<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/NCT04455048</url>
  </required_header>
  <id_info>
    <org_study_id>AIBU-FTR-RK-04</org_study_id>
    <nct_id>NCT04455048</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Manipulation Treatment in Cervical Region</brief_title>
  <official_title>The Effectiveness of Manipulation Treatment in Acute Cervical Region Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abant Izzet Baysal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abant Izzet Baysal 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>
      Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is&#xD;
      27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches&#xD;
      become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute neck pain is often caused by mechanical causes and can be classified as rheumatic&#xD;
      diseases, infectious and tumoral pathologies, metabolic bone diseases such as osteoporosis&#xD;
      and osteomalacia, pain reflected the cervical region. A-V malformation and syringomyelia are&#xD;
      the causes of chronic cervical pain (5). Mechanical neck pain is a non-radicular pain caused&#xD;
      by local musculoskeletal structures and is characterized by a spasm of the cervical muscles.&#xD;
      (6, 7). Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also&#xD;
      reflected in the cervical, occipital and scapular regions depending on the severity of muscle&#xD;
      spasm and the presence of trigger point in myofascial pain syndrome (9, 10). Many authors&#xD;
      have suggested that facet joints are associated with mechanical dysfunction as a common cause&#xD;
      of cervical pain (8-10).&#xD;
&#xD;
      The pain in the head and neck region affects the quality of life, cognitive and functional&#xD;
      status of the person. The most important difficulty and failure in the treatment of such pain&#xD;
      arise from the inability to diagnose the disease correctly. Good anatomical and biomechanical&#xD;
      properties of the region, comprehensive anamnesis, physical examination under static and&#xD;
      dynamic conditions, laboratory and radiological examinations are the most important&#xD;
      milestones of diagnosis (12). In most cases, medical treatment and physical therapy&#xD;
      modalities (superficial and deep heat, electrotherapy, laser, traction, massage, spa) are&#xD;
      sufficient for pain relief and recovery of function, but interventional procedures and&#xD;
      surgical procedures are needed for the fewer patient. Recently, spinal mobilization and&#xD;
      manipulation techniques can be used to relieve pain and restore function in the early stages.&#xD;
      Although it is a safe method, in order to prevent the rare complications it is necessary to&#xD;
      determine the indications of treatment correctly, to exclude contiguous cases and to apply&#xD;
      the manipulation by experts (12).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2019</start_date>
  <completion_date type="Actual">April 15, 2022</completion_date>
  <primary_completion_date type="Actual">March 16, 2022</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>Two groups with a sham control. Assessments will be performed before manipulation, immediately after first session, in the second week, and two months after the last session.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The manipulation group will receive a single session thrust manipulation and the control group will receive a sham manipulation. Outcome assessment will be performed by another investigator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain pressure threshold</measure>
    <time_frame>two weeks</time_frame>
    <description>Pain pressure threshold (PPT). was assessed with an analogue algometry (Baseline, FEl Inc. White Plains, NY,USA) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale</measure>
    <time_frame>two weeks</time_frame>
    <description>The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical range of motion</measure>
    <time_frame>two weeks</time_frame>
    <description>Cervical Range of Motion (ROM) of flexion,extension, lateral flexion and rotation were measured with basic cervical ROM device (Performance Attainment, Associates, St Paul, MN, USA) in seated position without back support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index</measure>
    <time_frame>two weeks</time_frame>
    <description>Perceived disability of patients was assessed with 10-item item Neck Disability Index (NDI),which a modified from Oswestry Low Back Pain Disability Index to assess with a score range of 0 to 50.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Perceived Effect Scale</measure>
    <time_frame>two weeks</time_frame>
    <description>Change in the perception of the symptoms after the treatment was measured by a Global Perceived Effect Scale. Patients were asked to rate change between 1 completely recovered, 4 unchanged, 7 vastly worse on a horizontal likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervicothoracic thrust manipulation</intervention_name>
    <description>The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. Thrust manipulation will be applied at the end of exhale.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervicothoracic thrust manipulation sham</intervention_name>
    <description>The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. A soft compression will be applied at the end of exhale without a thrust.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis Nonspecific neck pain (NSNP)&#xD;
&#xD;
          -  Symptoms should last longer than 2 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any known cause such as radiculopathy or neurological diseases,&#xD;
&#xD;
          -  History of neck surgery,&#xD;
&#xD;
          -  History of vertebral fracture,&#xD;
&#xD;
          -  Osteoporosis,&#xD;
&#xD;
          -  Tumor or a mass in the vertebral column,&#xD;
&#xD;
          -  Any spinal thrust manipulation contraindication,&#xD;
&#xD;
          -  Medication usage such as antiinflammatory or analgesic which might effect outcome&#xD;
             assessments,&#xD;
&#xD;
          -  History of spinal manipulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erdal Dilekçi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bolu Abant Izzet Baylsa University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ramazan KURUL, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bolu Abant Izzet Baylsa University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abant Izzet Baysal University</name>
      <address>
        <city>Bolu</city>
        <state>Merkez</state>
        <zip>14100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Sciences Faculty Bolu Abant Izzet Baysal University</name>
      <address>
        <city>Bolu</city>
        <state>Merkez</state>
        <zip>14100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>December 23, 2022</last_update_submitted>
  <last_update_submitted_qc>December 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Abant Izzet Baysal University</investigator_affiliation>
    <investigator_full_name>Ramazan KURUL</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Tape</keyword>
  <keyword>Pain</keyword>
  <keyword>Rehabilitation</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/NCT04455048
org study id: AIBU-FTR-RK-04
nct id: NCT04455048
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is
      27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches
      become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4).
Acute neck pain is often caused by mechanical causes and can be classified as rheumatic
      diseases, infectious and tumoral pathologies, metabolic bone diseases such as osteoporosis
      and osteomalacia, pain reflected the cervical region. A-V malformation and syringomyelia are
      the causes of chronic cervical pain (5). Mechanical neck pain is a non-radicular pain caused
      by local musculoskeletal structures and is characterized by a spasm of the cervical muscles.
      (6, 7). Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also
      reflected in the cervical, occipital and scapular regions depending on the severity of muscle
      spasm and the presence of trigger point in myofascial pain syndrome (9, 10). Many authors
      have suggested that facet joints are associated with mechanical dysfunction as a common cause
      of cervical pain (8-10).

      The pain in the head and neck region affects the quality of life, cognitive and functional
      status of the person. The most important difficulty and failure in the treatment of such pain
      arise from the inability to diagnose the disease correctly. Good anatomical and biomechanical
      properties of the region, comprehensive anamnesis, physical examination under static and
      dynamic conditions, laboratory and radiological examinations are the most important
      milestones of diagnosis (12). In most cases, medical treatment and physical therapy
      modalities (superficial and deep heat, electrotherapy, laser, traction, massage, spa) are
      sufficient for pain relief and recovery of function, but interventional procedures and
      surgical procedures are needed for the fewer patient. Recently, spinal mobilization and
      manipulation techniques can be used to relieve pain and restore function in the early stages.
      Although it is a safe method, in order to prevent the rare complications it is necessary to
      determine the indications of treatment correctly, to exclude contiguous cases and to apply
      the manipulation by experts (12).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups with a sham control. Assessments will be performed before manipulation, immediately after first session, in the second week, and two months after the last session.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The manipulation group will receive a single session thrust manipulation and the control group will receive a sham manipulation. Outcome assessment will be performed by another investigator.
measure: Pain pressure threshold
time frame: two weeks
description: Pain pressure threshold (PPT). was assessed with an analogue algometry (Baseline, FEl Inc. White Plains, NY,USA) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.
measure: Visual analog scale
time frame: two weeks
description: The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).
measure: Cervical range of motion
time frame: two weeks
description: Cervical Range of Motion (ROM) of flexion,extension, lateral flexion and rotation were measured with basic cervical ROM device (Performance Attainment, Associates, St Paul, MN, USA) in seated position without back support.
measure: Neck Disability Index
time frame: two weeks
description: Perceived disability of patients was assessed with 10-item item Neck Disability Index (NDI),which a modified from Oswestry Low Back Pain Disability Index to assess with a score range of 0 to 50.
measure: Global Perceived Effect Scale
time frame: two weeks
description: Change in the perception of the symptoms after the treatment was measured by a Global Perceived Effect Scale. Patients were asked to rate change between 1 completely recovered, 4 unchanged, 7 vastly worse on a horizontal likert scale.
arm group label: Intervention Group
arm group type: Experimental
description: A single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks.
arm group label: Control Group
arm group type: Sham Comparator
description: A sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied.
intervention type: Other
intervention name: Cervicothoracic thrust manipulation
description: The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. Thrust manipulation will be applied at the end of exhale.
arm group label: Intervention Group
intervention type: Other
intervention name: Cervicothoracic thrust manipulation sham
description: The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. A soft compression will be applied at the end of exhale without a thrust.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Erdal Dilekçi, MD
role: Principal Investigator
affiliation: Bolu Abant Izzet Baylsa University
last name: Ramazan KURUL, Ph.D
role: Principal Investigator
affiliation: Bolu Abant Izzet Baylsa University
facility: 
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Abant Izzet Baysal University
investigator full name: Ramazan KURUL
investigator title: Assistant Professor
mesh term: Neck Pain
sharing ipd: No