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/NCT06010264</url>
    </required_header>
    <id_info>
      <org_study_id>2022-14/123</org_study_id>
      <nct_id>NCT06010264</nct_id>
    </id_info>
    <brief_title>THE EFFECTS OF EARLY PERIOD KINESIOTAPE</brief_title>
    <official_title>THE EFFECTS OF EARLY PERIOD KINESIO TAPE ON CLINICAL OUTCOMES IN PATIENTS WITH ARTROSCOPIC ROTATOR CUFF REPAIR</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kirsehir Ahi Evran Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kirsehir Ahi Evran Universitesi</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 goal of this clinical trial is to the effects of kinesio tape application on pain, edema,&#xD;
        range of motion and functionality .&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does kinesiotape application reduce pain and edema and improve quality of life in the&#xD;
             early period in individuals undergoing arthroscopic rotator cuff repair?&#xD;
  &#xD;
          -  Does kinesiotape application provide early restoration of functional activity level in&#xD;
             individuals undergoing arthroscopic rotator cuff repair?&#xD;
  &#xD;
        Participants will receive kinesiotaping in addition to traditional physiotherapy programs.&#xD;
  &#xD;
        If there is a comparison group: Researchers will compare kinesiotape group, shamtape group&#xD;
        and control group to see if kinesiotaping.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic shoulder pain is the second most common musculoskeletal problem in the population&#xD;
        with a prevalence ranging from 15% to 22%. Rotator cuff (RM) tears are one of the important&#xD;
        pathophysiologic conditions leading to shoulder pain. Early treatment of RM tears is&#xD;
        conservative and includes oral analgesics, non-steroidal anti-inflammatory drugs,&#xD;
        corticosteroid injections if necessary and physiotherapy methods. Treatment of rotator sheath&#xD;
        problems may be surgical and/or conservative depending on the indications. Surgical treatment&#xD;
        is inevitable for partial tears and complete ruptures that do not respond to conservative&#xD;
        treatment. After surgery, a good rehabilitation program is needed to increase the success of&#xD;
        the surgical intervention, return to functional activities and improve the patient's quality&#xD;
        of life. One of the most important problems for the patient, physician and physiotherapist in&#xD;
        the rehabilitation program to be applied in this period is the immobilization period of 6&#xD;
        weeks. This is the recommended time for tissue healing. However, the negative effects of&#xD;
        prolonged immobilization should not be forgotten. It is important to use early physiotherapy&#xD;
        applications to prevent adhesions and reduce complications that may occur.&#xD;
  &#xD;
        The Kinesio Taping® technique and Kinesio Tex® tape were developed in 1973 by Dr. Kenzo Kase,&#xD;
        a Japanese chiropractor and acupuncturist. There is an increasing number of health&#xD;
        professionals, including physicians and physiotherapists who deal with musculoskeletal&#xD;
        diseases and lymphology, who apply this method to their patients all over the world. It is&#xD;
        also widely used in the sports world, especially considering its ease of use and effects. It&#xD;
        helps structures such as the musculoskeletal system, circulatory system and nervous system to&#xD;
        return to normal function. It is a preferred method because these bands are easy to apply and&#xD;
        patients can easily remove them. In the literature, there is no study examining the effects&#xD;
        of kinesio tape application after rotator cuff repair.&#xD;
  &#xD;
        Considering the effects of kinesio tape on pain and edema; we think that it will have&#xD;
        positive results in the rehabilitation program applied after rotator cuff repair.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 6, 2022</start_date>
    <completion_date type="Actual">January 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 29, 2022</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>Randomized</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain severity</measure>
      <time_frame>7 weeks</time_frame>
      <description>Visual Analogue Scale (0-10, higher means worse)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Edema</measure>
      <time_frame>7 weeks</time_frame>
      <description>Diameter measurement was performed to evaluate the level of edema in the shoulder joint. Two reference points, the posterosuperior end of the acromion and the korkoid process, were used to measure the diameter of the shoulder. First, the distance between these points on the upper border of the deltoid muscle was measured with a tape measure and recorded. The second measurement was taken 1 cm lateral to the first measurement, over the middle deltoid and recorded.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Modified Constant-Murley score</measure>
      <time_frame>7 weeks</time_frame>
      <description>The Modified Constant-Murley score is a 100-point scoring system that is divided into 4 subscales: pain, 15 points; activities of daily living (ADL), 20; range of motion (ROM), 40; and strength, 25. The pain and ADL subscales are self-reported by the patient. In the original version, the pain score was graded as none = 15, mild = 10, moderate = 5, and severe = 0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>REVISED OXFORD SHOULDER SCORE</measure>
      <time_frame>7 weeks</time_frame>
      <description>REVISED OXFORD SHOULDER SCORE was developed to evaluate the functional parameters of the shoulder after surgery. It consists of a total of 12 questions. Each question has 5 answers ranging from 0 (bad score) to 4 (good score). The total score ranges from 0 to 48. 0 indicates the worst result, while the higher the score, the better the functionality. A score between 0-19 indicates severe disability, 20-29 indicates moderate disability, 30-39 indicates mild disability. A score between 40-48 indicates adequate functionality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SHOULDER PAIN AND DISABILITY INDEX</measure>
      <time_frame>7 weeks</time_frame>
      <description>The SPADI is a 13 item self-reported questionnaire assessing pain and functional status. Each item is measured on a 0-10 scale and a 0-100 score calculated. Higher scores represent greater levels of pain and disability. The SPADI has been shown to have good test-re-test reliability and be sensitive to change.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario Rotator Cuff Index</measure>
      <time_frame>7 weeks</time_frame>
      <description>WORC consists of 5 sections with 21 questions. The answer to each question is given on the VAS. The final score is between 0 and 2100. The higher the score, the lower the quality of life.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">45</enrollment>
    <condition>Rotator Cuff Injuries</condition>
    <condition>Rotator Cuff Tears</condition>
    <arm_group>
      <arm_group_label>Kinesiotaping group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Kinesiotaping + Standard Physiotherapy Program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard Physiotherapy Program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Shamtape Group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Shamtaping + Standard Physiotherapy Program</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Kinesiotape</intervention_name>
      <description>In the kinesiotaping group, kinesiotape was applied from the first postoperative day in addition to conservative treatment.&#xD;
  Kinesiobant application was performed regularly until the 6th week by a researcher with a certificate in kinesiobanting in accordance with the lymphatic correction and pain inhibition techniques described by Kenzo Kase.&#xD;
  Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain</description>
      <arm_group_label>Kinesiotaping group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Shamtape</intervention_name>
      <description>In the sham taping group, sham tape was applied from the first postoperative day in addition to conservative treatment. Medical flasters were used as sham tape. Sham tapes were applied by cutting in the same fan shape as in kinesioband.&#xD;
  Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain</description>
      <arm_group_label>Shamtape Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard Physiotherapy Program</intervention_name>
      <description>Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be between the ages of 18-65,&#xD;
  &#xD;
            -  Arthroscopic rotator cuff repair as a surgical method,&#xD;
  &#xD;
            -  diagnosis of a small or medium-sized (&lt;3 cm) rotator cuff tear by magnetic resonance&#xD;
               imaging,&#xD;
  &#xD;
            -  Having a score above 24 on the Mini Mental State Examination,&#xD;
  &#xD;
            -  Volunteering to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of diabetes mellitus,&#xD;
  &#xD;
            -  Stage three and above according to the Goutallier fatty degeneration classification,&#xD;
  &#xD;
            -  Presence of a neurological problem,&#xD;
  &#xD;
            -  Presence of cervical disc herniation,&#xD;
  &#xD;
            -  Past history of orthopedic disease on the affected side,&#xD;
  &#xD;
            -  Presence of osteoarthritis, rheumatoid arthritis or other systemic inflammatory&#xD;
               problem,&#xD;
  &#xD;
            -  Corticosteroid injection for the affected side within 6 weeks before diagnosis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Kırsehir Ahi Evran Universty</name>
        <address>
          <city>Kırşehir</city>
          <zip>40100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Reynard F, Vuistiner P, Leger B, Konzelmann M. Immediate and short-term effects of kinesiotaping on muscular activity, mobility, strength and pain after rotator cuff surgery: a crossover clinical trial. BMC Musculoskelet Disord. 2018 Aug 22;19(1):305. doi: 10.1186/s12891-018-2169-5.</citation>
      <PMID>30134883</PMID>
    </results_reference>
    <results_reference>
      <citation>Gulenc B, Yalcin S, Genc SG, Bicer H, Erdil M. Is Kinesiotherapy Effective in Relieving Pain and Reducing Swelling after Shoulder Arthroscopy? Acta Chir Orthop Traumatol Cech. 2019;86(3):216-219.</citation>
      <PMID>31333187</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kirsehir Ahi Evran Universitesi</investigator_affiliation>
      <investigator_full_name>Muhammed İhsan KODAK</investigator_full_name>
      <investigator_title>PHD / LECTURER</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rotator Cuff Injuries</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/NCT06010264
  org study id: 2022-14/123
  nct id: NCT06010264
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to the effects of kinesio tape application on pain, edema,
        range of motion and functionality .
  
        The main questions it aims to answer are:
  
          -  Does kinesiotape application reduce pain and edema and improve quality of life in the
             early period in individuals undergoing arthroscopic rotator cuff repair?
  
          -  Does kinesiotape application provide early restoration of functional activity level in
             individuals undergoing arthroscopic rotator cuff repair?
  
        Participants will receive kinesiotaping in addition to traditional physiotherapy programs.
  
        If there is a comparison group: Researchers will compare kinesiotape group, shamtape group
        and control group to see if kinesiotaping.
  Chronic shoulder pain is the second most common musculoskeletal problem in the population
        with a prevalence ranging from 15% to 22%. Rotator cuff (RM) tears are one of the important
        pathophysiologic conditions leading to shoulder pain. Early treatment of RM tears is
        conservative and includes oral analgesics, non-steroidal anti-inflammatory drugs,
        corticosteroid injections if necessary and physiotherapy methods. Treatment of rotator sheath
        problems may be surgical and/or conservative depending on the indications. Surgical treatment
        is inevitable for partial tears and complete ruptures that do not respond to conservative
        treatment. After surgery, a good rehabilitation program is needed to increase the success of
        the surgical intervention, return to functional activities and improve the patient's quality
        of life. One of the most important problems for the patient, physician and physiotherapist in
        the rehabilitation program to be applied in this period is the immobilization period of 6
        weeks. This is the recommended time for tissue healing. However, the negative effects of
        prolonged immobilization should not be forgotten. It is important to use early physiotherapy
        applications to prevent adhesions and reduce complications that may occur.
  
        The Kinesio Taping® technique and Kinesio Tex® tape were developed in 1973 by Dr. Kenzo Kase,
        a Japanese chiropractor and acupuncturist. There is an increasing number of health
        professionals, including physicians and physiotherapists who deal with musculoskeletal
        diseases and lymphology, who apply this method to their patients all over the world. It is
        also widely used in the sports world, especially considering its ease of use and effects. It
        helps structures such as the musculoskeletal system, circulatory system and nervous system to
        return to normal function. It is a preferred method because these bands are easy to apply and
        patients can easily remove them. In the literature, there is no study examining the effects
        of kinesio tape application after rotator cuff repair.
  
        Considering the effects of kinesio tape on pain and edema; we think that it will have
        positive results in the rehabilitation program applied after rotator cuff repair.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pain severity
  time frame: 7 weeks
  description: Visual Analogue Scale (0-10, higher means worse)
  measure: Edema
  time frame: 7 weeks
  description: Diameter measurement was performed to evaluate the level of edema in the shoulder joint. Two reference points, the posterosuperior end of the acromion and the korkoid process, were used to measure the diameter of the shoulder. First, the distance between these points on the upper border of the deltoid muscle was measured with a tape measure and recorded. The second measurement was taken 1 cm lateral to the first measurement, over the middle deltoid and recorded.
  measure: Modified Constant-Murley score
  time frame: 7 weeks
  description: The Modified Constant-Murley score is a 100-point scoring system that is divided into 4 subscales: pain, 15 points; activities of daily living (ADL), 20; range of motion (ROM), 40; and strength, 25. The pain and ADL subscales are self-reported by the patient. In the original version, the pain score was graded as none = 15, mild = 10, moderate = 5, and severe = 0.
  measure: REVISED OXFORD SHOULDER SCORE
  time frame: 7 weeks
  description: REVISED OXFORD SHOULDER SCORE was developed to evaluate the functional parameters of the shoulder after surgery. It consists of a total of 12 questions. Each question has 5 answers ranging from 0 (bad score) to 4 (good score). The total score ranges from 0 to 48. 0 indicates the worst result, while the higher the score, the better the functionality. A score between 0-19 indicates severe disability, 20-29 indicates moderate disability, 30-39 indicates mild disability. A score between 40-48 indicates adequate functionality.
  measure: SHOULDER PAIN AND DISABILITY INDEX
  time frame: 7 weeks
  description: The SPADI is a 13 item self-reported questionnaire assessing pain and functional status. Each item is measured on a 0-10 scale and a 0-100 score calculated. Higher scores represent greater levels of pain and disability. The SPADI has been shown to have good test-re-test reliability and be sensitive to change.
  measure: Western Ontario Rotator Cuff Index
  time frame: 7 weeks
  description: WORC consists of 5 sections with 21 questions. The answer to each question is given on the VAS. The final score is between 0 and 2100. The higher the score, the lower the quality of life.
  arm group label: Kinesiotaping group
  arm group type: Experimental
  description: Kinesiotaping + Standard Physiotherapy Program
  arm group label: Control group
  arm group type: Active Comparator
  description: Standard Physiotherapy Program
  arm group label: Shamtape Group
  arm group type: Sham Comparator
  description: Shamtaping + Standard Physiotherapy Program
  intervention type: Other
  intervention name: Kinesiotape
  description: In the kinesiotaping group, kinesiotape was applied from the first postoperative day in addition to conservative treatment.
  Kinesiobant application was performed regularly until the 6th week by a researcher with a certificate in kinesiobanting in accordance with the lymphatic correction and pain inhibition techniques described by Kenzo Kase.
  Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain
  arm group label: Kinesiotaping group
  intervention type: Other
  intervention name: Shamtape
  description: In the sham taping group, sham tape was applied from the first postoperative day in addition to conservative treatment. Medical flasters were used as sham tape. Sham tapes were applied by cutting in the same fan shape as in kinesioband.
  Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain
  arm group label: Shamtape Group
  intervention type: Other
  intervention name: Standard Physiotherapy Program
  description: Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  citation: Reynard F, Vuistiner P, Leger B, Konzelmann M. Immediate and short-term effects of kinesiotaping on muscular activity, mobility, strength and pain after rotator cuff surgery: a crossover clinical trial. BMC Musculoskelet Disord. 2018 Aug 22;19(1):305. doi: 10.1186/s12891-018-2169-5.
  PMID: 30134883
  citation: Gulenc B, Yalcin S, Genc SG, Bicer H, Erdil M. Is Kinesiotherapy Effective in Relieving Pain and Reducing Swelling after Shoulder Arthroscopy? Acta Chir Orthop Traumatol Cech. 2019;86(3):216-219.
  PMID: 31333187
  responsible party type: Principal Investigator
  investigator affiliation: Kirsehir Ahi Evran Universitesi
  investigator full name: Muhammed İhsan KODAK
  investigator title: PHD / LECTURER
  mesh term: Rotator Cuff Injuries
  sharing ipd: No