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/NCT06031571</url>
    </required_header>
    <id_info>
      <org_study_id>cupping vs release</org_study_id>
      <nct_id>NCT06031571</nct_id>
    </id_info>
    <brief_title>Effect of Dynamic Cupping Versus Myofascial Release Therapy in Patients With Mechanical Neck Pain</brief_title>
    <official_title>Effect of Dynamic Cupping Versus Myofascial Release Therapy in Patients With Mechanical Neck Pain: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>South Valley University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>South Valley University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A randomized controlled trial will be conducted to investigate the effect of dynamic cupping&#xD;
        versus the effect of myofascial release therapy on patients with mechanical neck pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PURPOSE: To investigate the effect of dynamic cupping versus myofascial release therapy on&#xD;
        pain level, range of motion, and functional level in mechanical neck pain…&#xD;
  &#xD;
        BACKGROUND: Neck pain is a multivariate disease and is a leading issue in a modernized&#xD;
        society. The economic burden of neck pain is remarkable and includes treatment costs, reduced&#xD;
        productivity, and job-related problems (Cohen, 2015).&#xD;
  &#xD;
        There is no one definitive treatment for neck pain. However, different pharmacological and&#xD;
        non-pharmacological treatments have been recommended, including laser therapy, massage,&#xD;
        acupuncture, yoga, and aquatic therapy (Corvillo et al., 2020). However, there are no studies&#xD;
        focusing on comparing the effect of dynamic cupping and myofascial release in mechanical neck&#xD;
        pain.&#xD;
  &#xD;
        HYPOTHESES: There will be no effect of dynamic cupping versus myofascial release therapy on&#xD;
        pain level, range of motion, and functional level in patients with mechanical neck pain…&#xD;
  &#xD;
        RESEARCH QUESTION: Will there be a difference between dynamic cupping versus myofascial&#xD;
        release therapy on pain level, range of motion, and functional level in patients with&#xD;
        mechanical neck pain?&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>
      <intervention_model_description>Sixty participants will be assigned at random into 3 equal groups: group A (will receive cupping massage technique in addition to traditional exercises), group B (will receive myofascial release technique in addition to traditional exercises) and group C control group (will receive traditional exercises only) 3 sessions per week for 12 sessions .</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cervical range of motion</measure>
      <time_frame>Assessment will be done pre and post treatment sessions (3 sessions/week, total of 12 sessions in 4 weeks)</time_frame>
      <description>Cervical flexion and extension ranges of motion are measured by goniometer in numerical degrees</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neck Disability index</measure>
      <time_frame>Assessment will be done pre and post treatment sessions (3 sessions/week, total of 12 sessions in 4 weeks)</time_frame>
      <description>The neck disability index is a questionnaire has been designed to inform how neck pain has affected different aspects in everyday life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analog scale</measure>
      <time_frame>Assessment will be done pre and post treatment sessions (3 sessions/week, total of 12 sessions in 4 weeks)</time_frame>
      <description>The visual analog scale is a scale for pain severity assessment with range from 0 (o pain) to 10 (intolerable pain)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Mechanical Neck Pain</condition>
    <arm_group>
      <arm_group_label>group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>group A (will receive cupping massage technique in addition to traditional exercises)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>group B (will receive myofascial release technique in addition to traditional exercises)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>group C control group (will receive traditional exercises only)</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>dynamic cupping</intervention_name>
      <description>Dynamic cupping is a form of massage therapy that involves using Hijamat cups without skin injury while applying suction then performing circular and transverse movements</description>
      <arm_group_label>group A</arm_group_label>
      <other_name>traditional exercises (neck stretching and strengthening exercises)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Myofacial release</intervention_name>
      <description>Myofascial release is a form of manual therapy using hands-on techniques to regain tissue extensibility and elasticity</description>
      <arm_group_label>Group B</arm_group_label>
      <other_name>traditional exercises (neck stretching and strengthening exercises)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>traditional exercise (neck stretching and strengthening exercses)</intervention_name>
      <description>Stretching exercises are therapeutic exercises that aim to improve ranges of motion and tissue elasticity. Strengthening exercises are therapeutic exercises that aim to improve muscle power and maintain the gained ranges of motion</description>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_label>Group C</arm_group_label>
      <arm_group_label>group A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 18- 40 years.&#xD;
  &#xD;
            2. Body mass index is less than or equal 25 kg/m²&#xD;
  &#xD;
            3. Participants have experience mechanical neck pain for at least the previous 3 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mechanical neck pain due to trauma ,disc protrusion ,congenital deformity of the spin&#xD;
               ,spinal stenosis and rheumatoid disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of physical therapy, South Valley University</name>
        <address>
          <city>Qinā</city>
          <state>Qena</state>
          <zip>83523</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohamed GA Ali, Lecturer</last_name>
        <phone>+201014397608</phone>
        <phone_ext>+201001441982</phone_ext>
        <email>dr_m.gamal1987@svu.edu.eg</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Faculty of physical therapy</name>
        <address>
          <city>Cairo</city>
          <zip>82798</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohamed G Shehata</last_name>
        <phone>01014397608</phone>
        <email>dr_m.gamal1987@svu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>South Valley University</investigator_affiliation>
      <investigator_full_name>Mohamed Gamal Abouelyazeed Ali</investigator_full_name>
      <investigator_title>Lecturer of Physical Therapy for Women's Health</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neck Pain</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/NCT06031571
  org study id: cupping vs release
  nct id: NCT06031571
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A randomized controlled trial will be conducted to investigate the effect of dynamic cupping
        versus the effect of myofascial release therapy on patients with mechanical neck pain.
  PURPOSE: To investigate the effect of dynamic cupping versus myofascial release therapy on
        pain level, range of motion, and functional level in mechanical neck pain…
  
        BACKGROUND: Neck pain is a multivariate disease and is a leading issue in a modernized
        society. The economic burden of neck pain is remarkable and includes treatment costs, reduced
        productivity, and job-related problems (Cohen, 2015).
  
        There is no one definitive treatment for neck pain. However, different pharmacological and
        non-pharmacological treatments have been recommended, including laser therapy, massage,
        acupuncture, yoga, and aquatic therapy (Corvillo et al., 2020). However, there are no studies
        focusing on comparing the effect of dynamic cupping and myofascial release in mechanical neck
        pain.
  
        HYPOTHESES: There will be no effect of dynamic cupping versus myofascial release therapy on
        pain level, range of motion, and functional level in patients with mechanical neck pain…
  
        RESEARCH QUESTION: Will there be a difference between dynamic cupping versus myofascial
        release therapy on pain level, range of motion, and functional level in patients with
        mechanical neck pain?
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Sixty participants will be assigned at random into 3 equal groups: group A (will receive cupping massage technique in addition to traditional exercises), group B (will receive myofascial release technique in addition to traditional exercises) and group C control group (will receive traditional exercises only) 3 sessions per week for 12 sessions .
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Cervical range of motion
  time frame: Assessment will be done pre and post treatment sessions (3 sessions/week, total of 12 sessions in 4 weeks)
  description: Cervical flexion and extension ranges of motion are measured by goniometer in numerical degrees
  measure: Neck Disability index
  time frame: Assessment will be done pre and post treatment sessions (3 sessions/week, total of 12 sessions in 4 weeks)
  description: The neck disability index is a questionnaire has been designed to inform how neck pain has affected different aspects in everyday life.
  measure: Visual analog scale
  time frame: Assessment will be done pre and post treatment sessions (3 sessions/week, total of 12 sessions in 4 weeks)
  description: The visual analog scale is a scale for pain severity assessment with range from 0 (o pain) to 10 (intolerable pain)
  arm group label: group A
  arm group type: Experimental
  description: group A (will receive cupping massage technique in addition to traditional exercises)
  arm group label: Group B
  arm group type: Experimental
  description: group B (will receive myofascial release technique in addition to traditional exercises)
  arm group label: Group C
  arm group type: Active Comparator
  description: group C control group (will receive traditional exercises only)
  intervention type: Procedure
  intervention name: dynamic cupping
  description: Dynamic cupping is a form of massage therapy that involves using Hijamat cups without skin injury while applying suction then performing circular and transverse movements
  arm group label: group A
  other name: traditional exercises (neck stretching and strengthening exercises)
  intervention type: Procedure
  intervention name: Myofacial release
  description: Myofascial release is a form of manual therapy using hands-on techniques to regain tissue extensibility and elasticity
  arm group label: Group B
  other name: traditional exercises (neck stretching and strengthening exercises)
  intervention type: Procedure
  intervention name: traditional exercise (neck stretching and strengthening exercses)
  description: Stretching exercises are therapeutic exercises that aim to improve ranges of motion and tissue elasticity. Strengthening exercises are therapeutic exercises that aim to improve muscle power and maintain the gained ranges of motion
  arm group label: Group B
  arm group label: Group C
  arm group label: group A
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: South Valley University
  investigator full name: Mohamed Gamal Abouelyazeed Ali
  investigator title: Lecturer of Physical Therapy for Women's Health
  mesh term: Neck Pain