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/NCT06019780</url>
    </required_header>
    <id_info>
      <org_study_id>RiphahIU Hina Yasmeen</org_study_id>
      <nct_id>NCT06019780</nct_id>
    </id_info>
    <brief_title>Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis</brief_title>
    <official_title>Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International 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 research is to determine the effect of blood flow restriction training on&#xD;
        shoulder pain, range of motion, muscle strength and shoulder. Randomized controlled trials&#xD;
        will be done at Lady Reading Hospital Peshawar and Shahab Orthopedic General Hospital. The&#xD;
        sample size is 36. The subjects will be divided in two groups, 18 subjects in BFR group and&#xD;
        18 in no BFR group. Study duration is 6 months. Sampling technique applied was non&#xD;
        probability connivance sampling technique. Tools used in the study are SPADI shoulder score,&#xD;
        NPRS, hand held dynamometer, sphygmomanometer and goniometer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Frozen shoulder is painful shoulder condition associated with stiffness and shoulder&#xD;
        disability. It is associated with reduction in forward elevation and marked external&#xD;
        rotation. Frozen shoulder is common condition effecting population between ages 30 to 60&#xD;
        years. Prevalence is more common in women than on men There are four stages of adhesive&#xD;
        capsulitis, stage1, stage 2 (freezing stage), stage 3 (frozen stage) and stage 4 (thawing&#xD;
        stage). Patient have sharp pain at end range of motion, sleep disturbances and early loss of&#xD;
        external rotation. When compared to asymptomatic subjects, patients with adhesive capsulitis&#xD;
        have higher upper trapezius to lower trapezius EMG ratios during arm elevation, indicating a&#xD;
        muscular imbalance. The scapula eventually migrates upward before 60 degrees of abduction in&#xD;
        individuals with adhesive capsulitis, resulting in the recognizable &quot;shrug sign&quot; during&#xD;
        shoulder elevation.&#xD;
  &#xD;
        Blood flow is restricted in a controlled form of vascular occlusion using external&#xD;
        tourniquet. A recent study demonstrated that augmentation of low load resistance with blood&#xD;
        flow restriction (L-L BFR) to contractile tissue can produce hypertrophy and strength gains,&#xD;
        using loads as low as 30% 1RM. BFR exercise may stimulate skeletal muscle growth and strength&#xD;
        gains through a number of different methods. These could include an increase in hormone&#xD;
        levels, an increase in the motor pathway or other intracellular signaling pathways for muscle&#xD;
        protein synthesis, an increase in satellite cell activity biomarkers, and apparent patterns&#xD;
        in fibre type recruitment.&#xD;
  &#xD;
        The purpose of this study is to provide the effects of blood flow restriction training on&#xD;
        shoulder discomfort, range of motion, muscle strength and disability in patients with&#xD;
        adhesive capsulitis. Due to pain and decrease range of motion individual with adhesive&#xD;
        capsulitis experience muscle weakness in shoulder joint. Blood flow restriction training has&#xD;
        positive effect on improvement of muscle strength and range of motion in shoulder region.&#xD;
        Blood flow restriction training has also positive effect on bone healing and bone density.&#xD;
        Therefore the study is aimed to improve the muscles strength and capsule inflammation in&#xD;
        individual with adhesive capsulitis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 25, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 30, 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>shoulder apin</measure>
      <time_frame>baseline to 4th to 8 weeks</time_frame>
      <description>the shoulder pain will be measured by NPRS, it has 11 points with 0 no pain and 10 extreme pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shoulder flexors strength</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply flexion force against isometric resistance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shoulder extensors strength</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply extension force against isometric resistance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shoulder abductors strength</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply abduction force against isometric resistance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shoulder rotation strength</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply rotation force against isometric resistance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shoulder disability (SPADI)</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>shoulder flexion</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>measures the shoulder flexion range of motion through goniometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shoulder extension</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>measures the shoulder extension range of motion through goniometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>shoulder abduction</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>measures the shoulder abduction range of motion through goniometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>shoulder adduction</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>measures the shoulder adduction range of motion through goniometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>shoulder internal rotation</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>measures the shoulder internal rotation range of motion through goniometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>shoulder external rotation</measure>
      <time_frame>baseline to 8 weeks</time_frame>
      <description>measures the shoulder external rotation range of motion through goniometry</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Adhesive Capsulitis</condition>
    <arm_group>
      <arm_group_label>Experimental interventional group A (Blood flow restriction training)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Following exercise will be performed&#xD;
  Side lying external rotation&#xD;
  Prone horizontal abduction&#xD;
  Standing scaption with pneumatic cuff for blood flow restriction</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Following exercise will be performed&#xD;
  Side lying external rotation&#xD;
  Prone horizontal abduction&#xD;
  Standing scaption without blood flow restriction</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>blood flow restriction trainin</intervention_name>
      <description>Following exercise will be performed&#xD;
  Side lying external rotation&#xD;
  Prone horizontal abduction&#xD;
  Standing scaption İndividual in the group will be having two session per week, 16 session of exercise training for 8 weeks.50% of arterial occlusion pressure (60 to 80 mmHg) will be applied for total duration of 15mins. Occlusion pressure will be calculated according to formula for each patient [Pressure=0.4x(systolic BP)+2.7x(shoulder circumference)+62].4 sets with one set of 30 repetition and three sets of 15 repetition. After each set subject will have 30 seconds of rest with cuff inflated.</description>
      <arm_group_label>Experimental interventional group A (Blood flow restriction training)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>Following exercises will be performed without application of pneumatic cuff&#xD;
  Side lying external rotation&#xD;
  Prone horizontal abduction&#xD;
  Standing scaption Conventional treatment will include: Hot pack 5 mins Maitland grade 3 and 4 mobilization: inferior glide (10reps x3sets), posterior glide (10reps x 3sets), anterior glide (10 reps x 3sets) Home plan: wand exercise, pendulum exercise, wall walking exercise (10reps x 2sets each)</description>
      <arm_group_label>Control group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Frozen shoulder (stage 2 and 3 of Kisner and Colby's classification system)&#xD;
  &#xD;
            -  Male and female&#xD;
  &#xD;
            -  Patients whose age lies between 40 and 60&#xD;
  &#xD;
            -  Ranges restriction in forward flexion (scaption) less than 100 degree and reduction of&#xD;
               external and internal rotation to less than 50% of the normal&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • History of Cardiovascular diseases&#xD;
  &#xD;
                 -  DVT patients&#xD;
  &#xD;
                 -  Hypertensive patients&#xD;
  &#xD;
                 -  Patients having neurological disease&#xD;
  &#xD;
                 -  Fracture of humerus&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aisha Razzaq, MSPT-OMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Imran Amjad, PHD</last_name>
      <phone>03324390125</phone>
      <email>imran.amjad@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shahab orthopedic general hospital</name>
        <address>
          <city>Peshawar</city>
          <state>KPK</state>
          <zip>46000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aisha Razzaq, MSPT-OMPT</last_name>
        <phone>03015030784</phone>
        <email>aisha.razzaq@riphah.edu.pk</email>
      </contact>
      <investigator>
        <last_name>HINA Yasmeen, MSPT-OMPT*</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adhesive capsulitis</keyword>
    <keyword>Blood flow restriction training</keyword>
    <keyword>Range of motion</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>No</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/NCT06019780
  org study id: RiphahIU Hina Yasmeen
  nct id: NCT06019780
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this research is to determine the effect of blood flow restriction training on
        shoulder pain, range of motion, muscle strength and shoulder. Randomized controlled trials
        will be done at Lady Reading Hospital Peshawar and Shahab Orthopedic General Hospital. The
        sample size is 36. The subjects will be divided in two groups, 18 subjects in BFR group and
        18 in no BFR group. Study duration is 6 months. Sampling technique applied was non
        probability connivance sampling technique. Tools used in the study are SPADI shoulder score,
        NPRS, hand held dynamometer, sphygmomanometer and goniometer.
  Frozen shoulder is painful shoulder condition associated with stiffness and shoulder
        disability. It is associated with reduction in forward elevation and marked external
        rotation. Frozen shoulder is common condition effecting population between ages 30 to 60
        years. Prevalence is more common in women than on men There are four stages of adhesive
        capsulitis, stage1, stage 2 (freezing stage), stage 3 (frozen stage) and stage 4 (thawing
        stage). Patient have sharp pain at end range of motion, sleep disturbances and early loss of
        external rotation. When compared to asymptomatic subjects, patients with adhesive capsulitis
        have higher upper trapezius to lower trapezius EMG ratios during arm elevation, indicating a
        muscular imbalance. The scapula eventually migrates upward before 60 degrees of abduction in
        individuals with adhesive capsulitis, resulting in the recognizable "shrug sign" during
        shoulder elevation.
  
        Blood flow is restricted in a controlled form of vascular occlusion using external
        tourniquet. A recent study demonstrated that augmentation of low load resistance with blood
        flow restriction (L-L BFR) to contractile tissue can produce hypertrophy and strength gains,
        using loads as low as 30% 1RM. BFR exercise may stimulate skeletal muscle growth and strength
        gains through a number of different methods. These could include an increase in hormone
        levels, an increase in the motor pathway or other intracellular signaling pathways for muscle
        protein synthesis, an increase in satellite cell activity biomarkers, and apparent patterns
        in fibre type recruitment.
  
        The purpose of this study is to provide the effects of blood flow restriction training on
        shoulder discomfort, range of motion, muscle strength and disability in patients with
        adhesive capsulitis. Due to pain and decrease range of motion individual with adhesive
        capsulitis experience muscle weakness in shoulder joint. Blood flow restriction training has
        positive effect on improvement of muscle strength and range of motion in shoulder region.
        Blood flow restriction training has also positive effect on bone healing and bone density.
        Therefore the study is aimed to improve the muscles strength and capsule inflammation in
        individual with adhesive capsulitis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: shoulder apin
  time frame: baseline to 4th to 8 weeks
  description: the shoulder pain will be measured by NPRS, it has 11 points with 0 no pain and 10 extreme pain.
  measure: Shoulder flexors strength
  time frame: baseline to 8 weeks
  description: this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply flexion force against isometric resistance.
  measure: Shoulder extensors strength
  time frame: baseline to 8 weeks
  description: this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply extension force against isometric resistance.
  measure: Shoulder abductors strength
  time frame: baseline to 8 weeks
  description: this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply abduction force against isometric resistance.
  measure: Shoulder rotation strength
  time frame: baseline to 8 weeks
  description: this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply rotation force against isometric resistance.
  measure: Shoulder disability (SPADI)
  time frame: baseline to 8 weeks
  description: measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
  measure: shoulder flexion
  time frame: baseline to 8 weeks
  description: measures the shoulder flexion range of motion through goniometry
  measure: Shoulder extension
  time frame: baseline to 8 weeks
  description: measures the shoulder extension range of motion through goniometry
  measure: shoulder abduction
  time frame: baseline to 8 weeks
  description: measures the shoulder abduction range of motion through goniometry
  measure: shoulder adduction
  time frame: baseline to 8 weeks
  description: measures the shoulder adduction range of motion through goniometry
  measure: shoulder internal rotation
  time frame: baseline to 8 weeks
  description: measures the shoulder internal rotation range of motion through goniometry
  measure: shoulder external rotation
  time frame: baseline to 8 weeks
  description: measures the shoulder external rotation range of motion through goniometry
  arm group label: Experimental interventional group A (Blood flow restriction training)
  arm group type: Experimental
  description: Following exercise will be performed
  Side lying external rotation
  Prone horizontal abduction
  Standing scaption with pneumatic cuff for blood flow restriction
  arm group label: Control group B
  arm group type: Active Comparator
  description: Following exercise will be performed
  Side lying external rotation
  Prone horizontal abduction
  Standing scaption without blood flow restriction
  intervention type: Other
  intervention name: blood flow restriction trainin
  description: Following exercise will be performed
  Side lying external rotation
  Prone horizontal abduction
  Standing scaption İndividual in the group will be having two session per week, 16 session of exercise training for 8 weeks.50% of arterial occlusion pressure (60 to 80 mmHg) will be applied for total duration of 15mins. Occlusion pressure will be calculated according to formula for each patient [Pressure=0.4x(systolic BP)+2.7x(shoulder circumference)+62].4 sets with one set of 30 repetition and three sets of 15 repetition. After each set subject will have 30 seconds of rest with cuff inflated.
  arm group label: Experimental interventional group A (Blood flow restriction training)
  intervention type: Other
  intervention name: exercise
  description: Following exercises will be performed without application of pneumatic cuff
  Side lying external rotation
  Prone horizontal abduction
  Standing scaption Conventional treatment will include: Hot pack 5 mins Maitland grade 3 and 4 mobilization: inferior glide (10reps x3sets), posterior glide (10reps x 3sets), anterior glide (10 reps x 3sets) Home plan: wand exercise, pendulum exercise, wall walking exercise (10reps x 2sets each)
  arm group label: Control group B
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Aisha Razzaq, MSPT-OMPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Imran Amjad, PHD
  phone: 03324390125
  email: imran.amjad@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Bursitis
  sharing ipd: No