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/NCT06003907</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar65</org_study_id>
      <nct_id>NCT06003907</nct_id>
    </id_info>
    <brief_title>Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation</brief_title>
    <official_title>Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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>
        The aim of the study is to examine the effects of graston and dry cupping techniques applied&#xD;
        in addition to the conservative treatment program on neck awareness, grip strength, balance&#xD;
        and sleep quality in patients with cervical disc herniation between the ages of 18-65.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research will be carried out on 50 cases diagnosed with cervical disc herniation between&#xD;
        the ages of 18-65. The patients will be divided into 2 groups as control and experimental&#xD;
        groups by simple randomization method. While the conservative physical therapy program is&#xD;
        applied to the control group, the patients in the experimental group will be applied 1 day&#xD;
        graston and 1 day dry cup technique in addition to the ones in the experimental group. All&#xD;
        patients will be treated for 20 sessions, 5 days / 4 weeks. Fremantle Neck Awareness&#xD;
        Questionnaire to assess neck awareness, hand dynamometer to assess grip strength, Berg&#xD;
        Balance Scale to assess balance and Jenkins Sleep Scale to assess sleep quality will be used.&#xD;
        All tests will be measured at the start of treatment and after 4 weeks of intervention. Pre-&#xD;
        and post-intervention data were statistically analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 20, 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>conservative and traditional physiotherapy</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Fremantle Neck Awareness Questionnaire</measure>
      <time_frame>6 weeks</time_frame>
      <description>It is a 9-question questionnaire that evaluates the way people perceive the communication between their neck and their body, and the way they perceive their body position. Evaluates the perception that differs according to the individual. It is a Likert-type questionnaire (0 = Never/Never feel this way, 1= I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg Balance Scale</measure>
      <time_frame>6 weeks</time_frame>
      <description>The Berg Balance Scale is a scale developed for the assessment of postural control in adults and is easily used in many areas of rehabilitation. It consists of 14 items in total. Scoring evaluates whether the patient can safely perform a task in a given amount of time. High fall risk and balance disorder between 0-20 points; A score of 21-40 indicates moderate risk of falling and an acceptable balance; A score of 41 and above indicates good balance and minimal risk of falling.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Jenkins Sleep Scale</measure>
      <time_frame>6 weeks</time_frame>
      <description>The Jenkins Sleep Scale is used in clinical studies to evaluate the sleep problems of patients. Patients are asked 4 questions about sleep problems in the last month and are asked to answer them. 0 (hardly), 1 (1-3 days per month), 2 (4-7 days per month), 3 (8-14 days per month), 4 (15-21 days per month), 5 (23-31 days per month)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Neck Pain</condition>
    <condition>Cervical Disc Herniation</condition>
    <arm_group>
      <arm_group_label>conventional physiotherapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>traditional and complementary medicine methods will not be used.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cupping therapy and graston</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Complementary methods will be used alongside conventional physiotherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>conventional</intervention_name>
      <description>hot application electrotherapy ultrasound mobilization joint range of motion exercises stretching exercises balance exercises posture exercises</description>
      <arm_group_label>conventional physiotherapy</arm_group_label>
      <arm_group_label>cupping therapy and graston</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>traditional and complementary medicine methods</intervention_name>
      <description>The Graston Technique is a form of manual therapy known as instrument assisted soft tissue mobilization. Graston massage is performed using titanium-coated metal rods specially designed for different parts of the body.&#xD;
  Cupping therapy is a treatment method that creates a regional vacuum to increase the blood circulation of the person and provide healing.</description>
      <arm_group_label>cupping therapy and graston</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 18-65&#xD;
  &#xD;
            -  Being diagnosed with cervical disc herniation&#xD;
  &#xD;
            -  Being diagnosed with cervical disc herniation at the level of bulging or protrusion&#xD;
               according to MRI results&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of cervical spine surgery history&#xD;
  &#xD;
            -  Presence of primary or spinal metastatic malignancy&#xD;
  &#xD;
            -  Having vascular problems&#xD;
  &#xD;
            -  Individuals with sleep apnea&#xD;
  &#xD;
            -  Those who use psychiatric drugs&#xD;
  &#xD;
            -  Presence of various pathologies in the upper extremity (fracture, ganglion cyst, etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Beste İNCEKULAK</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Üsküdar Unıversıty</name>
        <address>
          <city>Üsküdar</city>
          <state>İstanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Keramat KU, Gaughran A. Safe physiotherapy interventions in large cervical disc herniations. BMJ Case Rep. 2012 Aug 18;2012:bcr2012006864. doi: 10.1136/bcr-2012-006864.</citation>
      <PMID>22907861</PMID>
    </reference>
    <reference>
      <citation>Crothers A, Walker B, French SD. Spinal manipulative therapy versus Graston Technique in the treatment of non-specific thoracic spine pain: design of a randomised controlled trial. Chiropr Osteopat. 2008 Oct 30;16:12. doi: 10.1186/1746-1340-16-12.</citation>
      <PMID>18959807</PMID>
    </reference>
    <reference>
      <citation>Choi TY, Ang L, Ku B, Jun JH, Lee MS. Evidence Map of Cupping Therapy. J Clin Med. 2021 Apr 17;10(8):1750. doi: 10.3390/jcm10081750.</citation>
      <PMID>33920643</PMID>
    </reference>
    <reference>
      <citation>Kim S, Lee SH, Kim MR, Kim EJ, Hwang DS, Lee J, Shin JS, Ha IH, Lee YJ. Is cupping therapy effective in patients with neck pain? A systematic review and meta-analysis. BMJ Open. 2018 Nov 5;8(11):e021070. doi: 10.1136/bmjopen-2017-021070.</citation>
      <PMID>30397006</PMID>
    </reference>
    <reference>
      <citation>Abdel-Aal NM, Elsayyad MM, Megahed AA. Short-term effect of adding Graston technique to exercise program in treatment of patients with cervicogenic headache: a single-blinded, randomized controlled trial. Eur J Phys Rehabil Med. 2021 Oct;57(5):758-766. doi: 10.23736/S1973-9087.21.06595-3. Epub 2021 May 5.</citation>
      <PMID>33947825</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>graston technique</keyword>
    <keyword>cupping therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Displacement</mesh_term>
      <mesh_term>Neck Pain</mesh_term>
      <mesh_term>Hernia</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/NCT06003907
  org study id: Uskudar65
  nct id: NCT06003907
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to examine the effects of graston and dry cupping techniques applied
        in addition to the conservative treatment program on neck awareness, grip strength, balance
        and sleep quality in patients with cervical disc herniation between the ages of 18-65.
  The research will be carried out on 50 cases diagnosed with cervical disc herniation between
        the ages of 18-65. The patients will be divided into 2 groups as control and experimental
        groups by simple randomization method. While the conservative physical therapy program is
        applied to the control group, the patients in the experimental group will be applied 1 day
        graston and 1 day dry cup technique in addition to the ones in the experimental group. All
        patients will be treated for 20 sessions, 5 days / 4 weeks. Fremantle Neck Awareness
        Questionnaire to assess neck awareness, hand dynamometer to assess grip strength, Berg
        Balance Scale to assess balance and Jenkins Sleep Scale to assess sleep quality will be used.
        All tests will be measured at the start of treatment and after 4 weeks of intervention. Pre-
        and post-intervention data were statistically analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: conservative and traditional physiotherapy
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The Fremantle Neck Awareness Questionnaire
  time frame: 6 weeks
  description: It is a 9-question questionnaire that evaluates the way people perceive the communication between their neck and their body, and the way they perceive their body position. Evaluates the perception that differs according to the individual. It is a Likert-type questionnaire (0 = Never/Never feel this way, 1= I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time)
  measure: Berg Balance Scale
  time frame: 6 weeks
  description: The Berg Balance Scale is a scale developed for the assessment of postural control in adults and is easily used in many areas of rehabilitation. It consists of 14 items in total. Scoring evaluates whether the patient can safely perform a task in a given amount of time. High fall risk and balance disorder between 0-20 points; A score of 21-40 indicates moderate risk of falling and an acceptable balance; A score of 41 and above indicates good balance and minimal risk of falling.
  measure: Jenkins Sleep Scale
  time frame: 6 weeks
  description: The Jenkins Sleep Scale is used in clinical studies to evaluate the sleep problems of patients. Patients are asked 4 questions about sleep problems in the last month and are asked to answer them. 0 (hardly), 1 (1-3 days per month), 2 (4-7 days per month), 3 (8-14 days per month), 4 (15-21 days per month), 5 (23-31 days per month)
  arm group label: conventional physiotherapy
  arm group type: Active Comparator
  description: traditional and complementary medicine methods will not be used.
  arm group label: cupping therapy and graston
  arm group type: Experimental
  description: Complementary methods will be used alongside conventional physiotherapy.
  intervention type: Other
  intervention name: conventional
  description: hot application electrotherapy ultrasound mobilization joint range of motion exercises stretching exercises balance exercises posture exercises
  arm group label: conventional physiotherapy
  arm group label: cupping therapy and graston
  intervention type: Other
  intervention name: traditional and complementary medicine methods
  description: The Graston Technique is a form of manual therapy known as instrument assisted soft tissue mobilization. Graston massage is performed using titanium-coated metal rods specially designed for different parts of the body.
  Cupping therapy is a treatment method that creates a regional vacuum to increase the blood circulation of the person and provide healing.
  arm group label: cupping therapy and graston
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Beste İNCEKULAK
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  country: Turkey
  citation: Keramat KU, Gaughran A. Safe physiotherapy interventions in large cervical disc herniations. BMJ Case Rep. 2012 Aug 18;2012:bcr2012006864. doi: 10.1136/bcr-2012-006864.
  PMID: 22907861
  citation: Crothers A, Walker B, French SD. Spinal manipulative therapy versus Graston Technique in the treatment of non-specific thoracic spine pain: design of a randomised controlled trial. Chiropr Osteopat. 2008 Oct 30;16:12. doi: 10.1186/1746-1340-16-12.
  PMID: 18959807
  citation: Choi TY, Ang L, Ku B, Jun JH, Lee MS. Evidence Map of Cupping Therapy. J Clin Med. 2021 Apr 17;10(8):1750. doi: 10.3390/jcm10081750.
  PMID: 33920643
  citation: Kim S, Lee SH, Kim MR, Kim EJ, Hwang DS, Lee J, Shin JS, Ha IH, Lee YJ. Is cupping therapy effective in patients with neck pain? A systematic review and meta-analysis. BMJ Open. 2018 Nov 5;8(11):e021070. doi: 10.1136/bmjopen-2017-021070.
  PMID: 30397006
  citation: Abdel-Aal NM, Elsayyad MM, Megahed AA. Short-term effect of adding Graston technique to exercise program in treatment of patients with cervicogenic headache: a single-blinded, randomized controlled trial. Eur J Phys Rehabil Med. 2021 Oct;57(5):758-766. doi: 10.23736/S1973-9087.21.06595-3. Epub 2021 May 5.
  PMID: 33947825
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  mesh term: Intervertebral Disc Displacement
  mesh term: Neck Pain
  mesh term: Hernia
  sharing ipd: No