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/NCT05975801</url>
    </required_header>
    <id_info>
      <org_study_id>Medipol University Hospital</org_study_id>
      <secondary_id>Medipol University</secondary_id>
      <nct_id>NCT05975801</nct_id>
    </id_info>
    <brief_title>Dry Cupping Therapy on Rotator Cuff Injuries</brief_title>
    <official_title>Investigation of the Effectiveness of Dry Cupping Therapy on Rotator Cuff Injuries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medipol University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medipol University Hospital</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>
        Shoulder pain is the most common musculoskeletal problem after spine and knee complaints.&#xD;
        Rotator cuff injuries (RCI) are the most common cause of shoulder pain. RCI includes a wide&#xD;
        spectrum from subacromial impingement syndrome (SIS) to chronic tendinopathy, partial and&#xD;
        total ruptures of the rotator cuff. In recent years there has been a renewed interest in&#xD;
        traditional and complementary medicine (TCM) for various musculoskeletal problems. Cupping&#xD;
        therapy, which is one of the most commonly used TCM methods, is one of the oldest medical&#xD;
        applications with thousands of years of history. Although it is thought to be effective in&#xD;
        many diseases, there are not enough studies in the literature about its effectiveness and&#xD;
        mechanism of action. Our aim in this study is to investigate the effects of moving dry&#xD;
        cupping therapy on pain, range of motion (ROM), functionality and quality of life in RCI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Shoulder pain is the most common musculoskeletal problem after spine and knee complaints.&#xD;
        Rotator cuff injuries (RCI) are the most common cause of shoulder pain. RCI includes a wide&#xD;
        spectrum from subacromial impingement syndrome (SIS) to chronic tendinopathy, partial and&#xD;
        total ruptures of the rotator cuff. Conservative and surgical techniques are used in the&#xD;
        treatment. Conservative treatments; various medical treatments, activity modifications, hot&#xD;
        and cold agents, exercise, manual therapy, acupuncture, electrophysical agents, etc. includes&#xD;
        applications. In recent years there has been a renewed interest in traditional and&#xD;
        complementary medicine (TCM) for various musculoskeletal problems. Cupping therapy is an&#xD;
        ancient TCM treatment that has been practiced in different ways in many cultures in Asia,&#xD;
        Europe and the Middle East throughout history, but its true origin remains unclear. Although&#xD;
        cupping therapy has been used to treat pain and various complaints for thousands of years, it&#xD;
        has almost disappeared from the therapeutic spectrum of Western medicine with pharmacological&#xD;
        developments in the late 20th century. However, over the past few years, interest in the cup&#xD;
        has increased, and new clinical research suggests that the cup may be potentially effective&#xD;
        in the management of painful conditions, in the treatment of pain-related diseases. Although&#xD;
        it is stated in the literature that it is used in the treatment of many neuromusculoskeletal&#xD;
        problems, according to the information participants have obtained in the relevant literature,&#xD;
        there is not yet a study examining the effects of cupping therapy in RCI. In the light of&#xD;
        these data, our aim in this study is to investigate the effects of moving dry cupping therapy&#xD;
        on pain, range of motion (ROM), functionality and quality of life in RCI.Hypotheses:&#xD;
  &#xD;
        H0: Cupping therapy has no effect on improving pain, ROM, functionality and quality of life&#xD;
        in individuals with RCI.&#xD;
  &#xD;
        H1: Cupping therapy has an effect on improving pain, ROM, functionality and quality of life&#xD;
        in individuals with RCI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 2017</start_date>
    <completion_date type="Actual">January 2019</completion_date>
    <primary_completion_date type="Actual">May 2017</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 (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Shoulder pain</measure>
      <time_frame>1 months</time_frame>
      <description>Pain was evaluated with the Numerical Rating Scale (NRS). The patient was asked to mark his pain in numerical values ranging from 0 (no pain) to 10 (very severe pain). The higher the score obtained from this test, the more pain the patient has, and the smaller the score, the less the pain is predicted.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion</measure>
      <time_frame>1 months</time_frame>
      <description>Shoulder flexion, abduction, internal and external rotation in the supine position using a baseline goniometer; Shoulder extension ROM in the prone position was evaluated as passive.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Constant-Murley Score</measure>
      <time_frame>1 months</time_frame>
      <description>Developed in 1987, this scoring system evaluates pain, activities of daily living, strength, and ROM. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. In the original publication, the pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Disabilities of the Arm, Shoulder and Hand (DASH)</measure>
      <time_frame>1 months</time_frame>
      <description>The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short Form (SF-36)</measure>
      <time_frame>1 months</time_frame>
      <description>SF-36, which is one of the most preferred scales in assessing the quality of life, consists of a total of 36 questions and 8 sections. It is divided into 8 parts as physical function, social function, physical role difficulty, emotional role difficulty, mental health, energy/vitality, pain and general health perception. Each section is scored between 0-100 in itself. High scores indicate high quality of life.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Rotator Cuff Injuries</condition>
    <condition>Shoulder Pain</condition>
    <condition>Subacromial Impingement Syndrome</condition>
    <arm_group>
      <arm_group_label>Dry Cupping Therapy Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the conventional treatment, moving cup application was applied for 10 minutes twice a week. During the treatment, the patients were placed in a side-lying position with the affected side on top. Liquid petroleum jelly was applied on the skin and negative pressure was created with a manual pump, allowing the cup to be slid on the skin. Care was taken to ensure that the negative pressure would not cause increased pain and would allow the cup to slide. Deltoid, Trapeze, Supraspinatus, Infraspinatus, Pectoral muscles were applied in the origo insertion direction for a total of 10 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conservative Treatment Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The patients in the control group received a conservative treatment program including hotpack (20 min), transcutaneous electrical nerve stimulation(TENS) (COMPEX Rehab 400 - 20 min), ultrasound (Chattanooga Ultrasound - 1 megahertz, 1.5 W/cm², 5 min) for 4 weeks, 5 days a week, and wand, Codman, stretching and strengthening exercises were applied.Stretching exercises were added to the treatment for the shoulder girdle and scapular region muscles, while strengthening exercises were added to the treatment by increasing the resistance at the pain limit. In addition, the home exercise program was taught to be 10 repetitions 2 times a day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dry Cupping Therapy</intervention_name>
      <arm_group_label>Dry Cupping Therapy Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound</intervention_name>
      <arm_group_label>Conservative Treatment Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  25-70 age range&#xD;
  &#xD;
            -  Clinical diagnosis ofRCI, SIS, supraspinatus tendinitis&#xD;
  &#xD;
            -  To be fully cooperative&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who had undergone any surgical operation on the shoulder&#xD;
  &#xD;
            -  a history of shoulder fracture&#xD;
  &#xD;
            -  severe osteoporosis&#xD;
  &#xD;
            -  total tendon rupture&#xD;
  &#xD;
            -  had received oral/intramuscular steroids in the last 1 month&#xD;
  &#xD;
            -  had been administered intra-articular drugs in the last 3 months&#xD;
  &#xD;
            -  difficulty in cooperation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Esra ATILGAN</last_name>
      <role>Study Director</role>
      <affiliation>Medipol University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hatice Hümeyra AKIL</last_name>
      <role>Principal Investigator</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sümeyye TUNÇ</last_name>
      <role>Study Chair</role>
      <affiliation>Medipol University</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
      <investigator_full_name>sumeyye tunc</investigator_full_name>
      <investigator_title>PhD, PT, Asist. Prof.</investigator_title>
    </responsible_party>
    <keyword>Complementary Therapies</keyword>
    <keyword>Cupping Therapy</keyword>
    <keyword>Range of Motion</keyword>
    <keyword>Rotator Cuff Injuries</keyword>
    <keyword>Shoulder Pain</keyword>
    <keyword>Quality of Life</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>
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Rotator Cuff Injuries</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/NCT05975801
  org study id: Medipol University Hospital
  secondary id: Medipol University
  nct id: NCT05975801
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Shoulder pain is the most common musculoskeletal problem after spine and knee complaints.
        Rotator cuff injuries (RCI) are the most common cause of shoulder pain. RCI includes a wide
        spectrum from subacromial impingement syndrome (SIS) to chronic tendinopathy, partial and
        total ruptures of the rotator cuff. In recent years there has been a renewed interest in
        traditional and complementary medicine (TCM) for various musculoskeletal problems. Cupping
        therapy, which is one of the most commonly used TCM methods, is one of the oldest medical
        applications with thousands of years of history. Although it is thought to be effective in
        many diseases, there are not enough studies in the literature about its effectiveness and
        mechanism of action. Our aim in this study is to investigate the effects of moving dry
        cupping therapy on pain, range of motion (ROM), functionality and quality of life in RCI.
  Shoulder pain is the most common musculoskeletal problem after spine and knee complaints.
        Rotator cuff injuries (RCI) are the most common cause of shoulder pain. RCI includes a wide
        spectrum from subacromial impingement syndrome (SIS) to chronic tendinopathy, partial and
        total ruptures of the rotator cuff. Conservative and surgical techniques are used in the
        treatment. Conservative treatments; various medical treatments, activity modifications, hot
        and cold agents, exercise, manual therapy, acupuncture, electrophysical agents, etc. includes
        applications. In recent years there has been a renewed interest in traditional and
        complementary medicine (TCM) for various musculoskeletal problems. Cupping therapy is an
        ancient TCM treatment that has been practiced in different ways in many cultures in Asia,
        Europe and the Middle East throughout history, but its true origin remains unclear. Although
        cupping therapy has been used to treat pain and various complaints for thousands of years, it
        has almost disappeared from the therapeutic spectrum of Western medicine with pharmacological
        developments in the late 20th century. However, over the past few years, interest in the cup
        has increased, and new clinical research suggests that the cup may be potentially effective
        in the management of painful conditions, in the treatment of pain-related diseases. Although
        it is stated in the literature that it is used in the treatment of many neuromusculoskeletal
        problems, according to the information participants have obtained in the relevant literature,
        there is not yet a study examining the effects of cupping therapy in RCI. In the light of
        these data, our aim in this study is to investigate the effects of moving dry cupping therapy
        on pain, range of motion (ROM), functionality and quality of life in RCI.Hypotheses:
  
        H0: Cupping therapy has no effect on improving pain, ROM, functionality and quality of life
        in individuals with RCI.
  
        H1: Cupping therapy has an effect on improving pain, ROM, functionality and quality of life
        in individuals with RCI.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Shoulder pain
  time frame: 1 months
  description: Pain was evaluated with the Numerical Rating Scale (NRS). The patient was asked to mark his pain in numerical values ranging from 0 (no pain) to 10 (very severe pain). The higher the score obtained from this test, the more pain the patient has, and the smaller the score, the less the pain is predicted.
  measure: Range of Motion
  time frame: 1 months
  description: Shoulder flexion, abduction, internal and external rotation in the supine position using a baseline goniometer; Shoulder extension ROM in the prone position was evaluated as passive.
  measure: Constant-Murley Score
  time frame: 1 months
  description: Developed in 1987, this scoring system evaluates pain, activities of daily living, strength, and ROM. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. In the original publication, the pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points
  measure: The Disabilities of the Arm, Shoulder and Hand (DASH)
  time frame: 1 months
  description: The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
  measure: Short Form (SF-36)
  time frame: 1 months
  description: SF-36, which is one of the most preferred scales in assessing the quality of life, consists of a total of 36 questions and 8 sections. It is divided into 8 parts as physical function, social function, physical role difficulty, emotional role difficulty, mental health, energy/vitality, pain and general health perception. Each section is scored between 0-100 in itself. High scores indicate high quality of life.
  arm group label: Dry Cupping Therapy Group
  arm group type: Experimental
  description: In addition to the conventional treatment, moving cup application was applied for 10 minutes twice a week. During the treatment, the patients were placed in a side-lying position with the affected side on top. Liquid petroleum jelly was applied on the skin and negative pressure was created with a manual pump, allowing the cup to be slid on the skin. Care was taken to ensure that the negative pressure would not cause increased pain and would allow the cup to slide. Deltoid, Trapeze, Supraspinatus, Infraspinatus, Pectoral muscles were applied in the origo insertion direction for a total of 10 minutes.
  arm group label: Conservative Treatment Group
  arm group type: Other
  description: The patients in the control group received a conservative treatment program including hotpack (20 min), transcutaneous electrical nerve stimulation(TENS) (COMPEX Rehab 400 - 20 min), ultrasound (Chattanooga Ultrasound - 1 megahertz, 1.5 W/cm², 5 min) for 4 weeks, 5 days a week, and wand, Codman, stretching and strengthening exercises were applied.Stretching exercises were added to the treatment for the shoulder girdle and scapular region muscles, while strengthening exercises were added to the treatment by increasing the resistance at the pain limit. In addition, the home exercise program was taught to be 10 repetitions 2 times a day.
  intervention type: Other
  intervention name: Dry Cupping Therapy
  arm group label: Dry Cupping Therapy Group
  intervention type: Other
  intervention name: Conservative Treatment (hotpack, transcutaneous electrical nerve stimulation(TENS), ultrasound
  arm group label: Conservative Treatment Group
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Esra ATILGAN
  role: Study Director
  affiliation: Medipol University
  last name: Hatice Hümeyra AKIL
  role: Principal Investigator
  affiliation: Uskudar University
  last name: Sümeyye TUNÇ
  role: Study Chair
  affiliation: Medipol University
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medipol University Hospital
  investigator full name: sumeyye tunc
  investigator title: PhD, PT, Asist. Prof.
  mesh term: Shoulder Pain
  mesh term: Shoulder Impingement Syndrome
  mesh term: Wounds and Injuries
  mesh term: Rotator Cuff Injuries