<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/NCT04454632</url>
  </required_header>
  <id_info>
    <org_study_id>Dr. Lutfi Kirdar Hospital</org_study_id>
    <nct_id>NCT04454632</nct_id>
  </id_info>
  <brief_title>The Effect of Mirror Therapy in Patients With Frozen Shoulder</brief_title>
  <official_title>Examination of the Effectiveness of Mirror Therapy in the Treatment of Patients With Frozen Shoulder: A Prospective Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study compares mirror therapy and visual feedback treatment with the control&#xD;
      group in frozen shoulder patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty-six individuals divided three groups as mirror therapy, visual feedback, and control&#xD;
      groups were included in the study for 15 sessions of treatment. All individuals received&#xD;
      basic treatment as ultrasound, transcutaneous electrical nerve stimulation, cold pack,&#xD;
      stretching exercises, glenohumeral range of motion exercises, scapulothoracic exercises. The&#xD;
      mirror group bilateral exercised with an affected arm behind the mirror; visual feedback&#xD;
      group bilateral exercised by seeing both arms in the mirror; control group bilateral&#xD;
      exercised without a mirror for 10 minutes after every session. Pain severity was evaluated&#xD;
      with the &quot;Visual Analogue Scale (VAS)&quot;, ROM and proprioception were measured with a universal&#xD;
      goniometer, and functional status was evaluated with &quot;shoulder pain and disability index&#xD;
      (SPADI)&quot; and &quot;Modified Constant Score&quot;. Evaluations were made before, day after the treatment&#xD;
      and 4 weeks after the treatment by the same researcher. Data analysis was performed with&#xD;
      SPSS.23.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2018</start_date>
  <completion_date type="Actual">June 27, 2019</completion_date>
  <primary_completion_date type="Actual">May 29, 2019</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>Change from Baseline, 6 weeks and 10 weeks</time_frame>
    <description>Pain intensity was obtained using a Visual Analog Scale (VAS). VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with &quot;No Pain&quot; (score of zero) on the left side up to &quot;severe pain&quot; on the right side. The patient was asked to mark the line point that represented his or her worst pain in the past week during daily rutine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion (ROM)</measure>
    <time_frame>Change from Baseline, 6 weeks and 10 weeks</time_frame>
    <description>Range of motion is the measurement of the amount of movement around a joint as a flexion, abduction, external rotation and internal rotation (degree). Measurement performed with universal goniometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proprioception</measure>
    <time_frame>Change from Baseline, 6 weeks and 10 weeks</time_frame>
    <description>Proprioception is the sense of self-movement and body position. A joint position error test (JPET) was used for proprioception measurement. JPET is a deviation of the ability to reposition the joint to the target position which fifty percent of active flexion ROM.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>Change from Baseline, 6 weeks and 10 weeks</time_frame>
    <description>The shoulder pain and disability index is a self-administered questionnaire that consists of two dimensions, one for pain and the other one for functional activities on the shoulder. The total score is defining as a percent. 0 for best score 100 for worst score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Constant-Murley Score (CMS)</measure>
    <time_frame>Change from Baseline, 6 weeks and 10 weeks</time_frame>
    <description>The modified Constant-Murley score is a questionnaire for shoulder injuries that consists of four dimensions, pain, activities of daily living, range of movement, and power. Pain and activities of daily living are considered subjective scores therefore the range of movement and power considered objective score. 100 for best score 0 for worst score.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Pain</condition>
  <condition>Frozen Shoulder</condition>
  <arm_group>
    <arm_group_label>Mirror therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The number of participants in this group is anticipated to be 12. In addition to basic treatment, the mirror therapy group bilateral exercised with the affected arm behind the mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Visual feedback group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The number of participants in this group is anticipated to be 12. In addition to basic treatment, the visual feedback group bilateral exercised by seeing both arms in the mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation while seeing both arms in the mirror.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The number of participants in this group is anticipated to be 12. In addition to basic treatment, the control group bilateral exercised without a mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation while seeing both arms in the mirror.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mirror therapy</intervention_name>
    <description>affected arm stay behind the mirror while exercising</description>
    <arm_group_label>Mirror therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Visual feedback</intervention_name>
    <description>visual feedback from mirror</description>
    <arm_group_label>Visual feedback group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who were diagnosed with &quot;Unilateral Frozen Shoulder&quot; by the specialist;&#xD;
&#xD;
          -  Normal radiological imaging;&#xD;
&#xD;
          -  Aged between 18-75 years old;&#xD;
&#xD;
          -  Symptoms persist for 2-12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If patients had following comorbidities: rotator cuff injury, cervical radiculopathy,&#xD;
             romatological diseases, neurological diseases, fracture, tumour, congenital&#xD;
             deformities, dislocation or sublocation, surgery in the shoulder, uncontrolled&#xD;
             hypertension or diabetes mellitus;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Patients who had previously received physical therapy;&#xD;
&#xD;
          -  Patients having problems in the perception of tests and exercises were excluded from&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TUGBA KURU ÇOLAK, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Lutfi Kirdar City Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Kartal</state>
        <zip>34865</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/30056414/</url>
    <description>Mirror therapy in frozen shoulder</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/20202141/</url>
    <description>visual feedback therapy</description>
  </link>
  <results_reference>
    <citation>Baskaya MC, Ercalik C, Karatas Kir O, Ercalik T, Tuncer T. The efficacy of mirror therapy in patients with adhesive capsulitis: A randomized, prospective, controlled study. J Back Musculoskelet Rehabil. 2018;31(6):1177-1182. doi: 10.3233/BMR-171050.</citation>
    <PMID>30056414</PMID>
  </results_reference>
  <results_reference>
    <citation>Sato K, Fukumori S, Matsusaki T, Maruo T, Ishikawa S, Nishie H, Takata K, Mizuhara H, Mizobuchi S, Nakatsuka H, Matsumi M, Gofuku A, Yokoyama M, Morita K. Nonimmersive virtual reality mirror visual feedback therapy and its application for the treatment of complex regional pain syndrome: an open-label pilot study. Pain Med. 2010 Apr;11(4):622-9. doi: 10.1111/j.1526-4637.2010.00819.x. Epub 2010 Mar 1.</citation>
    <PMID>20202141</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Frozen Shoulder</keyword>
  <keyword>visual feedback</keyword>
  <keyword>proprioception</keyword>
  <keyword>pain insensitivity</keyword>
  <keyword>shoulder pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</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/NCT04454632
org study id: Dr. Lutfi Kirdar Hospital
nct id: NCT04454632
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study compares mirror therapy and visual feedback treatment with the control
      group in frozen shoulder patients.
Thirty-six individuals divided three groups as mirror therapy, visual feedback, and control
      groups were included in the study for 15 sessions of treatment. All individuals received
      basic treatment as ultrasound, transcutaneous electrical nerve stimulation, cold pack,
      stretching exercises, glenohumeral range of motion exercises, scapulothoracic exercises. The
      mirror group bilateral exercised with an affected arm behind the mirror; visual feedback
      group bilateral exercised by seeing both arms in the mirror; control group bilateral
      exercised without a mirror for 10 minutes after every session. Pain severity was evaluated
      with the "Visual Analogue Scale (VAS)", ROM and proprioception were measured with a universal
      goniometer, and functional status was evaluated with "shoulder pain and disability index
      (SPADI)" and "Modified Constant Score". Evaluations were made before, day after the treatment
      and 4 weeks after the treatment by the same researcher. Data analysis was performed with
      SPSS.23.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analog Scale (VAS)
time frame: Change from Baseline, 6 weeks and 10 weeks
description: Pain intensity was obtained using a Visual Analog Scale (VAS). VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "severe pain" on the right side. The patient was asked to mark the line point that represented his or her worst pain in the past week during daily rutine.
measure: Range of Motion (ROM)
time frame: Change from Baseline, 6 weeks and 10 weeks
description: Range of motion is the measurement of the amount of movement around a joint as a flexion, abduction, external rotation and internal rotation (degree). Measurement performed with universal goniometer.
measure: Proprioception
time frame: Change from Baseline, 6 weeks and 10 weeks
description: Proprioception is the sense of self-movement and body position. A joint position error test (JPET) was used for proprioception measurement. JPET is a deviation of the ability to reposition the joint to the target position which fifty percent of active flexion ROM.
measure: Shoulder Pain and Disability Index (SPADI)
time frame: Change from Baseline, 6 weeks and 10 weeks
description: The shoulder pain and disability index is a self-administered questionnaire that consists of two dimensions, one for pain and the other one for functional activities on the shoulder. The total score is defining as a percent. 0 for best score 100 for worst score.
measure: Modified Constant-Murley Score (CMS)
time frame: Change from Baseline, 6 weeks and 10 weeks
description: The modified Constant-Murley score is a questionnaire for shoulder injuries that consists of four dimensions, pain, activities of daily living, range of movement, and power. Pain and activities of daily living are considered subjective scores therefore the range of movement and power considered objective score. 100 for best score 0 for worst score.
arm group label: Mirror therapy group
arm group type: Experimental
description: The number of participants in this group is anticipated to be 12. In addition to basic treatment, the mirror therapy group bilateral exercised with the affected arm behind the mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation.
arm group label: Visual feedback group
arm group type: Experimental
description: The number of participants in this group is anticipated to be 12. In addition to basic treatment, the visual feedback group bilateral exercised by seeing both arms in the mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation while seeing both arms in the mirror.
arm group label: Control group
arm group type: No Intervention
description: The number of participants in this group is anticipated to be 12. In addition to basic treatment, the control group bilateral exercised without a mirror for 10 minutes after every session. Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation while seeing both arms in the mirror.
intervention type: Other
intervention name: Mirror therapy
description: affected arm stay behind the mirror while exercising
arm group label: Mirror therapy group
intervention type: Other
intervention name: Visual feedback
description: visual feedback from mirror
arm group label: Visual feedback group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: TUGBA KURU ÇOLAK, Assoc. Prof.
role: Study Director
affiliation: Marmara University
facility: 
country: Turkey
url: https://pubmed.ncbi.nlm.nih.gov/30056414/
description: Mirror therapy in frozen shoulder
url: https://pubmed.ncbi.nlm.nih.gov/20202141/
description: visual feedback therapy
citation: Baskaya MC, Ercalik C, Karatas Kir O, Ercalik T, Tuncer T. The efficacy of mirror therapy in patients with adhesive capsulitis: A randomized, prospective, controlled study. J Back Musculoskelet Rehabil. 2018;31(6):1177-1182. doi: 10.3233/BMR-171050.
PMID: 30056414
citation: Sato K, Fukumori S, Matsusaki T, Maruo T, Ishikawa S, Nishie H, Takata K, Mizuhara H, Mizobuchi S, Nakatsuka H, Matsumi M, Gofuku A, Yokoyama M, Morita K. Nonimmersive virtual reality mirror visual feedback therapy and its application for the treatment of complex regional pain syndrome: an open-label pilot study. Pain Med. 2010 Apr;11(4):622-9. doi: 10.1111/j.1526-4637.2010.00819.x. Epub 2010 Mar 1.
PMID: 20202141
responsible party type: Sponsor
mesh term: Bursitis