;
&#xD;
          -  had received a subacromial injection within 8 weeks&#xD;
&#xD;
          -  were pregnant or planned to become pregnant&#xD;
&#xD;
          -  were at risk of complications of intra-articular injections such as patients who&#xD;
             received anti-coagulant drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farnaz Dehghan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isfahan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Farnaz Dehghan, MD</last_name>
    <email>dr.farnaz.dehghan@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Rehabilitation, Alzahra Hospital</name>
      <address>
        <city>Isfahan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alireza Moghtaderi, MD</last_name>
      <email>moghtaderia@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Alireza Moghtaderi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <reference>
    <citation>Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. doi: 10.1016/j.arthro.2004.11.003.</citation>
    <PMID>15756189</PMID>
  </reference>
  <reference>
    <citation>Meloni F, Milia F, Cavazzuti M, Doria C, Lisai P, Profili S, Meloni GB. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: experimental study of periarticular injections. Eur J Radiol. 2008 Oct;68(1):170-3. doi: 10.1016/j.ejrad.2007.11.001. Epub 2007 Dec 21.</citation>
    <PMID>18096343</PMID>
  </reference>
  <reference>
    <citation>Kim YS, Park JY, Lee CS, Lee SJ. Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study. J Shoulder Elbow Surg. 2012 Jun;21(6):722-7. doi: 10.1016/j.jse.2011.11.009. Epub 2012 Feb 25.</citation>
    <PMID>22366365</PMID>
  </reference>
  <reference>
    <citation>Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, Chang HE. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.</citation>
    <PMID>19963403</PMID>
  </reference>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>December 1, 2012</last_update_submitted>
  <last_update_submitted_qc>December 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Farnaz Dehgan Hosseinabadi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Impingement Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_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/NCT01735058
org study id: 13912134
nct id: NCT01735058
lead sponsor: 
has dmc: Yes
This study will be performed to examine the effect of ultrasound-guided subacromial sodium
      hyaluronate injection in patients with impingement syndrome without rotator cuff complete
      tear.
Rotator cuff disease in particular is a common cause of shoulder pain and weakness and
      comprises a significant proportion of the musculoskeletal complaints presenting to primary
      care doctors. Ultrasound is a readily available and cheap modality for looking more
      specifically at the rotator cuff and surrounding structures. More recently, ultrasound
      guidance has become a commonly employed method to perform diagnostic or therapeutic
      interventions. Despite the long history and the fact that this is a common diagnosis made in
      clinical practice, the exact cause and best treatment for this condition still are being
      explored. Although there are a few high-quality studies demonstrating the efficacy of sodium
      hyaluronate injection for rotator cuff disease, this study will be performed to examine the
      effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with
      impingement syndrome without rotator cuff complete tear.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in pain severity after 3 weeks.
time frame: Up to 3 weeks
description: The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week.
arm group label: Sodium hyaluronate
arm group type: Active Comparator
description: Ultrasound guided injection of sodium hyaluronate
arm group label: Normal saline
arm group type: Placebo Comparator
description: Ultrasound guided injection of normal saline
intervention type: Drug
intervention name: Sodium Hyaluronate
description: Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.
arm group label: Sodium hyaluronate
intervention type: Drug
intervention name: Normal saline
description: Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.
arm group label: Normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Farnaz Dehghan, MD
role: Principal Investigator
affiliation: Isfahan University of Medical Sciences
last name: Farnaz Dehghan, MD
email: dr.farnaz.dehghan@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Iran, Islamic Republic of
citation: Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. doi: 10.1016/j.arthro.2004.11.003.
PMID: 15756189
citation: Meloni F, Milia F, Cavazzuti M, Doria C, Lisai P, Profili S, Meloni GB. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: experimental study of periarticular injections. Eur J Radiol. 2008 Oct;68(1):170-3. doi: 10.1016/j.ejrad.2007.11.001. Epub 2007 Dec 21.
PMID: 18096343
citation: Kim YS, Park JY, Lee CS, Lee SJ. Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study. J Shoulder Elbow Surg. 2012 Jun;21(6):722-7. doi: 10.1016/j.jse.2011.11.009. Epub 2012 Feb 25.
PMID: 22366365
citation: Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, Chang HE. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.
PMID: 19963403
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Farnaz Dehgan Hosseinabadi
investigator title: Principal Investigator
mesh term: Shoulder Impingement Syndrome
mesh term: Hyaluronic Acid