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/NCT06020820</url>
    </required_header>
    <id_info>
      <org_study_id>Riphah IU Tayyaba sultan</org_study_id>
      <nct_id>NCT06020820</nct_id>
    </id_info>
    <brief_title>Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy</brief_title>
    <official_title>Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy</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>
        The aim of this research is to determine the Effects of cervical rehabilitation program on&#xD;
        neck pain, ROM and disability after thyroidectomy. Randomized controlled trials will be done&#xD;
        at Pakistan ordinance factory (POF) Hospital. The sample size will be 52. The subjects were&#xD;
        divided in two groups, with 26 subjects in Group A and 26 in Group B. Study duration was of 6&#xD;
        months. Sampling technique applied was Non probability Convenience Sampling technique. Both&#xD;
        males and females of aged 30-50 years with thyroidectomy were included. Tools used in the&#xD;
        study are Numeric Pain Rating Score (NPRS), goniometer and neck disability index (NDI).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Thyroidectomy, or surgical removal of the gland, is highly recommended treatment for thyroid&#xD;
        disorders. The most prevalent of these conditions are symptomatic benign large goiter and&#xD;
        tumorous condition of the thyroid gland. Both younger females and postmenopausal older women&#xD;
        are prevalent towards these disorders (nodular goiter, cancer, and hypothyroidism).&#xD;
  &#xD;
        Due to hyperextended position of neck during surgery patient usually complaint about the&#xD;
        posterior neck pain, movement difficulties of shoulder and neck, occipital headaches,&#xD;
        shoulder stiffness, motion's cervical range of limitations and some of them experiences the&#xD;
        discomfort symptoms such as stretching, pressing, or choking feelings in the neck, headache,&#xD;
        shoulder stiffness, and difficulty in moving the neck or shoulders. These symptoms may&#xD;
        persist for an extended period following surgery and may even have a negative effect on the&#xD;
        patient's quality of life. It has been reported that hyperextension can cause bilateral&#xD;
        hypoglossal palsy, tetraplegia and cervical artery dissection Recently, a variety of&#xD;
        treatment modalities have been used to overcome these disturbing symptoms, such as&#xD;
        intraoperative transcutaneous electrical nerve stimulation (TENS), preoperative bilateral&#xD;
        greater occipital nerve (GON) block, bilateral superficial cervical plexus block combined&#xD;
        with bilateral GON block, and postoperative neck stretching exercise. Due to surgical&#xD;
        position of thyroidectomy patient often develops posture syndrome of thyroid surgery (PSTS),&#xD;
        symptoms include postoperative nausea, vomiting, dizziness, headache and some discomfort&#xD;
        associated with neck an occipital radiating pain.&#xD;
  &#xD;
        Nepa Patel et al reported that both positional release technique and MET are effective for&#xD;
        treatment of upper trapezius tightness or trigger points as the trapezius muscle works to&#xD;
        move the neck in several directions, its degree of tightness or looseness affects neck&#xD;
        flexibility. Om C. Wadhokar et al conducted a study on patients having neck pain with TMJ&#xD;
        dysfunction, causes tightness of occipital muscles, difficulty in mouth opening and forward&#xD;
        head posture. In this study suboccipital release technique was found to be more effective&#xD;
        than conventional treatment.&#xD;
  &#xD;
        In an RCT, stretching of pectoralis along with cervical mobilizations and rotation exercises&#xD;
        were used for treatment of mechanical neck pain. And it has evaluated that it improves the&#xD;
        active range of motion in all directions, perceived pain and disability levels. In 2019,&#xD;
        Samah et al conducted a study to compare the effects the active neck stretching exercises and&#xD;
        kinesio taping on patients after thyroidectomy; a significant improvement was observed in&#xD;
        active stretching group. Another study investigated the effects of neck stretching exercises&#xD;
        on post thyroidectomy patients with complaint of neck discomfort, and it concluded that neck&#xD;
        stretching exercises are improving the patient disability level.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 25, 2022</start_date>
    <completion_date type="Actual">February 25, 2023</completion_date>
    <primary_completion_date type="Actual">January 15, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Pain Rating Score (NPRS):</measure>
      <time_frame>1 week</time_frame>
      <description>was used to assess neck pain intensity. Patients were asked to rate how bad their neck pain was on average (NPRS; range, 0, no pain, to 10, maximum pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>NDI</measure>
      <time_frame>1 Week</time_frame>
      <description>NDI is used to asses that how neck pain affects the quality of life of a person. It consists of 10 items, from 0-5 points in each item. Total score of NDI is 50 that is converted into percentage of 100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cervical flexion range of motion</measure>
      <time_frame>1 week</time_frame>
      <description>the person is asked to move neck forward to touch chin and the range is taken</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cervical extension range of motion</measure>
      <time_frame>1 week</time_frame>
      <description>the person is asked to move neck backward as far as possible and the range is taken</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cervical Rt rotation range of motion</measure>
      <time_frame>1 week</time_frame>
      <description>the person is asked to move neck sideways to Rt side like saing &quot;no&quot; and the range is taken</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cervical Lt rotation range of motion</measure>
      <time_frame>1 week</time_frame>
      <description>the person is asked to move neck sideways to Lt side like saing &quot;no&quot; and the range is taken</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cervical Rt side flexion range of motion</measure>
      <time_frame>1 week</time_frame>
      <description>the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cervical Lt side flexion range of motion</measure>
      <time_frame>1 week</time_frame>
      <description>the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">52</enrollment>
    <condition>Post-Thyroidectomy Hypoparathyroidism</condition>
    <arm_group>
      <arm_group_label>Cervical Rehabilitation program (Intervention Group) Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Positional release technique on trapezius muscle, Suboccipital muscle release, Stretching of pectoralis muscle</description>
    </arm_group>
    <arm_group>
      <arm_group_label>(control group) Group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>neck and shoulder ROMS</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cervical Rehabilitation program (Intervention Group) Group A</intervention_name>
      <description>(Positional release technique on trapezius muscle): the therapist locate and apply pressure along the tender points in the upper fibers of the trapezius. Lateral flexion of subject's head toward the side of a tender point held for 90 seconds.&#xD;
  (Suboccipital muscle release): The therapist places both his palms under the sub occipital region of the subject with his curled-up fingers and places an upward pressure causing a stretch and distraction for 30 seconds,This technique was performed 3 times in one session.&#xD;
  Stretching of pectoralis muscle:&#xD;
  Pectoralis muscle stretch were performed once daily, completing three repetitions on each side with a 30-second hold. Stretching with repetition of five, three times a day for 1week neck and soulder ROMs</description>
      <arm_group_label>Cervical Rehabilitation program (Intervention Group) Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control group group B</intervention_name>
      <description>Relax shoulders and neck sufficiently&#xD;
  look down&#xD;
  turn face to the right&#xD;
  turn face to the left&#xD;
  incline head to the right&#xD;
  incline head to the left&#xD;
  turn shoulders round and round&#xD;
  slowly raise hands fully then lower them. patients were asked to perform five repetitions of each stretching exercise, three times per day (morning, afternoon, and evening).</description>
      <arm_group_label>(control group) Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Post-thyroidectomy patients&#xD;
  &#xD;
                 -  Indoor patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Any cervical fracture/dislocations&#xD;
  &#xD;
                 -  Cervical instability&#xD;
  &#xD;
                 -  Vertebrobasilar insufficiency&#xD;
  &#xD;
                 -  Cervical Radiculopathy&#xD;
  &#xD;
                 -  Disc prolapsed at cervical region&#xD;
  &#xD;
                 -  Any neurological impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aisha Razzaq</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Pakistan ordinance factory Hospital</name>
        <address>
          <city>Wah</city>
          <state>Punjab</state>
          <zip>47010</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>range of motion</keyword>
    <keyword>disability</keyword>
    <keyword>post-thyroidectomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoparathyroidism</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/NCT06020820
  org study id: Riphah IU Tayyaba sultan
  nct id: NCT06020820
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this research is to determine the Effects of cervical rehabilitation program on
        neck pain, ROM and disability after thyroidectomy. Randomized controlled trials will be done
        at Pakistan ordinance factory (POF) Hospital. The sample size will be 52. The subjects were
        divided in two groups, with 26 subjects in Group A and 26 in Group B. Study duration was of 6
        months. Sampling technique applied was Non probability Convenience Sampling technique. Both
        males and females of aged 30-50 years with thyroidectomy were included. Tools used in the
        study are Numeric Pain Rating Score (NPRS), goniometer and neck disability index (NDI).
  Thyroidectomy, or surgical removal of the gland, is highly recommended treatment for thyroid
        disorders. The most prevalent of these conditions are symptomatic benign large goiter and
        tumorous condition of the thyroid gland. Both younger females and postmenopausal older women
        are prevalent towards these disorders (nodular goiter, cancer, and hypothyroidism).
  
        Due to hyperextended position of neck during surgery patient usually complaint about the
        posterior neck pain, movement difficulties of shoulder and neck, occipital headaches,
        shoulder stiffness, motion's cervical range of limitations and some of them experiences the
        discomfort symptoms such as stretching, pressing, or choking feelings in the neck, headache,
        shoulder stiffness, and difficulty in moving the neck or shoulders. These symptoms may
        persist for an extended period following surgery and may even have a negative effect on the
        patient's quality of life. It has been reported that hyperextension can cause bilateral
        hypoglossal palsy, tetraplegia and cervical artery dissection Recently, a variety of
        treatment modalities have been used to overcome these disturbing symptoms, such as
        intraoperative transcutaneous electrical nerve stimulation (TENS), preoperative bilateral
        greater occipital nerve (GON) block, bilateral superficial cervical plexus block combined
        with bilateral GON block, and postoperative neck stretching exercise. Due to surgical
        position of thyroidectomy patient often develops posture syndrome of thyroid surgery (PSTS),
        symptoms include postoperative nausea, vomiting, dizziness, headache and some discomfort
        associated with neck an occipital radiating pain.
  
        Nepa Patel et al reported that both positional release technique and MET are effective for
        treatment of upper trapezius tightness or trigger points as the trapezius muscle works to
        move the neck in several directions, its degree of tightness or looseness affects neck
        flexibility. Om C. Wadhokar et al conducted a study on patients having neck pain with TMJ
        dysfunction, causes tightness of occipital muscles, difficulty in mouth opening and forward
        head posture. In this study suboccipital release technique was found to be more effective
        than conventional treatment.
  
        In an RCT, stretching of pectoralis along with cervical mobilizations and rotation exercises
        were used for treatment of mechanical neck pain. And it has evaluated that it improves the
        active range of motion in all directions, perceived pain and disability levels. In 2019,
        Samah et al conducted a study to compare the effects the active neck stretching exercises and
        kinesio taping on patients after thyroidectomy; a significant improvement was observed in
        active stretching group. Another study investigated the effects of neck stretching exercises
        on post thyroidectomy patients with complaint of neck discomfort, and it concluded that neck
        stretching exercises are improving the patient disability level.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Numeric Pain Rating Score (NPRS):
  time frame: 1 week
  description: was used to assess neck pain intensity. Patients were asked to rate how bad their neck pain was on average (NPRS; range, 0, no pain, to 10, maximum pain
  measure: NDI
  time frame: 1 Week
  description: NDI is used to asses that how neck pain affects the quality of life of a person. It consists of 10 items, from 0-5 points in each item. Total score of NDI is 50 that is converted into percentage of 100.
  measure: cervical flexion range of motion
  time frame: 1 week
  description: the person is asked to move neck forward to touch chin and the range is taken
  measure: cervical extension range of motion
  time frame: 1 week
  description: the person is asked to move neck backward as far as possible and the range is taken
  measure: cervical Rt rotation range of motion
  time frame: 1 week
  description: the person is asked to move neck sideways to Rt side like saing "no" and the range is taken
  measure: cervical Lt rotation range of motion
  time frame: 1 week
  description: the person is asked to move neck sideways to Lt side like saing "no" and the range is taken
  measure: cervical Rt side flexion range of motion
  time frame: 1 week
  description: the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken
  measure: cervical Lt side flexion range of motion
  time frame: 1 week
  description: the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken
  arm group label: Cervical Rehabilitation program (Intervention Group) Group A
  arm group type: Experimental
  description: Positional release technique on trapezius muscle, Suboccipital muscle release, Stretching of pectoralis muscle
  arm group label: (control group) Group B
  arm group type: Active Comparator
  description: neck and shoulder ROMS
  intervention type: Other
  intervention name: Cervical Rehabilitation program (Intervention Group) Group A
  description: (Positional release technique on trapezius muscle): the therapist locate and apply pressure along the tender points in the upper fibers of the trapezius. Lateral flexion of subject's head toward the side of a tender point held for 90 seconds.
  (Suboccipital muscle release): The therapist places both his palms under the sub occipital region of the subject with his curled-up fingers and places an upward pressure causing a stretch and distraction for 30 seconds,This technique was performed 3 times in one session.
  Stretching of pectoralis muscle:
  Pectoralis muscle stretch were performed once daily, completing three repetitions on each side with a 30-second hold. Stretching with repetition of five, three times a day for 1week neck and soulder ROMs
  arm group label: Cervical Rehabilitation program (Intervention Group) Group A
  intervention type: Other
  intervention name: control group group B
  description: Relax shoulders and neck sufficiently
  look down
  turn face to the right
  turn face to the left
  incline head to the right
  incline head to the left
  turn shoulders round and round
  slowly raise hands fully then lower them. patients were asked to perform five repetitions of each stretching exercise, three times per day (morning, afternoon, and evening).
  arm group label: (control group) Group B
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Aisha Razzaq
  role: Principal Investigator
  affiliation: Riphah International University
  facility: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Hypoparathyroidism
  sharing ipd: No