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/NCT05969769</url>
    </required_header>
    <id_info>
      <org_study_id>Laiba Zahid</org_study_id>
      <nct_id>NCT05969769</nct_id>
    </id_info>
    <brief_title>Effect of Thoracic Mobilization in Females With Coccydynia</brief_title>
    <official_title>Effects of Thoracic Manual Mobilization Techniques in Females of Coccydynia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International 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>
        Coccydynia is common and prevalent among the females and several types of exercises and&#xD;
        electrotherapy are advised. Pain can reduced significantly with both short wave diathermy and&#xD;
        muscles stretches. There is limited evidence on indirect method like thoracic mobilization&#xD;
        techniques to improve coccydynia. This study will determine the effects of thoracic&#xD;
        mobilization techniques on coccydynia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Coccydynia, refers to pain in the coccyx region. it can be caused by various factor including&#xD;
        trauma or injury (such as falls or child birth ), repetitive strain, prolong sitting on hard&#xD;
        surface, or even idiopathic reasons. Treatment options for Coccydynia may include&#xD;
        conservative measures, such as pain medication, using cushion or donut-shaped pillows to&#xD;
        relieve pressure, applying heat or cold packs, and avoiding activities that's exacerbate the&#xD;
        pain. Physical therapy including exercises such as stretching, Muscle Energy Technique (MET)&#xD;
        can also be beneficial in some cases. Thoracic manual therapy, which involves hands-on&#xD;
        techniques applied to the thoracic spine, can indeed be beneficial for improving spine&#xD;
        mobility. While it may not directly target the coccyx itself, improving overall spinal&#xD;
        mobility can have indirect effects on coccyx pain and dysfunction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Numeric Pain Rating Scale</measure>
      <time_frame>8th Week</time_frame>
      <description>Changes from the baseline Numeric Pain Rating Scale will be used to assess pain. • The Numeric Pain Rating Scale is an eleven-point measure of pain: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain). The NPRS has shown good responsiveness in shoulder pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified OSWESTRY Low Back pain Index</measure>
      <time_frame>8th Week</time_frame>
      <description>Changes from the baseline ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time. The ODI is made up of 10 questions. Each question is scored from (o-5) m</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Coccyx Disorder</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Sustained Natural Apophyseal Glides will be performed with Muscle Energy Technique and Short Wave Diathermy as experimental group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Short wave diathermy will be given with Muscle Energy Techniques.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Thoracic Sustained Natural Apophyseal Glides</intervention_name>
      <description>Sustained Natural Apophyseal Glides 3 sets of 10 reps with 1 min rest btw sets.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Muscle Energy Techniques</intervention_name>
      <description>Short wave diathermy for 10 to 15 mins Muscle Energy Techniques of following muscles will be performed, Hip flexors muscles, Quadrates lamborum muscles, Erector spinae muscles, Piriformis muscles, PFS technique of METs Isometric hold 5-7 sec, Stretching 15 sec, Rest 30 sec.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed females coccydynia patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  6 Months past Surgery, fracture or dislocation of coccyx.&#xD;
  &#xD;
            -  Malignancy or cyst in the pelvic area.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>summra andleeb, MS(OMPT)</last_name>
      <role>Principal Investigator</role>
      <affiliation>riphah internation university</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>imran amjad, Phd</last_name>
      <phone>03324390125</phone>
      <email>imran.amjad@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rahman Medical Hospital</name>
        <address>
          <city>Peshawar</city>
          <state>KPK</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>summra andleeb, MS(0MPT)</last_name>
        <phone>03450617872</phone>
        <email>sammra.andleeb@riphah.edu.pk</email>
      </contact>
      <investigator>
        <last_name>Laiba Zahid, MS(WHPT)</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Coccyx Disorder</keyword>
    <keyword>thoracic</keyword>
    <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/NCT05969769
  org study id: Laiba Zahid
  nct id: NCT05969769
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Coccydynia is common and prevalent among the females and several types of exercises and
        electrotherapy are advised. Pain can reduced significantly with both short wave diathermy and
        muscles stretches. There is limited evidence on indirect method like thoracic mobilization
        techniques to improve coccydynia. This study will determine the effects of thoracic
        mobilization techniques on coccydynia.
  Coccydynia, refers to pain in the coccyx region. it can be caused by various factor including
        trauma or injury (such as falls or child birth ), repetitive strain, prolong sitting on hard
        surface, or even idiopathic reasons. Treatment options for Coccydynia may include
        conservative measures, such as pain medication, using cushion or donut-shaped pillows to
        relieve pressure, applying heat or cold packs, and avoiding activities that's exacerbate the
        pain. Physical therapy including exercises such as stretching, Muscle Energy Technique (MET)
        can also be beneficial in some cases. Thoracic manual therapy, which involves hands-on
        techniques applied to the thoracic spine, can indeed be beneficial for improving spine
        mobility. While it may not directly target the coccyx itself, improving overall spinal
        mobility can have indirect effects on coccyx pain and dysfunction.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Numeric Pain Rating Scale
  time frame: 8th Week
  description: Changes from the baseline Numeric Pain Rating Scale will be used to assess pain. • The Numeric Pain Rating Scale is an eleven-point measure of pain: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain). The NPRS has shown good responsiveness in shoulder pain.
  measure: Modified OSWESTRY Low Back pain Index
  time frame: 8th Week
  description: Changes from the baseline ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time. The ODI is made up of 10 questions. Each question is scored from (o-5) m
  arm group label: Experimental Group
  arm group type: Active Comparator
  description: Sustained Natural Apophyseal Glides will be performed with Muscle Energy Technique and Short Wave Diathermy as experimental group.
  arm group label: Control Group
  arm group type: Active Comparator
  description: Short wave diathermy will be given with Muscle Energy Techniques.
  intervention type: Other
  intervention name: Thoracic Sustained Natural Apophyseal Glides
  description: Sustained Natural Apophyseal Glides 3 sets of 10 reps with 1 min rest btw sets.
  arm group label: Experimental Group
  intervention type: Other
  intervention name: Muscle Energy Techniques
  description: Short wave diathermy for 10 to 15 mins Muscle Energy Techniques of following muscles will be performed, Hip flexors muscles, Quadrates lamborum muscles, Erector spinae muscles, Piriformis muscles, PFS technique of METs Isometric hold 5-7 sec, Stretching 15 sec, Rest 30 sec.
  arm group label: Control Group
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: summra andleeb, MS(OMPT)
  role: Principal Investigator
  affiliation: riphah internation university
  last name: imran amjad, Phd
  phone: 03324390125
  email: imran.amjad@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  sharing ipd: No