xml: <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/NCT05988255</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004172</org_study_id>
      <nct_id>NCT05988255</nct_id>
    </id_info>
    <brief_title>Efficacy of Static Progressive Stretch Versus Traditional Stretch in Adhesive Capsulitis</brief_title>
    <official_title>Efficacy of Static Progressive Stretching Technique Versus Traditional Stretching in Primary Adhesive Capsulitis: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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>
        This study will be conducted to compare the effectiveness of static progressive stretching&#xD;
        using the joint active system (JAS) shoulder device with cyclic manual stretching and&#xD;
        controls on shoulder range of motion (ROM), time to gain ROM, and function in patients with&#xD;
        adhesive capsulitis. The study includes three groups. Group A (15 patients) will receive&#xD;
        static progressive stretch using the JAS device. Group B (15 patients) will receive cyclic&#xD;
        manual stretching in flexion, abduction, and external and internal rotations. Group C (15&#xD;
        patients) is a control group that will receive no treatment until the end of the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study design: Prospective single-blinded randomized controlled trial (therapy, level 1B).&#xD;
        A flow diagram according to the Consolidated Standards of Reporting Trials (CONSORT)&#xD;
        statement will be presented to illustrate the progression of the study.&#xD;
  &#xD;
        The sample size is calculated using G*power software (version 3.1.9.7, Franz Faul,&#xD;
        Universitat Kiel, Germany) and it suggests that 42 participants (14 per group) will be needed&#xD;
        using the MANOVA test. Cohen's d is set to be 0.25 with 80% power (alpha = 0.05) to detect an&#xD;
        effect size.&#xD;
  &#xD;
        Patients are randomly assigned to either of three groups (A, B, or C) using a&#xD;
        computer-generated list. They are allocated by an outside party who isn't involved in the&#xD;
        treatment using sequentially numbered sealed envelopes.&#xD;
  &#xD;
        Inclusion criteria: (1) Patients of both genders with unilateral primary adhesive capsulitis&#xD;
        (2) Patients aged between 40-65. (3) Pain duration of three months or more. (4) Range of&#xD;
        motion loss of greater than 25% in at least 2 planes and passive external rotation loss that&#xD;
        is greater than 50% of the uninvolved shoulder or less than 30° of external rotation.&#xD;
  &#xD;
        Exclusion criteria: (1) Previous surgery or manipulation under anesthesia. (2) Other&#xD;
        conditions affecting the shoulder as (rheumatoid arthritis, osteoarthritis, rotator cuff&#xD;
        disease, or malignancies). (3) Neurological deficits affecting shoulder function.&#xD;
  &#xD;
        Demographic data will be collected for all subjects regarding age, gender, dominance, and&#xD;
        painful side. After patient selection according to the inclusion and exclusion criteria, we&#xD;
        will measure shoulder range of motion (ROM) using a Baseline Digital Absolute Axis&#xD;
        Goniometer, and shoulder function using the SPADI scale.&#xD;
  &#xD;
        Range of motion will be assessed at baseline (before the start of treatment), at the end of&#xD;
        each week, and at the end of 12 weeks.&#xD;
  &#xD;
        Shoulder function will be assessed using SPADI at baseline (before the start of treatment)&#xD;
        and at the end of treatment.&#xD;
  &#xD;
        The mean time needed to reach ROM at 3 months will be assessed in each group and compared&#xD;
        between groups.&#xD;
  &#xD;
        Treatment procedures:&#xD;
  &#xD;
        All patients in the three groups will be educated about the natural history of the disease&#xD;
        and instructed to stay active at home through encouraging activity modification without pain.&#xD;
        Each patient in the treatment groups will receive two treatment sessions per week for a&#xD;
        series of 12 weeks.&#xD;
  &#xD;
          1. Static progressive stretching using JAS shoulder device (Group A): The static&#xD;
             progressive stretch device applies stretch toward external and internal rotation from&#xD;
             different degrees of scapular plane abduction. After adjustment of the device, it will&#xD;
             be worn for 45 minutes (30 minutes stretching toward external rotation and 15 minutes&#xD;
             toward internal rotation). The stretch position will be held for a series of 5 minutes&#xD;
             and rest in between according to patient tolerance.&#xD;
  &#xD;
          2. Cyclic manual stretching (Group B): Five to twenty seconds of stretching and 10 seconds&#xD;
             of rest will be used 10 times in each of the following directions (flexion, scapular&#xD;
             plane abduction, external rotation, and internal rotation) and stretch to target rotator&#xD;
             cuff interval. The stretching dose will be determined based on the patient's level of&#xD;
             irritability.&#xD;
  &#xD;
          3. Group C: Fifteen patients will receive no physiotherapy treatment until the end of the&#xD;
             study. As an ethical consideration, subjects in this group will receive the full&#xD;
             treatment after the end of the study after data collection.&#xD;
  &#xD;
        Statistical analysis:&#xD;
  &#xD;
        Data will be analyzed using the statistical package for social sciences (SPSS) computer&#xD;
        program version 24 software (IBM SPSS Inc., Chicago, IL, USA).&#xD;
  &#xD;
        Descriptive statistics will be expressed as mean ± standard deviation for continuous&#xD;
        variables.&#xD;
  &#xD;
        The normality of data will be examined using Kolmogorov-Smirnov statistical test.&#xD;
  &#xD;
        Repeated measures ANOVA test will be used to determine the difference between baseline and&#xD;
        post-treatment scores for the ROM and time to gain ROM within each group.&#xD;
  &#xD;
        Wilcoxon signed-rank test will be used to determine the difference between baseline and&#xD;
        post-treatment scores for pain and function.&#xD;
  &#xD;
        Kruskal Wallis ANOVA will be used for pain and function scores difference between groups&#xD;
        (ordinal data).&#xD;
  &#xD;
        A MANOVA test will be used to identify the difference between the three groups regarding ROM&#xD;
        (flexion, extension, abduction, internal rotation, external rotation in adduction, and&#xD;
        external rotation in abduction).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>
      <intervention_model_description>Prospective single-blinded randomized controlled trial (therapy, level 1B)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants will be blinded to which treatment they will receive.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Range of motion</measure>
      <time_frame>Three months</time_frame>
      <description>Shoulder flexion, extension, abduction, external rotation and internal rotation will be measured using Baseline Digital Absolute Axis Goniometer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Function</measure>
      <time_frame>Three months</time_frame>
      <description>The patient will be advised to select the number that best reflects the intensity of their discomfort and the degree of trouble they are having using the affected shoulder using SPADI.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to gain range motion</measure>
      <time_frame>Three months</time_frame>
      <description>Mean time needed to reach ROM at 3 months will be assessed in each group and compared between groups.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Adhesive Capsulitis</condition>
    <condition>Stretch</condition>
    <condition>Physical Neglect</condition>
    <arm_group>
      <arm_group_label>Static progressive stretch</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cyclic manual stretch</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>No treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Static progressive stretching</intervention_name>
      <description>A stretching technique applies a mechanical progressive stretch</description>
      <arm_group_label>Static progressive stretch</arm_group_label>
      <other_name>Stretching exercises</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cyclic manual stretching</intervention_name>
      <description>A stretching technique applies an intermittent manual stretch</description>
      <arm_group_label>Cyclic manual stretch</arm_group_label>
      <other_name>Stretching exercises</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients of both genders with unilateral primary adhesive capsulitis.&#xD;
  &#xD;
            2. Patients aged between 40-65.&#xD;
  &#xD;
            3. Pain duration of three months or more.&#xD;
  &#xD;
            4. Range of motion loss of greater than 25% in at least 2 planes and passive external&#xD;
               rotation loss that is greater than 50% of the uninvolved shoulder or less than 30° of&#xD;
               external rotation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous surgery or manipulation under anesthesia.&#xD;
  &#xD;
            2. Other conditions affecting the shoulder as (rheumatoid arthritis, osteoarthritis,&#xD;
               rotator cuff disease, or malignancies).&#xD;
  &#xD;
            3. Neurological deficits affecting shoulder function.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shaimaa R. El-Deab, Assistant lecturer</last_name>
      <phone>+201020161921</phone>
      <email>shaimaaabdulghani166@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mona M. Ahmed, Assistant professor</last_name>
      <phone>+201004046183</phone>
      <email>mona.ibrahiem@cu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of physical therapy, Cairo University</name>
        <address>
          <city>Giza</city>
          <zip>11432</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bassem El Nahass, professor</last_name>
        <phone>+21003400228</phone>
        <email>bassemelnahass@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Shaimaa Ramadan Ibrahim Abdul-ghani El Deab</investigator_full_name>
      <investigator_title>assistant lecturer</investigator_title>
    </responsible_party>
    <keyword>Adhesive capsulitis</keyword>
    <keyword>Static progressive stretch</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bursitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988255
  org study id: P.T.REC/012/004172
  nct id: NCT05988255
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will be conducted to compare the effectiveness of static progressive stretching
        using the joint active system (JAS) shoulder device with cyclic manual stretching and
        controls on shoulder range of motion (ROM), time to gain ROM, and function in patients with
        adhesive capsulitis. The study includes three groups. Group A (15 patients) will receive
        static progressive stretch using the JAS device. Group B (15 patients) will receive cyclic
        manual stretching in flexion, abduction, and external and internal rotations. Group C (15
        patients) is a control group that will receive no treatment until the end of the study.
  The study design: Prospective single-blinded randomized controlled trial (therapy, level 1B).
        A flow diagram according to the Consolidated Standards of Reporting Trials (CONSORT)
        statement will be presented to illustrate the progression of the study.
  
        The sample size is calculated using G*power software (version 3.1.9.7, Franz Faul,
        Universitat Kiel, Germany) and it suggests that 42 participants (14 per group) will be needed
        using the MANOVA test. Cohen's d is set to be 0.25 with 80% power (alpha = 0.05) to detect an
        effect size.
  
        Patients are randomly assigned to either of three groups (A, B, or C) using a
        computer-generated list. They are allocated by an outside party who isn't involved in the
        treatment using sequentially numbered sealed envelopes.
  
        Inclusion criteria: (1) Patients of both genders with unilateral primary adhesive capsulitis
        (2) Patients aged between 40-65. (3) Pain duration of three months or more. (4) Range of
        motion loss of greater than 25% in at least 2 planes and passive external rotation loss that
        is greater than 50% of the uninvolved shoulder or less than 30° of external rotation.
  
        Exclusion criteria: (1) Previous surgery or manipulation under anesthesia. (2) Other
        conditions affecting the shoulder as (rheumatoid arthritis, osteoarthritis, rotator cuff
        disease, or malignancies). (3) Neurological deficits affecting shoulder function.
  
        Demographic data will be collected for all subjects regarding age, gender, dominance, and
        painful side. After patient selection according to the inclusion and exclusion criteria, we
        will measure shoulder range of motion (ROM) using a Baseline Digital Absolute Axis
        Goniometer, and shoulder function using the SPADI scale.
  
        Range of motion will be assessed at baseline (before the start of treatment), at the end of
        each week, and at the end of 12 weeks.
  
        Shoulder function will be assessed using SPADI at baseline (before the start of treatment)
        and at the end of treatment.
  
        The mean time needed to reach ROM at 3 months will be assessed in each group and compared
        between groups.
  
        Treatment procedures:
  
        All patients in the three groups will be educated about the natural history of the disease
        and instructed to stay active at home through encouraging activity modification without pain.
        Each patient in the treatment groups will receive two treatment sessions per week for a
        series of 12 weeks.
  
          1. Static progressive stretching using JAS shoulder device (Group A): The static
             progressive stretch device applies stretch toward external and internal rotation from
             different degrees of scapular plane abduction. After adjustment of the device, it will
             be worn for 45 minutes (30 minutes stretching toward external rotation and 15 minutes
             toward internal rotation). The stretch position will be held for a series of 5 minutes
             and rest in between according to patient tolerance.
  
          2. Cyclic manual stretching (Group B): Five to twenty seconds of stretching and 10 seconds
             of rest will be used 10 times in each of the following directions (flexion, scapular
             plane abduction, external rotation, and internal rotation) and stretch to target rotator
             cuff interval. The stretching dose will be determined based on the patient's level of
             irritability.
  
          3. Group C: Fifteen patients will receive no physiotherapy treatment until the end of the
             study. As an ethical consideration, subjects in this group will receive the full
             treatment after the end of the study after data collection.
  
        Statistical analysis:
  
        Data will be analyzed using the statistical package for social sciences (SPSS) computer
        program version 24 software (IBM SPSS Inc., Chicago, IL, USA).
  
        Descriptive statistics will be expressed as mean ± standard deviation for continuous
        variables.
  
        The normality of data will be examined using Kolmogorov-Smirnov statistical test.
  
        Repeated measures ANOVA test will be used to determine the difference between baseline and
        post-treatment scores for the ROM and time to gain ROM within each group.
  
        Wilcoxon signed-rank test will be used to determine the difference between baseline and
        post-treatment scores for pain and function.
  
        Kruskal Wallis ANOVA will be used for pain and function scores difference between groups
        (ordinal data).
  
        A MANOVA test will be used to identify the difference between the three groups regarding ROM
        (flexion, extension, abduction, internal rotation, external rotation in adduction, and
        external rotation in abduction).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective single-blinded randomized controlled trial (therapy, level 1B)
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Participants will be blinded to which treatment they will receive.
  measure: Range of motion
  time frame: Three months
  description: Shoulder flexion, extension, abduction, external rotation and internal rotation will be measured using Baseline Digital Absolute Axis Goniometer
  measure: Function
  time frame: Three months
  description: The patient will be advised to select the number that best reflects the intensity of their discomfort and the degree of trouble they are having using the affected shoulder using SPADI.
  measure: Time to gain range motion
  time frame: Three months
  description: Mean time needed to reach ROM at 3 months will be assessed in each group and compared between groups.
  arm group label: Static progressive stretch
  arm group type: Experimental
  arm group label: Cyclic manual stretch
  arm group type: Active Comparator
  arm group label: No treatment
  arm group type: No Intervention
  intervention type: Device
  intervention name: Static progressive stretching
  description: A stretching technique applies a mechanical progressive stretch
  arm group label: Static progressive stretch
  other name: Stretching exercises
  intervention type: Other
  intervention name: Cyclic manual stretching
  description: A stretching technique applies an intermittent manual stretch
  arm group label: Cyclic manual stretch
  other name: Stretching exercises
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Shaimaa R. El-Deab, Assistant lecturer
  phone: +201020161921
  email: shaimaaabdulghani166@gmail.com
  last name: Mona M. Ahmed, Assistant professor
  phone: +201004046183
  email: mona.ibrahiem@cu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Shaimaa Ramadan Ibrahim Abdul-ghani El Deab
  investigator title: assistant lecturer
  mesh term: Bursitis
  sharing ipd: Undecided