<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/NCT04468594</url>
  </required_header>
  <id_info>
    <org_study_id>1234567890</org_study_id>
    <nct_id>NCT04468594</nct_id>
  </id_info>
  <brief_title>Rigid Taping Versus Scapular Stabilizing Exercises in Subacromial Impingement Syndrome</brief_title>
  <official_title>The Effect of Rigid Taping Versus Scapular Stabilizing Exercises on Pain and Function in Patients With Shoulder Subacromial Impingement Syndrome: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hail</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taif University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Hail</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 current study tends to compare the effect of two different treatment techniques used in&#xD;
      the rehabilitation of shoulder impingement syndrome. rigid tapping and scapular stabilizing&#xD;
      exercises will be applied and the level of function and pain intensity will be measured&#xD;
      before and after the intervention and at 3 months follow up. while both methods of treatment&#xD;
      used previously, the comparison between their effects is not yet investigated and no data is&#xD;
      available regarding the superiority of one over the other.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be recruited through a verbal and written announcement from the customers of a&#xD;
      local out-patient clinic. The appropriate number of patients, diagnosed with SIS, who will&#xD;
      meet the inclusion criteria and accept to sign a consent form will join the study.&#xD;
&#xD;
      patients will be assigned randomly into three equal groups using permuted blocks of variable&#xD;
      sizes. The first group rigid tape (RT) group will receive rigid taping plus a standard&#xD;
      physical therapy protocol. The second group scapular stabilizing exercises (SSE) group will&#xD;
      receive scapular stabilizing exercises plus the same standard protocol, and the third group&#xD;
      (control group) will receive the standard protocol only.&#xD;
&#xD;
      The inclusion criteria were: positive 4 out of the following clinical signs: empty can test,&#xD;
      Hawkins sign, Neer' sign, tenderness upon palpation of the greater tuberosity of the humerus,&#xD;
      and painful movement between 60°_ and 120°(painful arc) Patients will be excluded if they&#xD;
      demonstrate a previous history of shoulder surgery, cervical spine involvement, upper-limb&#xD;
      fracture, adhesive capsulitis, joint instability, intraarticular corticosteroids injections&#xD;
      within the last 2 months During the first interview, all patients will be checked for&#xD;
      inclusion criteria. then undergo baseline assessment for pain level using a validated version&#xD;
      of the Visual Analog Scale (VAS). Moreover, the functional level of the shoulder will be&#xD;
      assessed using shoulder pain and disability index (SPADI). SPADI is a valid and reliable&#xD;
      scale. it has a score ranging from 0 (normal) to 100 (complete disability). Pain and&#xD;
      functional level will be assessed again after the end of the treatment period and after 3&#xD;
      months (following up) 12 weeks-rehabilitation program will be implemented for all patients&#xD;
      with a frequency of 3 sessions/week. The RT group will receive a bilateral rigid taping&#xD;
      technique using zinc oxide tape and along with the protective tape. With the participant&#xD;
      assuming a relaxed standing position, the tape will be applied bilaterally starting from the&#xD;
      first to the last thoracic vertebra. then, a second tape will be applied to the scapula while&#xD;
      it assumes a position of scapular depression and retraction. This tape will be applied&#xD;
      bilaterally and extended from the midpoint of the spine of the scapula to the last thoracic&#xD;
      vertebra. This taping was applied for 12 weeks and changes every 2 days (3times per week) In&#xD;
      addition to the rigid tape, a standard physical therapy protocol will be introduced. This&#xD;
      standard protocol will consist of progressive strengthening exercises for rotator cuff&#xD;
      muscles. The resistance will be applied first by a red-colored elastic Thera-band. Then&#xD;
      progressed, using the green-colored band. Each exercise will be performed 10 times /session,&#xD;
      Self-stretching exercises for levator scapula, posterior deltoid, pectoralis minor, and&#xD;
      latissimus dorsi muscles. Five repetitions of stretching will be performed for each muscle&#xD;
      per session In addition to the standard protocol, the SSE group will receive scapular&#xD;
      stabilizing exercises in the form of wall slides with squat, Wall push-ups with ipsilateral&#xD;
      leg extension, lawnmower with diagonal squat, resisted retraction to scapula with opposite&#xD;
      leg squat robbery with squat. ten repetitions / exercises/ session were performed .&#xD;
&#xD;
      The CG will receive the standard protocol only Statistical analysis: SPSS (Version 16) for&#xD;
      Windows will be used to analyze the obtained data. Mean± SD and percentage of differences&#xD;
      will be calculated.&#xD;
&#xD;
      the current study tends to compare the effect of two different treatment techniques used in&#xD;
      the rehabilitation of SIS. Rigid tapping and scapular stabilizing exercises will be applied&#xD;
      then the level of function, and pain intensity will be measured before and after the&#xD;
      intervention and at 3 months follow-up.&#xD;
&#xD;
      Detailed Description: Patients will be recruited through a verbal and written announcement&#xD;
      from the customers of a local out-patient clinic. the appropriate sample size of patients&#xD;
      diagnosed with SIS who will meet the inclusion criteria will join the study after signing the&#xD;
      consent form.&#xD;
&#xD;
      patients will be assigned randomly into three equal groups using permuted blocks. The first&#xD;
      group (RTG) received rigid taping plus a standard physical therapy protocol. The second group&#xD;
      (SSEG) received scapular stabilizing exercises plus the same standard protocol, and the third&#xD;
      group (control group) received the standard protocol only The inclusion criteria were:&#xD;
      positive 4 out of the clinical signs: empty can test, Hawkins sign, Neer' sign, tenderness&#xD;
      upon palpation of the greater tuberosity of the humerus, and painful movement between 60°_&#xD;
      and 120°(painful arc) Subjects will be excluded if they have a previous history of shoulder&#xD;
      surgery, cervical spine involvement, upper-limb fracture, adhesive capsulitis, joint&#xD;
      instability, intraarticular corticosteroids injections within the last 2 months During the&#xD;
      first interview, all subjects will be checked for inclusion criteria. Eligible subjects will&#xD;
      be assessed for pain level using a validated version of the Visual Analog Scale (VAS).&#xD;
      Moreover, the functional level of the shoulder will be assessed using shoulder pain and&#xD;
      disability index (SPADI). It is a valid and reliable scale with a score ranging from 0&#xD;
      (normal) to 100 (complete disability). Pain and functional level were assessed again after&#xD;
      the end of the treatment period and after 3months (following up) 12 weeks-rehabilitation&#xD;
      program will be implemented for all participants with a frequency of 3 sessions/week. The RT&#xD;
      group will receive a bilateral rigid taping technique using zinc oxide tape and along with&#xD;
      the protective tape. With the participant assuming a relaxed standing position, the tape will&#xD;
      be applied bilaterally starting from the first to the last thoracic vertebra. then, a second&#xD;
      tape will be applied to the scapulae while it assumes a position of scapular depression and&#xD;
      retraction. This tape will be applied bilaterally and extended from the midpoint of the spine&#xD;
      of the scapula to the last thoracic vertebra. This taping will be applied for 12 weeks and&#xD;
      will be changed every 2 days (3times per week) In addition to the rigid tape, a standard&#xD;
      physical therapy protocol will be conducted. This protocol will consist of progressive&#xD;
      strengthening exercises for rotator cuff muscles. The resistance was applied first by a&#xD;
      red-colored elastic Thera-band. Then progressed, using the green-colored band. Each exercise&#xD;
      will be performed 10 times /session,( Self-stretching exercises for levator scapula,&#xD;
      posterior deltoid, pectoralis minor, and latissimus dorsi muscles. Five repetitions of&#xD;
      stretching will be performed for each muscle per session In addition to the standard&#xD;
      protocol, the SSE group will receive scapular stabilizing exercises in the form of wall&#xD;
      slides with squat, Wall push-ups with ipsilateral leg extension, lawnmower with diagonal&#xD;
      squat, resisted retraction to scapula with opposite leg squat robbery with squat. ten&#xD;
      repetitions / exercises/ session were performed .&#xD;
&#xD;
      The CG will receive the standard protocol only Statistical analysis: SPSS (Version 16) for&#xD;
      Windows will be used to analyze the obtained data. Mean± SD and percentage of differences&#xD;
      will be calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2021</start_date>
  <completion_date type="Actual">September 20, 2021</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</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>double-blind randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>the process of allocation will be concealed using non transparent envelops that contain a code number. these codes indicated one of the three groups. the interpretation of these codes will be with an author who will not be involved in assessment or treatment procedures. At the day of the first intervention session, the code interpretation will be available</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>Change from Baseline Shoulder pain and function at 3 months&quot;</time_frame>
    <description>The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain (visual analouge scale)</measure>
    <time_frame>Change from Baseline Shoulder pain at 3 months&quot;</time_frame>
    <description>scale with a score ranging from 0 (normal) to 100 (complete disability</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Impingement Syndrome of Ankle</condition>
  <arm_group>
    <arm_group_label>rigid tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the rigid tapping technique using zinc oxide tape and protective tape (reference). With the participant assuming a relaxed standing position, the tape was applied bilaterally starting from the first to the last thoracic vertebra. A second tape was then applied to form a position of scapular depression and retraction. This tape was applied bilaterally and extended from the midpoint of the spine of the scapula to the last thoracic vertebra (figure ). This taping was applied for 12 weeks and changes every 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>scapular stabilizing exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>scapular stabilizing exercises in the form of (1)wall slides with squat, (2) Wall push-ups with ipsilateral leg extension, (3) lawnmower with diagonal squat, (4) resisted retraction to scapula with opposite leg squat (5) robbery with squat. ten repetitions / exercises/ session were perform</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>a standard physical therapy protocol will be introduced. This protocol consisted of (1) progressive strengthening exercises for rotator cuff muscles. The resistance was applied first by a red-colored elastic Thera-band. Then progressed, using the green-colored band. Each exercise was performed 10 times /session, (2) Self-stretching exercises for levator scapula, posterior deltoid, pectoralis minor, and latissimus dorsi muscles. Five repetitions of stretching were performed for each muscle per session</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>rigid tapping</intervention_name>
    <description>Taping techniques We will use rigid tape and apply it bilaterally. In the rigid tape application, a combination pack of zinc oxide tape and the protective tape will be used. The protective tape will be applied first with no tension. To apply the rigid tape, subjects will be instructed to place their thoracic spine in a neutral position, the rigid tape will be applied bilaterally from the first to the twelfth thoracic vertebra. Subjects will be asked to retract and depress the scapula. The rigid tape will be applied diagonally from the middle of the scapular spine to the twelfth thoracic vertebra; this technique will be applied bilaterally. The rigid tape will be applied 3 times per week and will be applied for 6 weeks.</description>
    <arm_group_label>rigid tape</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>scapular stabilizing excercise</intervention_name>
    <description>consisted of:&#xD;
wall slides with squat,&#xD;
wall push-ups plus ipsilateral leg extension,&#xD;
lawnmower with diagonal squat,&#xD;
resisted scapular retraction with contralateral leg squat and robbery with squat.&#xD;
Robbery with squat&#xD;
Resisted shoulder internal rotation with step&#xD;
Resisted shoulder external rotation with step&#xD;
Resisted full can with step All resisted exercises were performed with elastic bands with red color-coded resistance levels and progressed through green and blue bands The patient will perform 10 repetitions 3 sets to 15 repetitions 3 sets and 20 repetitions 3 sets weekly.</description>
    <arm_group_label>scapular stabilizing exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>therapeutic exercises</intervention_name>
    <description>Pectoralis minor stretching&#xD;
Posterior shoulder stretching&#xD;
Levator scapula stretching&#xD;
Latissimus dorsi stretching ( stretching exercises will be 5 repetitions each session - 3 times per week)&#xD;
Resisted shoulder internal rotation&#xD;
Resisted shoulder external rotation&#xD;
Resisted full can (strengthening exercises will be 510 repetitions each session - 3 times per week) All resisted exercises were performed with elastic bands with red color-coded resistance levels and progressed through green and blue bands NOTE. All resisted exercises were progressed from starting 10 repetitions 3 sets to 15 repetitions 3 sets and 20 repetitions 3 sets weekly, supervising movement quality, presence of pain, and fatigue. If the subject achieves 20 repetitions 3 successfully, heavier resistance with resistance band color-coded loading prescribed from 10 repetitions 3 sets.</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>rigid tape</arm_group_label>
    <arm_group_label>scapular stabilizing exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects having positive results to at least 4 of the following tests:&#xD;
&#xD;
          1. Neer impingement sign&#xD;
&#xD;
          2. Hawkins sign&#xD;
&#xD;
          3. pain during supraspinatus empty can test&#xD;
&#xD;
          4. the painful arc between 60⁰_ and 120⁰&#xD;
&#xD;
          5. tenderness when palpating the greater tuberosity of the humerus -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded if they have;&#xD;
&#xD;
          -  cervical spine involvement;&#xD;
&#xD;
          -  the presence of a glenohumeral joint adhesive capsulitis, or instability;&#xD;
&#xD;
          -  a history of previous shoulder surgery;&#xD;
&#xD;
          -  upper-limb fracture;&#xD;
&#xD;
          -  had systemic illnesses,&#xD;
&#xD;
          -  receiving another physiotherapy treatment of this disorder in the past 6 weeks; or&#xD;
&#xD;
          -  receiving steroid injection into or around the shoulder in the past 2 months.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ibrahim M dewir, Assist .prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>physical therapy dep, College of Applied Medical Sciences, Taif University, S.A</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Hail</name>
      <address>
        <city>Ha'il</city>
        <state>Hail</state>
        <zip>81451</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>Buttagat V, Taepa N, Suwannived N, Rattanachan N. Effects of scapular stabilization exercise on pain related parameters in patients with scapulocostal syndrome: A randomized controlled trial. J Bodyw Mov Ther. 2016 Jan;20(1):115-122. doi: 10.1016/j.jbmt.2015.07.036. Epub 2015 Jul 26.</citation>
    <PMID>26891646</PMID>
  </reference>
  <reference>
    <citation>Cools AM, Witvrouw EE, Danneels LA, Cambier DC. Does taping influence electromyographic muscle activity in the scapular rotators in healthy shoulders? Man Ther. 2002 Aug;7(3):154-62. doi: 10.1054/math.2002.0464.</citation>
    <PMID>12372312</PMID>
  </reference>
  <reference>
    <citation>De Mey K, Danneels L, Cagnie B, Van den Bosch L, Flier J, Cools AM. Kinetic chain influences on upper and lower trapezius muscle activation during eight variations of a scapular retraction exercise in overhead athletes. J Sci Med Sport. 2013 Jan;16(1):65-70. doi: 10.1016/j.jsams.2012.04.008. Epub 2012 May 31.</citation>
    <PMID>22658589</PMID>
  </reference>
  <reference>
    <citation>Green S, Buchbinder R, Glazier R, Forbes A. Systematic review of randomised controlled trials of interventions for painful shoulder: selection criteria, outcome assessment, and efficacy. BMJ. 1998 Jan 31;316(7128):354-60. doi: 10.1136/bmj.316.7128.354.</citation>
    <PMID>9487172</PMID>
  </reference>
  <reference>
    <citation>Hebert LJ, Moffet H, McFadyen BJ, Dionne CE. Scapular behavior in shoulder impingement syndrome. Arch Phys Med Rehabil. 2002 Jan;83(1):60-9. doi: 10.1053/apmr.2002.27471.</citation>
    <PMID>11782834</PMID>
  </reference>
  <reference>
    <citation>Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.</citation>
    <PMID>12804509</PMID>
  </reference>
  <reference>
    <citation>Kalter J, Apeldoorn AT, Ostelo RW, Henschke N, Knol DL, van Tulder MW. Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial. BMC Musculoskelet Disord. 2011 Aug 17;12:188. doi: 10.1186/1471-2474-12-188.</citation>
    <PMID>21849055</PMID>
  </reference>
  <reference>
    <citation>Kamkar A, Irrgang JJ, Whitney SL. Nonoperative management of secondary shoulder impingement syndrome. J Orthop Sports Phys Ther. 1993 May;17(5):212-24. doi: 10.2519/jospt.1993.17.5.212.</citation>
    <PMID>8343779</PMID>
  </reference>
  <reference>
    <citation>Kaya E, Zinnuroglu M, Tugcu I. Kinesio taping compared to physical therapy modalities for the treatment of shoulder impingement syndrome. Clin Rheumatol. 2011 Feb;30(2):201-7. doi: 10.1007/s10067-010-1475-6. Epub 2010 Apr 30.</citation>
    <PMID>20443039</PMID>
  </reference>
  <reference>
    <citation>Kibler WB, McMullen J, Uhl T. Shoulder rehabilitation strategies, guidelines, and practice. Orthop Clin North Am. 2001 Jul;32(3):527-38. doi: 10.1016/s0030-5898(05)70222-4.</citation>
    <PMID>11888148</PMID>
  </reference>
  <reference>
    <citation>Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. doi: 10.1016/j.jse.2008.06.004. Epub 2008 Oct 2.</citation>
    <PMID>18835532</PMID>
  </reference>
  <reference>
    <citation>Lewis JS, Wright C, Green A. Subacromial impingement syndrome: the effect of changing posture on shoulder range of movement. J Orthop Sports Phys Ther. 2005 Feb;35(2):72-87. doi: 10.2519/jospt.2005.35.2.72.</citation>
    <PMID>15773565</PMID>
  </reference>
  <reference>
    <citation>Ludewig PM, Cook TM. Alterations in shoulder kinematics and associated muscle activity in people with symptoms of shoulder impingement. Phys Ther. 2000 Mar;80(3):276-91.</citation>
    <PMID>10696154</PMID>
  </reference>
  <reference>
    <citation>Ludewig PM, Reynolds JF. The association of scapular kinematics and glenohumeral joint pathologies. J Orthop Sports Phys Ther. 2009 Feb;39(2):90-104. doi: 10.2519/jospt.2009.2808.</citation>
    <PMID>19194022</PMID>
  </reference>
  <reference>
    <citation>McClure P, Greenberg E, Kareha S. Evaluation and management of scapular dysfunction. Sports Med Arthrosc Rev. 2012 Mar;20(1):39-48. doi: 10.1097/JSA.0b013e31824716a8.</citation>
    <PMID>22311292</PMID>
  </reference>
  <reference>
    <citation>McClure PW, Bialker J, Neff N, Williams G, Karduna A. Shoulder function and 3-dimensional kinematics in people with shoulder impingement syndrome before and after a 6-week exercise program. Phys Ther. 2004 Sep;84(9):832-48.</citation>
    <PMID>15330696</PMID>
  </reference>
  <reference>
    <citation>Miller P, Osmotherly P. Does scapula taping facilitate recovery for shoulder impingement symptoms? A pilot randomized controlled trial. J Man Manip Ther. 2009;17(1):E6-E13. doi: 10.1179/jmt.2009.17.1.6E.</citation>
    <PMID>20046559</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Hail</investigator_affiliation>
    <investigator_full_name>Hisham Mohamed Hussein</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Impingement Syndrome- rigid tape-scapular stabilizing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Impingement Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>this is the policy of the laboratory where the practical part will be conducted</ipd_description>
  </patient_data>
  <!-- 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/NCT04468594
org study id: 1234567890
nct id: NCT04468594
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the current study tends to compare the effect of two different treatment techniques used in
      the rehabilitation of shoulder impingement syndrome. rigid tapping and scapular stabilizing
      exercises will be applied and the level of function and pain intensity will be measured
      before and after the intervention and at 3 months follow up. while both methods of treatment
      used previously, the comparison between their effects is not yet investigated and no data is
      available regarding the superiority of one over the other.
Patients will be recruited through a verbal and written announcement from the customers of a
      local out-patient clinic. The appropriate number of patients, diagnosed with SIS, who will
      meet the inclusion criteria and accept to sign a consent form will join the study.

      patients will be assigned randomly into three equal groups using permuted blocks of variable
      sizes. The first group rigid tape (RT) group will receive rigid taping plus a standard
      physical therapy protocol. The second group scapular stabilizing exercises (SSE) group will
      receive scapular stabilizing exercises plus the same standard protocol, and the third group
      (control group) will receive the standard protocol only.

      The inclusion criteria were: positive 4 out of the following clinical signs: empty can test,
      Hawkins sign, Neer' sign, tenderness upon palpation of the greater tuberosity of the humerus,
      and painful movement between 60°_ and 120°(painful arc) Patients will be excluded if they
      demonstrate a previous history of shoulder surgery, cervical spine involvement, upper-limb
      fracture, adhesive capsulitis, joint instability, intraarticular corticosteroids injections
      within the last 2 months During the first interview, all patients will be checked for
      inclusion criteria. then undergo baseline assessment for pain level using a validated version
      of the Visual Analog Scale (VAS). Moreover, the functional level of the shoulder will be
      assessed using shoulder pain and disability index (SPADI). SPADI is a valid and reliable
      scale. it has a score ranging from 0 (normal) to 100 (complete disability). Pain and
      functional level will be assessed again after the end of the treatment period and after 3
      months (following up) 12 weeks-rehabilitation program will be implemented for all patients
      with a frequency of 3 sessions/week. The RT group will receive a bilateral rigid taping
      technique using zinc oxide tape and along with the protective tape. With the participant
      assuming a relaxed standing position, the tape will be applied bilaterally starting from the
      first to the last thoracic vertebra. then, a second tape will be applied to the scapula while
      it assumes a position of scapular depression and retraction. This tape will be applied
      bilaterally and extended from the midpoint of the spine of the scapula to the last thoracic
      vertebra. This taping was applied for 12 weeks and changes every 2 days (3times per week) In
      addition to the rigid tape, a standard physical therapy protocol will be introduced. This
      standard protocol will consist of progressive strengthening exercises for rotator cuff
      muscles. The resistance will be applied first by a red-colored elastic Thera-band. Then
      progressed, using the green-colored band. Each exercise will be performed 10 times /session,
      Self-stretching exercises for levator scapula, posterior deltoid, pectoralis minor, and
      latissimus dorsi muscles. Five repetitions of stretching will be performed for each muscle
      per session In addition to the standard protocol, the SSE group will receive scapular
      stabilizing exercises in the form of wall slides with squat, Wall push-ups with ipsilateral
      leg extension, lawnmower with diagonal squat, resisted retraction to scapula with opposite
      leg squat robbery with squat. ten repetitions / exercises/ session were performed .

      The CG will receive the standard protocol only Statistical analysis: SPSS (Version 16) for
      Windows will be used to analyze the obtained data. Mean± SD and percentage of differences
      will be calculated.

      the current study tends to compare the effect of two different treatment techniques used in
      the rehabilitation of SIS. Rigid tapping and scapular stabilizing exercises will be applied
      then the level of function, and pain intensity will be measured before and after the
      intervention and at 3 months follow-up.

      Detailed Description: Patients will be recruited through a verbal and written announcement
      from the customers of a local out-patient clinic. the appropriate sample size of patients
      diagnosed with SIS who will meet the inclusion criteria will join the study after signing the
      consent form.

      patients will be assigned randomly into three equal groups using permuted blocks. The first
      group (RTG) received rigid taping plus a standard physical therapy protocol. The second group
      (SSEG) received scapular stabilizing exercises plus the same standard protocol, and the third
      group (control group) received the standard protocol only The inclusion criteria were:
      positive 4 out of the clinical signs: empty can test, Hawkins sign, Neer' sign, tenderness
      upon palpation of the greater tuberosity of the humerus, and painful movement between 60°_
      and 120°(painful arc) Subjects will be excluded if they have a previous history of shoulder
      surgery, cervical spine involvement, upper-limb fracture, adhesive capsulitis, joint
      instability, intraarticular corticosteroids injections within the last 2 months During the
      first interview, all subjects will be checked for inclusion criteria. Eligible subjects will
      be assessed for pain level using a validated version of the Visual Analog Scale (VAS).
      Moreover, the functional level of the shoulder will be assessed using shoulder pain and
      disability index (SPADI). It is a valid and reliable scale with a score ranging from 0
      (normal) to 100 (complete disability). Pain and functional level were assessed again after
      the end of the treatment period and after 3months (following up) 12 weeks-rehabilitation
      program will be implemented for all participants with a frequency of 3 sessions/week. The RT
      group will receive a bilateral rigid taping technique using zinc oxide tape and along with
      the protective tape. With the participant assuming a relaxed standing position, the tape will
      be applied bilaterally starting from the first to the last thoracic vertebra. then, a second
      tape will be applied to the scapulae while it assumes a position of scapular depression and
      retraction. This tape will be applied bilaterally and extended from the midpoint of the spine
      of the scapula to the last thoracic vertebra. This taping will be applied for 12 weeks and
      will be changed every 2 days (3times per week) In addition to the rigid tape, a standard
      physical therapy protocol will be conducted. This protocol will consist of progressive
      strengthening exercises for rotator cuff muscles. The resistance was applied first by a
      red-colored elastic Thera-band. Then progressed, using the green-colored band. Each exercise
      will be performed 10 times /session,( Self-stretching exercises for levator scapula,
      posterior deltoid, pectoralis minor, and latissimus dorsi muscles. Five repetitions of
      stretching will be performed for each muscle per session In addition to the standard
      protocol, the SSE group will receive scapular stabilizing exercises in the form of wall
      slides with squat, Wall push-ups with ipsilateral leg extension, lawnmower with diagonal
      squat, resisted retraction to scapula with opposite leg squat robbery with squat. ten
      repetitions / exercises/ session were performed .

      The CG will receive the standard protocol only Statistical analysis: SPSS (Version 16) for
      Windows will be used to analyze the obtained data. Mean± SD and percentage of differences
      will be calculated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double-blind randomized controlled trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: the process of allocation will be concealed using non transparent envelops that contain a code number. these codes indicated one of the three groups. the interpretation of these codes will be with an author who will not be involved in assessment or treatment procedures. At the day of the first intervention session, the code interpretation will be available
measure: The Shoulder Pain and Disability Index (SPADI)
time frame: Change from Baseline Shoulder pain and function at 3 months"
description: The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
measure: pain (visual analouge scale)
time frame: Change from Baseline Shoulder pain at 3 months"
description: scale with a score ranging from 0 (normal) to 100 (complete disability
arm group label: rigid tape
arm group type: Experimental
description: the rigid tapping technique using zinc oxide tape and protective tape (reference). With the participant assuming a relaxed standing position, the tape was applied bilaterally starting from the first to the last thoracic vertebra. A second tape was then applied to form a position of scapular depression and retraction. This tape was applied bilaterally and extended from the midpoint of the spine of the scapula to the last thoracic vertebra (figure ). This taping was applied for 12 weeks and changes every 3 days
arm group label: scapular stabilizing exercises
arm group type: Experimental
description: scapular stabilizing exercises in the form of (1)wall slides with squat, (2) Wall push-ups with ipsilateral leg extension, (3) lawnmower with diagonal squat, (4) resisted retraction to scapula with opposite leg squat (5) robbery with squat. ten repetitions / exercises/ session were perform
arm group label: control
arm group type: Active Comparator
description: a standard physical therapy protocol will be introduced. This protocol consisted of (1) progressive strengthening exercises for rotator cuff muscles. The resistance was applied first by a red-colored elastic Thera-band. Then progressed, using the green-colored band. Each exercise was performed 10 times /session, (2) Self-stretching exercises for levator scapula, posterior deltoid, pectoralis minor, and latissimus dorsi muscles. Five repetitions of stretching were performed for each muscle per session
intervention type: Other
intervention name: rigid tapping
description: Taping techniques We will use rigid tape and apply it bilaterally. In the rigid tape application, a combination pack of zinc oxide tape and the protective tape will be used. The protective tape will be applied first with no tension. To apply the rigid tape, subjects will be instructed to place their thoracic spine in a neutral position, the rigid tape will be applied bilaterally from the first to the twelfth thoracic vertebra. Subjects will be asked to retract and depress the scapula. The rigid tape will be applied diagonally from the middle of the scapular spine to the twelfth thoracic vertebra; this technique will be applied bilaterally. The rigid tape will be applied 3 times per week and will be applied for 6 weeks.
arm group label: rigid tape
intervention type: Other
intervention name: scapular stabilizing excercise
description: consisted of:
wall slides with squat,
wall push-ups plus ipsilateral leg extension,
lawnmower with diagonal squat,
resisted scapular retraction with contralateral leg squat and robbery with squat.
Robbery with squat
Resisted shoulder internal rotation with step
Resisted shoulder external rotation with step
Resisted full can with step All resisted exercises were performed with elastic bands with red color-coded resistance levels and progressed through green and blue bands The patient will perform 10 repetitions 3 sets to 15 repetitions 3 sets and 20 repetitions 3 sets weekly.
arm group label: scapular stabilizing exercises
intervention type: Other
intervention name: therapeutic exercises
description: Pectoralis minor stretching
Posterior shoulder stretching
Levator scapula stretching
Latissimus dorsi stretching ( stretching exercises will be 5 repetitions each session - 3 times per week)
Resisted shoulder internal rotation
Resisted shoulder external rotation
Resisted full can (strengthening exercises will be 510 repetitions each session - 3 times per week) All resisted exercises were performed with elastic bands with red color-coded resistance levels and progressed through green and blue bands NOTE. All resisted exercises were progressed from starting 10 repetitions 3 sets to 15 repetitions 3 sets and 20 repetitions 3 sets weekly, supervising movement quality, presence of pain, and fatigue. If the subject achieves 20 repetitions 3 successfully, heavier resistance with resistance band color-coded loading prescribed from 10 repetitions 3 sets.
arm group label: control
arm group label: rigid tape
arm group label: scapular stabilizing exercises
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ibrahim M dewir, Assist .prof
role: Principal Investigator
affiliation: physical therapy dep, College of Applied Medical Sciences, Taif University, S.A
facility: 
country: Saudi Arabia
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responsible party type: Principal Investigator
investigator affiliation: University of Hail
investigator full name: Hisham Mohamed Hussein
investigator title: Assistant Professor
mesh term: Shoulder Impingement Syndrome
mesh term: Syndrome
mesh term: Rotator Cuff Injuries
sharing ipd: No
ipd description: this is the policy of the laboratory where the practical part will be conducted