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/NCT05963789</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004185</org_study_id>
      <nct_id>NCT05963789</nct_id>
    </id_info>
    <brief_title>Cervical Proprioception and Shoulder Impingement Treatment</brief_title>
    <official_title>Efficacy of Cervical Proprioceptive Exercises in Treating Shoulder Impingement Syndrome</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>Yes</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 will be to investigate the role of cervical proprioceptive training on&#xD;
        shoulder proprioception, pain, and disability in shoulder impingement syndrome patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design: This study will be randomized controlled trial 1. Participants: fifty males and&#xD;
        females patients with functional shoulder impingement, aged from 25-40 years with BMI&#xD;
        &lt;32kg/m2. Sample size calculation: The sample size is 50 patients in the 2 experimental&#xD;
        groups based on power analysis done calculating effect size from outcomes of previous study&#xD;
        (effect size d of 0.82 for shoulder proprioception) . Power analysis was done using G*power&#xD;
        software. Power set to (0.8), significance (0.05). Procedture: First, eligible patients will&#xD;
        have the purpose of the study and the procedures fully explained. Then, patients will be&#xD;
        asked to participate in the study. If they accepted, an informed consent form will be signed&#xD;
        and randomly assigned in one of two groups. Afterwards Prior to starting of the study each&#xD;
        patient will sign informed consent Patients will be assigned to two groups randomly (by&#xD;
        closed envelope method). All subjects will be evaluated for their shoulder pain, disability&#xD;
        level, and proprioception. All patients will be tested before and after the treatment program&#xD;
        (12 treatment sessions, 3 sessions per week for 4 weeks) Conventional Physical therapy: a.&#xD;
        Cross-body stretch b. Sleeper stretch. c. Prone extension with an externally rotated (thumb&#xD;
        out) position d. Prone horizontal abduction e. PNF D2 flexion For intervention group it will&#xD;
        take Cervical proprioceptive training Retraining joint position sense will be done with a&#xD;
        laser pointer. The laser pointer will fixed on the highest point of the subject head with a&#xD;
        band. In this exercise, patients sit upright on a chair and kept their head at the neutral&#xD;
        position while setting the laser light at the point on the wall in front of them. From this&#xD;
        position, patients will be asked to flex, extend and rotate their head and then return to the&#xD;
        neutral position. This training commenced with open eyes and then progress with closed eyes,&#xD;
        tracing a pattern and standing position . Temporary reproduction of dizziness is acceptable&#xD;
        however exacerbation of neck pain or headache is not acceptable. If this occurs the exercises&#xD;
        should be modified by decreasing the number of repetitions or altering the patient position&#xD;
        to a more supported position. Progression of exercise set can be achieved by altering the&#xD;
        duration, repetitions and the degree of difficulty of the task. Exercises can also be&#xD;
        progressed by performing activities such as an eye task or cervical JPS practice while&#xD;
        sitting on an unstable surface or while standing with the feet in an unstable base of support&#xD;
        for example, heel toe stance, or while walking .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Shoulder proprioception</measure>
      <time_frame>4 weeks</time_frame>
      <description>Joint position sense (Active joint angular reproduction) will be measured with bubble inclinometer during shoulder IR and ER 300 as reference angles from modified neutral position of the arm (shoulder abducted 30O, horizontally adducted 30O and elbow flexed 90o), visual cues are often negated.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain and disability</measure>
      <time_frame>4 weeks</time_frame>
      <description>Participants will fill the questionnaire of shoulder pain and disability index (SPADI, . Scores will be calculated as follow, scores in all questions will be added in each section separately.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cervical proprioception</measure>
      <time_frame>4 weeks</time_frame>
      <description>Cervical active JPS will be measured using Revel's laser method to record joint position error (JPE). Cervical Joint Position Error (JPE) is the ability to relocate the head to a beginning position following a dynamic active cervical range of motion.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Shoulder Impingement</condition>
    <condition>Shoulder Pain</condition>
    <arm_group>
      <arm_group_label>Group A or cervical proprioception group CPG</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive traditional exercises for shoulder impingement plus cervical proprioception exercises using laser pointer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B or control group CG</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive traditional exercises for shoulder impingement (stretching, strengthening, stabilization)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cervical proprioceptive training</intervention_name>
      <description>Cervical proprioceptive training: The laser pointer will fixed on the highest point of the subject head with a band, patients sit upright on a chair and kept their head at the neutral position, while setting the laser light at the point on the wall in front of them. From this position, patients will be asked to flex, extend and rotate their head and then return to the neutral position. This training commenced with open eyes and then progress with closed eyes, tracing a pattern and standing position.</description>
      <arm_group_label>Group A or cervical proprioception group CPG</arm_group_label>
      <other_name>Traditional exercises</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional exercises</intervention_name>
      <description>Stretching posterior shoulder capsule Strengthening scapular muscles Shoulder stabilization PNF</description>
      <arm_group_label>Group B or control group CG</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Shoulder impingement syndrome (defined as patients with at least 3 out of the&#xD;
               following 6 criteria; Positive &quot;Neer's sign&quot;, Positive &quot;Hawkins' sign&quot;, Pain with&#xD;
               active shoulder elevation in the scapular plane, Pain in the C5-C6 dermatome, Pain&#xD;
               with palpation of the rotator cuff tendons, and Pain with resisted isometric&#xD;
               abduction.&#xD;
  &#xD;
            -  Patients with positive apprehension sign for anterior instability.&#xD;
  &#xD;
            -  Age 25-40years. 4-BMI&lt;32 kg/m2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Shoulder osteoarthritis&#xD;
  &#xD;
                 -  Shoulder trauma&#xD;
  &#xD;
            -  Shoulder infection&#xD;
  &#xD;
            -  Intra-articular corticosteroid or hyaluronic acid injection within the last 3 months.&#xD;
  &#xD;
            -  Previous surgery of the affected shoulder. - Symptomatic cervical pathology.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abdel Majeed</last_name>
      <role>Principal Investigator</role>
      <affiliation>Professor at orthopedic department, faculty of physical therapy, Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Salwa F Abdel Majeed</last_name>
      <phone>01008565476</phone>
      <email>dr_Salwa_fadl@live.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fatma eldesoky Ramadan</name>
        <address>
          <city>Cairo</city>
          <state>Al Qahirah</state>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fatma Eldesoki, Doctoral</last_name>
        <phone>01157564905</phone>
        <email>fatmadesoqipt1990@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Fatma Eldesoky, Doctoral</last_name>
        <phone>01157564905</phone>
        <email>fatmadesoqipt1990@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Fatma eldesoky</investigator_full_name>
      <investigator_title>Physiotherapist at 23rd of July hospital, PhD candidate physiotherapy, Cairo university</investigator_title>
    </responsible_party>
    <keyword>Cervical Proprioceptive Exercises</keyword>
    <keyword>Shoulder pain</keyword>
    <keyword>Shoulder disability</keyword>
    <keyword>Shoulder proprioception</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shoulder Pain</mesh_term>
      <mesh_term>Shoulder Impingement Syndrome</mesh_term>
    </condition_browse>
    <!-- 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/NCT05963789
  org study id: P.T.REC/012/004185
  nct id: NCT05963789
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study will be to investigate the role of cervical proprioceptive training on
        shoulder proprioception, pain, and disability in shoulder impingement syndrome patients
  Study design: This study will be randomized controlled trial 1. Participants: fifty males and
        females patients with functional shoulder impingement, aged from 25-40 years with BMI
        <32kg/m2. Sample size calculation: The sample size is 50 patients in the 2 experimental
        groups based on power analysis done calculating effect size from outcomes of previous study
        (effect size d of 0.82 for shoulder proprioception) . Power analysis was done using G*power
        software. Power set to (0.8), significance (0.05). Procedture: First, eligible patients will
        have the purpose of the study and the procedures fully explained. Then, patients will be
        asked to participate in the study. If they accepted, an informed consent form will be signed
        and randomly assigned in one of two groups. Afterwards Prior to starting of the study each
        patient will sign informed consent Patients will be assigned to two groups randomly (by
        closed envelope method). All subjects will be evaluated for their shoulder pain, disability
        level, and proprioception. All patients will be tested before and after the treatment program
        (12 treatment sessions, 3 sessions per week for 4 weeks) Conventional Physical therapy: a.
        Cross-body stretch b. Sleeper stretch. c. Prone extension with an externally rotated (thumb
        out) position d. Prone horizontal abduction e. PNF D2 flexion For intervention group it will
        take Cervical proprioceptive training Retraining joint position sense will be done with a
        laser pointer. The laser pointer will fixed on the highest point of the subject head with a
        band. In this exercise, patients sit upright on a chair and kept their head at the neutral
        position while setting the laser light at the point on the wall in front of them. From this
        position, patients will be asked to flex, extend and rotate their head and then return to the
        neutral position. This training commenced with open eyes and then progress with closed eyes,
        tracing a pattern and standing position . Temporary reproduction of dizziness is acceptable
        however exacerbation of neck pain or headache is not acceptable. If this occurs the exercises
        should be modified by decreasing the number of repetitions or altering the patient position
        to a more supported position. Progression of exercise set can be achieved by altering the
        duration, repetitions and the degree of difficulty of the task. Exercises can also be
        progressed by performing activities such as an eye task or cervical JPS practice while
        sitting on an unstable surface or while standing with the feet in an unstable base of support
        for example, heel toe stance, or while walking .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Shoulder proprioception
  time frame: 4 weeks
  description: Joint position sense (Active joint angular reproduction) will be measured with bubble inclinometer during shoulder IR and ER 300 as reference angles from modified neutral position of the arm (shoulder abducted 30O, horizontally adducted 30O and elbow flexed 90o), visual cues are often negated.
  measure: Pain and disability
  time frame: 4 weeks
  description: Participants will fill the questionnaire of shoulder pain and disability index (SPADI, . Scores will be calculated as follow, scores in all questions will be added in each section separately.
  measure: Cervical proprioception
  time frame: 4 weeks
  description: Cervical active JPS will be measured using Revel's laser method to record joint position error (JPE). Cervical Joint Position Error (JPE) is the ability to relocate the head to a beginning position following a dynamic active cervical range of motion.
  arm group label: Group A or cervical proprioception group CPG
  arm group type: Experimental
  description: Patients will receive traditional exercises for shoulder impingement plus cervical proprioception exercises using laser pointer
  arm group label: Group B or control group CG
  arm group type: Active Comparator
  description: Patients will receive traditional exercises for shoulder impingement (stretching, strengthening, stabilization)
  intervention type: Other
  intervention name: Cervical proprioceptive training
  description: Cervical proprioceptive training: The laser pointer will fixed on the highest point of the subject head with a band, patients sit upright on a chair and kept their head at the neutral position, while setting the laser light at the point on the wall in front of them. From this position, patients will be asked to flex, extend and rotate their head and then return to the neutral position. This training commenced with open eyes and then progress with closed eyes, tracing a pattern and standing position.
  arm group label: Group A or cervical proprioception group CPG
  other name: Traditional exercises
  intervention type: Other
  intervention name: Traditional exercises
  description: Stretching posterior shoulder capsule Strengthening scapular muscles Shoulder stabilization PNF
  arm group label: Group B or control group CG
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Abdel Majeed
  role: Principal Investigator
  affiliation: Professor at orthopedic department, faculty of physical therapy, Cairo University
  last name: Salwa F Abdel Majeed
  phone: 01008565476
  email: dr_Salwa_fadl@live.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Fatma eldesoky
  investigator title: Physiotherapist at 23rd of July hospital, PhD candidate physiotherapy, Cairo university
  mesh term: Shoulder Pain
  mesh term: Shoulder Impingement Syndrome