<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/NCT04420403</url>
  </required_header>
  <id_info>
    <org_study_id>2020/05/28</org_study_id>
    <nct_id>NCT04420403</nct_id>
  </id_info>
  <brief_title>Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain</brief_title>
  <official_title>Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise on Balance, Proprioception, and Neck Muscle Morphology in Chronic Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk Training and Research 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>
      This study aims to investigate the effectiveness of manual therapy plus cervical&#xD;
      stabilization exercise compared to manual therapy alone on balance, proprioception, and neck&#xD;
      muscle morphology in chronic neck pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neck pain is defined as pain and/or stiffness localized to the dorsal area of the area&#xD;
      between the condyle of the occiput and the third thoracic vertebra. Chronic neck pain (CNP),&#xD;
      defined as persistent pain lasting three or more mounts, causes disability and a reduction in&#xD;
      life quality. Balance disorders or postural instability, a deficit in proprioception, changes&#xD;
      in muscle recruitment, a decrease in dimension of deep cervical muscle, and an increase in&#xD;
      stiffness of superficial neck muscle may lead to pain in patients with CNP. Both manual&#xD;
      therapy and exercise have favorable effects on management with CNP. According to our&#xD;
      knowledge, no study has investigated the effects of manual therapy plus cervical&#xD;
      stabilization exercise on balance, proprioception, and neck muscle morphology in CNP, yet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">June 24, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>Participants were randomly assigned to manual therapy plus cervical stabilization exercise group (intervention group) and only the manual therapy group (control group).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>The balance will be evaluated with Biodex BioSwayTM Balance Evaluation System. It reliably measures the patient's ability to balance on soft and/or hard ground.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proprioception</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>Proprioception will be assessed with dual digital inclinometer. The feet of the inclinometers will be placed as simultaneously as possible over the head of the patients and the cervical seventh vertebra. Firstly, patients will be asked to move their heads forward as possible as from the neutral position and then they will try to find neutral position from reached position. The angle on digital display of inclinometer will be recorded as degree. Each test will be repeated 3 times and the average deviation error score will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle morphology</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>The thickness and stiffness of the neck muscles will be evaluated by a specialist radiologist with real-time ultrasonography. It is a reliable, valid and, non-invasive method that provides an assessment of muscle morphology. Measurements will be made by using the Logiq S7 / Expert ultrasound device. The cross-sectional area of deep neck muscle with sonography, the stiffness of the superficial muscles with elastography were assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>The pain intensity will be assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, &quot;0&quot; defines &quot;no pain&quot; and &quot;10&quot; defines &quot;unbearable pain''. The participants will be asked to mark the intensity of their pain level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability level</measure>
    <time_frame>change from baseline at 6 weeks</time_frame>
    <description>The disability level will be measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients will be asked to select the most appropriate option for each section.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Manual therapy plus cervical stabilization exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients diagnosed with chronic neck pain (CNP) with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only manual therapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients diagnosed with CNP with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.</description>
    <arm_group_label>Manual therapy plus cervical stabilization exercise group</arm_group_label>
    <arm_group_label>Only manual therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical Stabilazation Exercise (CSE)</intervention_name>
    <description>The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.</description>
    <arm_group_label>Manual therapy plus cervical stabilization exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20 to 55 years of age,&#xD;
&#xD;
          -  Having generalized neck pain for more than 3 months,&#xD;
&#xD;
          -  Being volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being pregnant,&#xD;
&#xD;
          -  Malignancy,&#xD;
&#xD;
          -  Having cervical stenosis,&#xD;
&#xD;
          -  Severe cervical spondylosis,&#xD;
&#xD;
          -  Cervical fractures and tumor,&#xD;
&#xD;
          -  Osteoporosis,&#xD;
&#xD;
          -  Positive vertebrobasilar test&#xD;
&#xD;
          -  Positive Babinski reflex&#xD;
&#xD;
          -  Neurologic deficit related to compression of the spinal root or cord,&#xD;
&#xD;
          -  Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine&#xD;
             diseases,&#xD;
&#xD;
          -  Being an inability to fulfill the questionnaires,&#xD;
&#xD;
          -  Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic&#xD;
             problems), having intervention including exercise program or physiotherapy in the&#xD;
             three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>seyda toprak celenay, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara Yildirim Beyazıt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara Yildirim Beyazit University</name>
      <address>
        <city>Ankara</city>
        <zip>06760</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Seyda TOPRAK CELENAY</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>neck pain</keyword>
  <keyword>manual therapy</keyword>
  <keyword>exercise</keyword>
  <keyword>postural control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04420403
org study id: 2020/05/28
nct id: NCT04420403
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the effectiveness of manual therapy plus cervical
      stabilization exercise compared to manual therapy alone on balance, proprioception, and neck
      muscle morphology in chronic neck pain.
Neck pain is defined as pain and/or stiffness localized to the dorsal area of the area
      between the condyle of the occiput and the third thoracic vertebra. Chronic neck pain (CNP),
      defined as persistent pain lasting three or more mounts, causes disability and a reduction in
      life quality. Balance disorders or postural instability, a deficit in proprioception, changes
      in muscle recruitment, a decrease in dimension of deep cervical muscle, and an increase in
      stiffness of superficial neck muscle may lead to pain in patients with CNP. Both manual
      therapy and exercise have favorable effects on management with CNP. According to our
      knowledge, no study has investigated the effects of manual therapy plus cervical
      stabilization exercise on balance, proprioception, and neck muscle morphology in CNP, yet.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomly assigned to manual therapy plus cervical stabilization exercise group (intervention group) and only the manual therapy group (control group).
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Balance
time frame: change from baseline at 6 weeks
description: The balance will be evaluated with Biodex BioSwayTM Balance Evaluation System. It reliably measures the patient's ability to balance on soft and/or hard ground.
measure: Proprioception
time frame: change from baseline at 6 weeks
description: Proprioception will be assessed with dual digital inclinometer. The feet of the inclinometers will be placed as simultaneously as possible over the head of the patients and the cervical seventh vertebra. Firstly, patients will be asked to move their heads forward as possible as from the neutral position and then they will try to find neutral position from reached position. The angle on digital display of inclinometer will be recorded as degree. Each test will be repeated 3 times and the average deviation error score will be recorded.
measure: Muscle morphology
time frame: change from baseline at 6 weeks
description: The thickness and stiffness of the neck muscles will be evaluated by a specialist radiologist with real-time ultrasonography. It is a reliable, valid and, non-invasive method that provides an assessment of muscle morphology. Measurements will be made by using the Logiq S7 / Expert ultrasound device. The cross-sectional area of deep neck muscle with sonography, the stiffness of the superficial muscles with elastography were assessed.
measure: Pain intensity
time frame: change from baseline at 6 weeks
description: The pain intensity will be assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants will be asked to mark the intensity of their pain level.
measure: Disability level
time frame: change from baseline at 6 weeks
description: The disability level will be measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients will be asked to select the most appropriate option for each section.
arm group label: Manual therapy plus cervical stabilization exercise group
arm group type: Experimental
description: The patients diagnosed with chronic neck pain (CNP) with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.
arm group label: Only manual therapy group
arm group type: Active Comparator
description: The patients diagnosed with CNP with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.
intervention type: Other
intervention name: Manual Therapy
description: Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.
arm group label: Manual therapy plus cervical stabilization exercise group
arm group label: Only manual therapy group
intervention type: Other
intervention name: Cervical Stabilazation Exercise (CSE)
description: The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.
arm group label: Manual therapy plus cervical stabilization exercise group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: seyda toprak celenay, PhD, PT
role: Principal Investigator
affiliation: Ankara Yildirim Beyazıt University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ataturk Training and Research Hospital
investigator full name: Seyda TOPRAK CELENAY
investigator title: associate professor
mesh term: Neck Pain
sharing ipd: No