<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/NCT04407637</url>
  </required_header>
  <id_info>
    <org_study_id>RH_05_13_20</org_study_id>
    <nct_id>NCT04407637</nct_id>
  </id_info>
  <brief_title>Kinematic Cervical Rotation Performance in Neck Pain Patients is Improved After Cervical Treatment</brief_title>
  <acronym>DidRen</acronym>
  <official_title>Kinematic Axial Cervical Rotation Performance in Patients With Acute Non-specific Neck Pain During the DidRen Laser Test is Improved After Passive Manual Cervical Mobilizations Regardless of the Painful Spinal Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A longitudinal study is designed to assess the influence of acute non-specific neck pain on&#xD;
      kinematic parameters during a fast-head axial rotation task standardized with the DidRen&#xD;
      laser test device. First, the investigators will compare kinematic parameters between&#xD;
      patients and healthy control. Second, the investigators will assess whether neck upper or&#xD;
      lower pain location influenced kinematic parameters. Finally, the investigators will examine&#xD;
      the short-term effect of passive cervical mobilizations in patients on these kinematic&#xD;
      variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At baseline, all participants will be asked to fill in four questionnaires.&#xD;
&#xD;
        -  The Neck Disability Index (NDI), which is a self-rated instrument assessing disability&#xD;
           due to neck pain, which consist of a series of 10 questions on activities relating to&#xD;
           daily living all assessed on a 6-point scale.&#xD;
&#xD;
        -  The Numerical Pain Rating Scale (NPRS), to assess the current neck pain.&#xD;
&#xD;
        -  The Tampa scale of kinesiophobia (TSK), which is a 17-item questionnaire used to assess&#xD;
           fear of movement or re-injury, in which participants are asked to rate their level of&#xD;
           agreement with each item on a 1 (strongly disagree) to 4 (strongly agree) scale. The TSK&#xD;
           has been shown to have adequate internal consistency (coefficient alpha 0.77) and to be&#xD;
           associated with measures of behavioral avoidance and self-reported disability.A cut-off&#xD;
           score above 39 is associated with a risk for prolonged pain-related disability.&#xD;
&#xD;
        -  The French version of the Bournemouth Questionnaire based on the biopsychosocial model&#xD;
           to evaluate different dimensions in neck pain participant including the pain,&#xD;
           disability, affective and cognitive aspects of neck pain.&#xD;
&#xD;
      The investigators will assess the Fast Neck Rotation with the DidRen Test:&#xD;
&#xD;
      Also, clinical examination will include Cervical Rotation Testing, Manual Spinal Examination.&#xD;
&#xD;
        -  The Didren laser test will be performed by the participant. During the DidRen Laser&#xD;
           test, the kinematic rotation will be recorded using a validated Inertial Motion Unit&#xD;
           (IMU). After the DidRen test, participant will rate their pain using the NPRS in order&#xD;
           to assess if the pain intensity could interfere with the test performance.&#xD;
&#xD;
        -  Measurements of cervical Rotation active range of motion (ROM) will be measured by an&#xD;
           IMU. During active cervical ROM measurement participants will be asked to report any&#xD;
           familiar pain on a Numerical Pain Rating Scale (NPRS). If no pain during active movement&#xD;
           is reported, then the physiotherapist will passively move the head toward end of the ROM&#xD;
           and note any stiffness and/or reported familiar pain from the participants. A positive&#xD;
           cervical Rotation ROM test will be defined as the reproduction of stiffness and/or&#xD;
           familiar cervical spine pain during the active ROM without or with over pressure.&#xD;
&#xD;
        -  The Manual spinal examination will include Passive Physiological Intervertebral&#xD;
           Movements (PPIVM's) in lateral flexion and extension and Passive Accessory&#xD;
           Intervertebral Movements (PAIVM's), will be performed to detect the presence or absence&#xD;
           of cervical joint dysfunction and to detect the region of the dysfunction either on the&#xD;
           upper or lower region.The participant will be positioned supine for the PPIVM's and&#xD;
           prone for the PAIVM's. For the PAIVM's, the assessor will apply centrally directed&#xD;
           posterior-anterior (central P/A) force toward the spinous process or posterior-anterior&#xD;
           directed force to the articular pillars (unilateral P/A) from the upper cervical region&#xD;
           C0-1, C1-2 and C2-3 to the lower region C6-7 on each side. Any perceived resistance to&#xD;
           passive motion will be recorded. The participant will be asked to report any familiar&#xD;
           pain provocation on an NPRS. A positive test at a cervical level will be defined as a&#xD;
           report of familiar local or referred pain when the assessor rate resistance to passive&#xD;
           motion (Manual Spinal examination test have demonstrated moderate to excellent&#xD;
           intrarater and interrater reliability in patients with axial neck pain referred for&#xD;
           diagnostic facet joint blocks).&#xD;
&#xD;
      On the basis of the findings of the region of pain, subjects will enter either in the upper&#xD;
      or lower cervical region group.&#xD;
&#xD;
      Regular baseline on the fast-head rotation task strategies standardized with the &quot;DidRen&#xD;
      Laser&quot; device will be done by analyzing data from a control group constituted by asymptomatic&#xD;
      subjects. As Manual Spinal Examination (P/A) has showed more sensitivity than specificity,&#xD;
      asymptomatic subjects will also be excluded by the second assessor if during cervical&#xD;
      Rotation ROM testing procedure and/or cervical manual examination.&#xD;
&#xD;
      Evaluation of Rotation ROM, Spinal Examination and first DidRen Test, will have already been&#xD;
      completed.&#xD;
&#xD;
      The participant's treatment will include P/A mobilization . After treatment, Cervical ROM&#xD;
      testing and the assessment of the fast Neck Rotation with the DidRen Test will be undergone&#xD;
      by the participant:&#xD;
&#xD;
      The Therapist will apply PPIVM's at the symptomatic levels or PAIVM's either central&#xD;
      posterior-anterior (central P/A) directed force toward the spinous process ora&#xD;
      posterior-anterior directed force directed to the articular pillars (unilateral P/A) on&#xD;
      spinal level(s) which were primary recorded as painful sites during the first spinal&#xD;
      examination and referred to as &quot;primary painful sites&quot;. As a treatment, Maitland Grade 3 and&#xD;
      4 will be used for the joint(s) mobilization(s) and could be performed at others symptomatic&#xD;
      levels (these levels will be referred to as &quot;secondary painful sites&quot;) depending on the&#xD;
      subject's condition (which also contributes to reproduce familiar pain and /or stiffness).&#xD;
      During treatment, the Musculoskeletal Physiotherapist will note all cervical levels&#xD;
      mobilized, time and grades of movement used. The decision of the end of the treatment will be&#xD;
      decided with minimal clinically important improvement (MCI) in pain and in disability. The&#xD;
      MCI in pain is defined as a decrease by at least 2 points in pain intensity score at&#xD;
      follow-up compared to baseline. The MCI in disability was defined as a decrease by at least 1&#xD;
      point in pain related disability (ROM) score at follow-up compared to baseline.&#xD;
&#xD;
      Assessment of cervical ROM (active + over pressure) by the IMU.The treatment will be&#xD;
      performed a second time if no change occurs (MCI disability) after the first manual spinal&#xD;
      treatment.&#xD;
&#xD;
      Assessment by the Didren laser test will be performed by the participant. After the DidRen&#xD;
      test, participants will complete NPRS, in order to assess if the pain intensity could&#xD;
      interfere with the performance of the test.&#xD;
&#xD;
      Musculoskeletal experience. · For blinding purposes, a second assessor will complete the&#xD;
      DidRen Laser test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2019</start_date>
  <completion_date type="Actual">December 19, 2019</completion_date>
  <primary_completion_date type="Actual">February 2, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of head rotational speed (in °s-1)</measure>
    <time_frame>T0: Before treatment; T1: after 6 weeks</time_frame>
    <description>The head rotational speed (°s-1) was recorded using an inertial motion unit sensor. DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of head rotational acceleration (in °s-2)</measure>
    <time_frame>T0: Before treatment; T1: after 6 weeks</time_frame>
    <description>The head rotational acceleration (°s-2) was recorded using an inertial motion unit sensor. DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of head angular displacement (in °)</measure>
    <time_frame>T0: Before treatment; T1: after 6 weeks</time_frame>
    <description>The head angular displacement (°) was recorded using an inertial motion unit sensor. The DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Numerical Pain Rating Scale (NPRS).</measure>
    <time_frame>T0: Before treatment; T1: after 6 weeks</time_frame>
    <description>The Numerical Pain Rating Scale (NPRS) is a commonly used outcome to assess patients with neck pain. It uses an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>neck pain patients</arm_group_label>
    <description>Patients with acute non-specific neck pain were consecutively recruited from a private manual physiotherapy center as sample of convenience. Inclusion criteria were acute (&lt;3months) non-specific neck pain with a neck disability index (NDI) &gt; 8% and a Numerical Pain Rating Scale (NPRS) &gt;3 . Patients were excluded if they reported any of the following: a history of neck surgery, dizziness caused by neck or head movements and cervical radiculopathy diagnosed by a physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy</arm_group_label>
    <description>Healthy control participants were included if they reported a NDI &lt; 8% and a NPRS =0. They were excluded if they reported neck pain during the last year, radiating symptoms in the shoulder or arm regions, or headache. Participants with a history of neck trauma or in treatment for spinal disorders or reporting pain during the manual assessment were excluded as well.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute non-specific neck pain were consecutively recruited from a private&#xD;
        manual physiotherapy center as sample of convenience. Healthy were recruited from student&#xD;
        population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients: Inclusion criteria were acute (&lt;3months) non-specific neck pain with a neck&#xD;
             disability index (NDI) &gt; 8% and a Numerical Pain Rating Scale (NPRS) &gt;3.&#xD;
&#xD;
          -  Healthy control participants were included if they reported a NDI &lt; 8% and a NPRS =0.&#xD;
             They were excluded if they reported neck pain during the last year, radiating symptoms&#xD;
             in the shoulder or arm regions, or headache. Participants with a history of neck&#xD;
             trauma or in treatment for spinal disorders or reporting pain during the manual&#xD;
             assessment were excluded as well.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if they reported any of the following: a history of neck&#xD;
             surgery, dizziness caused by neck or head movements and cervical radiculopathy&#xD;
             diagnosed by a physician.&#xD;
&#xD;
          -  Healthy: They were excluded if they reported neck pain during the last year, radiating&#xD;
             symptoms in the shoulder or arm regions, or headache. Participants with a history of&#xD;
             neck trauma or in treatment for spinal disorders or reporting pain during the manual&#xD;
             assessment were excluded as well.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Detrembleur, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Detrembleur</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</investigator_affiliation>
    <investigator_full_name>Detrembleur</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>fast neck rotation</keyword>
  <keyword>sensorimotor control assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT04407637
org study id: RH_05_13_20
nct id: NCT04407637
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A longitudinal study is designed to assess the influence of acute non-specific neck pain on
      kinematic parameters during a fast-head axial rotation task standardized with the DidRen
      laser test device. First, the investigators will compare kinematic parameters between
      patients and healthy control. Second, the investigators will assess whether neck upper or
      lower pain location influenced kinematic parameters. Finally, the investigators will examine
      the short-term effect of passive cervical mobilizations in patients on these kinematic
      variables.
At baseline, all participants will be asked to fill in four questionnaires.

        -  The Neck Disability Index (NDI), which is a self-rated instrument assessing disability
           due to neck pain, which consist of a series of 10 questions on activities relating to
           daily living all assessed on a 6-point scale.

        -  The Numerical Pain Rating Scale (NPRS), to assess the current neck pain.

        -  The Tampa scale of kinesiophobia (TSK), which is a 17-item questionnaire used to assess
           fear of movement or re-injury, in which participants are asked to rate their level of
           agreement with each item on a 1 (strongly disagree) to 4 (strongly agree) scale. The TSK
           has been shown to have adequate internal consistency (coefficient alpha 0.77) and to be
           associated with measures of behavioral avoidance and self-reported disability.A cut-off
           score above 39 is associated with a risk for prolonged pain-related disability.

        -  The French version of the Bournemouth Questionnaire based on the biopsychosocial model
           to evaluate different dimensions in neck pain participant including the pain,
           disability, affective and cognitive aspects of neck pain.

      The investigators will assess the Fast Neck Rotation with the DidRen Test:

      Also, clinical examination will include Cervical Rotation Testing, Manual Spinal Examination.

        -  The Didren laser test will be performed by the participant. During the DidRen Laser
           test, the kinematic rotation will be recorded using a validated Inertial Motion Unit
           (IMU). After the DidRen test, participant will rate their pain using the NPRS in order
           to assess if the pain intensity could interfere with the test performance.

        -  Measurements of cervical Rotation active range of motion (ROM) will be measured by an
           IMU. During active cervical ROM measurement participants will be asked to report any
           familiar pain on a Numerical Pain Rating Scale (NPRS). If no pain during active movement
           is reported, then the physiotherapist will passively move the head toward end of the ROM
           and note any stiffness and/or reported familiar pain from the participants. A positive
           cervical Rotation ROM test will be defined as the reproduction of stiffness and/or
           familiar cervical spine pain during the active ROM without or with over pressure.

        -  The Manual spinal examination will include Passive Physiological Intervertebral
           Movements (PPIVM's) in lateral flexion and extension and Passive Accessory
           Intervertebral Movements (PAIVM's), will be performed to detect the presence or absence
           of cervical joint dysfunction and to detect the region of the dysfunction either on the
           upper or lower region.The participant will be positioned supine for the PPIVM's and
           prone for the PAIVM's. For the PAIVM's, the assessor will apply centrally directed
           posterior-anterior (central P/A) force toward the spinous process or posterior-anterior
           directed force to the articular pillars (unilateral P/A) from the upper cervical region
           C0-1, C1-2 and C2-3 to the lower region C6-7 on each side. Any perceived resistance to
           passive motion will be recorded. The participant will be asked to report any familiar
           pain provocation on an NPRS. A positive test at a cervical level will be defined as a
           report of familiar local or referred pain when the assessor rate resistance to passive
           motion (Manual Spinal examination test have demonstrated moderate to excellent
           intrarater and interrater reliability in patients with axial neck pain referred for
           diagnostic facet joint blocks).

      On the basis of the findings of the region of pain, subjects will enter either in the upper
      or lower cervical region group.

      Regular baseline on the fast-head rotation task strategies standardized with the "DidRen
      Laser" device will be done by analyzing data from a control group constituted by asymptomatic
      subjects. As Manual Spinal Examination (P/A) has showed more sensitivity than specificity,
      asymptomatic subjects will also be excluded by the second assessor if during cervical
      Rotation ROM testing procedure and/or cervical manual examination.

      Evaluation of Rotation ROM, Spinal Examination and first DidRen Test, will have already been
      completed.

      The participant's treatment will include P/A mobilization . After treatment, Cervical ROM
      testing and the assessment of the fast Neck Rotation with the DidRen Test will be undergone
      by the participant:

      The Therapist will apply PPIVM's at the symptomatic levels or PAIVM's either central
      posterior-anterior (central P/A) directed force toward the spinous process ora
      posterior-anterior directed force directed to the articular pillars (unilateral P/A) on
      spinal level(s) which were primary recorded as painful sites during the first spinal
      examination and referred to as "primary painful sites". As a treatment, Maitland Grade 3 and
      4 will be used for the joint(s) mobilization(s) and could be performed at others symptomatic
      levels (these levels will be referred to as "secondary painful sites") depending on the
      subject's condition (which also contributes to reproduce familiar pain and /or stiffness).
      During treatment, the Musculoskeletal Physiotherapist will note all cervical levels
      mobilized, time and grades of movement used. The decision of the end of the treatment will be
      decided with minimal clinically important improvement (MCI) in pain and in disability. The
      MCI in pain is defined as a decrease by at least 2 points in pain intensity score at
      follow-up compared to baseline. The MCI in disability was defined as a decrease by at least 1
      point in pain related disability (ROM) score at follow-up compared to baseline.

      Assessment of cervical ROM (active + over pressure) by the IMU.The treatment will be
      performed a second time if no change occurs (MCI disability) after the first manual spinal
      treatment.

      Assessment by the Didren laser test will be performed by the participant. After the DidRen
      test, participants will complete NPRS, in order to assess if the pain intensity could
      interfere with the performance of the test.

      Musculoskeletal experience. · For blinding purposes, a second assessor will complete the
      DidRen Laser test.
observational model: Case-Control
time perspective: Prospective
measure: Change of head rotational speed (in °s-1)
time frame: T0: Before treatment; T1: after 6 weeks
description: The head rotational speed (°s-1) was recorded using an inertial motion unit sensor. DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.
measure: Change of head rotational acceleration (in °s-2)
time frame: T0: Before treatment; T1: after 6 weeks
description: The head rotational acceleration (°s-2) was recorded using an inertial motion unit sensor. DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.
measure: Change of head angular displacement (in °)
time frame: T0: Before treatment; T1: after 6 weeks
description: The head angular displacement (°) was recorded using an inertial motion unit sensor. The DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.
measure: Change of Numerical Pain Rating Scale (NPRS).
time frame: T0: Before treatment; T1: after 6 weeks
description: The Numerical Pain Rating Scale (NPRS) is a commonly used outcome to assess patients with neck pain. It uses an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable)
arm group label: neck pain patients
description: Patients with acute non-specific neck pain were consecutively recruited from a private manual physiotherapy center as sample of convenience. Inclusion criteria were acute (<3months) non-specific neck pain with a neck disability index (NDI) > 8% and a Numerical Pain Rating Scale (NPRS) >3 . Patients were excluded if they reported any of the following: a history of neck surgery, dizziness caused by neck or head movements and cervical radiculopathy diagnosed by a physician.
arm group label: healthy
description: Healthy control participants were included if they reported a NDI < 8% and a NPRS =0. They were excluded if they reported neck pain during the last year, radiating symptoms in the shoulder or arm regions, or headache. Participants with a history of neck trauma or in treatment for spinal disorders or reporting pain during the manual assessment were excluded as well.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christine Detrembleur, PhD
role: Principal Investigator
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
investigator full name: Detrembleur
investigator title: Professor
mesh term: Neck Pain