<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/NCT03266224</url>
  </required_header>
  <id_info>
    <org_study_id>100-3793A3</org_study_id>
    <nct_id>NCT03266224</nct_id>
  </id_info>
  <brief_title>Digital Analysis of Ultrasonographic Images in Children With Wry Neck</brief_title>
  <official_title>Digital Analysis of Ultrasonographic Images in Children With Wry Neck</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial 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>
      Torticollis is a clinical sign or symptom that could be the result of a variety of underlying&#xD;
      disorders. Among the etiologies, Congenital muscular torticollis (CMT) with impairment of the&#xD;
      sternocleidomastoid (SCM) is the most frequent cause of torticollis in infants. CMT is a&#xD;
      postural deformity detected at birth or shortly after birth, primarily resulting from&#xD;
      unilateral shortening and fibrosis of the SCM. Infants with CMT display head tilt to one&#xD;
      side, which is often combined with rotation of the head to the opposite side. In 2002,&#xD;
      Chih-Chin Hsu et al. reported that CMT could be classified into four types. The majority of&#xD;
      Type I and II fibrosis improved after conservative treatment. However, Type III and Type IV&#xD;
      had more probability in need of surgical correction. However, this categorization lacks of&#xD;
      objective and quantitative measurement and can be different by subjective judgement of&#xD;
      different physicians. The purpose of this study is tried to perform digital analysis of&#xD;
      ultrasonography images to establish an objective, quantitative method and to assess its&#xD;
      relevance with clinical symptoms and prognosis.&#xD;
&#xD;
      This study will collect the children younger than one year-old who were impressed or&#xD;
      suspected to have torticollis in physical medicine and rehabilitation clinic to assess the&#xD;
      relationship between digitalization results of ultrasound image and clinical manifestations&#xD;
      and prognosis. Digital image analysis of ultrasound which contains both sides of the SCM in&#xD;
      transverse and longitudinal view for comparison of lesion side and sound side will be&#xD;
      performed after the initial enrollment and every six months later. Evaluation of clinical&#xD;
      manifestations includes measurement of side difference of angles in bilateral neck lateral&#xD;
      flexion, rotation and habitual head position will performed using an arthrodial protractor by&#xD;
      a trained member at the beginning of physical therapy and one month later, then every 2-3&#xD;
      months. All cases will be followed for 1 and a half years. We expect to find some typical&#xD;
      characteristics of CMT through digital analysis of the SCM. These characteristics include the&#xD;
      muscle thickness and intensity of echogenicity in the region of interest. The Pearson's&#xD;
      correlation will be performed to analyze the relevance of quantitative side differences in&#xD;
      ultrasonography and clinical manifestations including side differences of neck rotation,&#xD;
      lateral flexion and habitual head position between lesion sides and sound sides.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Torticollis is a clinical sign or symptom that could be the result of a variety of underlying&#xD;
      disorders. Among the etiologies, Congenital muscular torticollis (CMT) with impairment of the&#xD;
      sternocleidomastoid (SCM) is the most frequent cause of torticollis in infants. CMT is a&#xD;
      postural deformity detected at birth or shortly after birth, primarily resulting from&#xD;
      unilateral shortening and fibrosis of the SCM muscle. Infants with CMT display head tilt to&#xD;
      one side, which is often combined with rotation of the head to the opposite side. CMT is&#xD;
      estimated to occur in one infant of every 300 live births. Plagiocephaly is reported as a&#xD;
      coexisting impairment in 80% to 90.1% of children with CMT.&#xD;
&#xD;
      The pathophysiology and etiology of SCM impairment in CMT is still unknown. Prominent&#xD;
      theories related to the cause of SCM impairment in CMT include intrauterine crowding, muscle&#xD;
      trauma during a difficult delivery, soft tissue compression leading to compartment syndrome,&#xD;
      and congenital abnormalities of soft tissue differentiation within the SCM muscle.&#xD;
&#xD;
      Children with CMT can be assigned to one of three clinical subgroups: 1) children with a&#xD;
      palpable swelling or pseudotumor of the sternocleidomastoid, 2) children with SCM tightness&#xD;
      but no tumor, and 3) children with all the features of muscular torticollis without muscle&#xD;
      tightness or tumor.&#xD;
&#xD;
      In 2002, Chih-Chin Hsu et al. reported that CMT could be classified into four types. Type I&#xD;
      denoted a heteroechoic mass in the affected muscles; Type II represented diffuse echogenic&#xD;
      dots and lines against the hypoechoic background with no detectable mass. The alignment of&#xD;
      perimysium appeared irregular instead of parallel on longitudinal sonograms; Type III&#xD;
      indicated diffuse hyperechoic echogenicity along the entire muscle and almost no hypoechoic&#xD;
      background could be seen; and Type IV had a hyperechoic band in the involved muscles. The&#xD;
      study also evaluated the histology of each type of fibrosis. Type I and II fibrosis revealed&#xD;
      hyperplastic fibrous tissue mingled with muscle fiber. Mature fibroblasts with complete&#xD;
      absence of normal muscle tissue could be found in Type III fibrosis and the fibrotic bands in&#xD;
      Type IV fibrosis. The majority of Type I and II fibrosis improved after conservative&#xD;
      treatment. However, Type III and Type IV had more probability in need of surgical correction.&#xD;
      However, this categorization lacks of objective and quantitative measurement and can be&#xD;
      different by subjective judgement of different physicians. The purpose of this study is tried&#xD;
      to perform digital analysis of ultrasonography images to establish an objective, quantitative&#xD;
      method and to assess its relevance with clinical symptoms and prognosis.&#xD;
&#xD;
      General Design:&#xD;
&#xD;
      This study is planned to quantify ultrasonography image of wry neck patients by digital&#xD;
      analysis.&#xD;
&#xD;
      Subjects:&#xD;
&#xD;
      This study will collect the children younger than 1 y/o who were impressed or suspected to&#xD;
      have torticollis in physical medicine and rehabilitation clinic. The case number is estimated&#xD;
      around 60 in a 3-year-period enrollment. . Exclusion criteria include torticollis by other&#xD;
      known causes like strabismus, trauma, neurogenic problems, congenital malformation or bony&#xD;
      deformity (e.g. hemivertebrae of cervical spine). Informed consent will be given to the&#xD;
      parents before enrollment.&#xD;
&#xD;
      Investigation Steps:&#xD;
&#xD;
        1. Ultrasonography examination and digital analysis:&#xD;
&#xD;
           Ultrasonography which contains both sides of the sternocleidomastoid muscle in&#xD;
           transverse and longitudinal view for comparison of lesion side and sound side will be&#xD;
           performed by expert physicians using a 14-megahertz linear-array transducer after the&#xD;
           initial enrollment and every six months later. Digital analysis of the images will be&#xD;
           carried by a member expert in computer science.&#xD;
&#xD;
        2. Evaluation of clinical manifestations:&#xD;
&#xD;
           Evaluation of clinical manifestations includes measurement of side difference of angles&#xD;
           in bilateral neck lateral flexion, rotation and habitual head position will performed&#xD;
           using an arthrodial protractor by a trained member at the beginning of physical therapy&#xD;
           and one month later, then every 2-3 months. Each measurement will be repeated 3 times to&#xD;
           get the mean value. All cases will be followed for 1 and a half years, however, if the&#xD;
           symptoms got completely recovery (the neck range of motion and position completely equal&#xD;
           to sound side) or any complications resulting from the evaluation, the evaluation will&#xD;
           be stopped.&#xD;
&#xD;
        3. Evaluation of influence of rehabilitation effect:&#xD;
&#xD;
      The parents will be inquired by a questionnaire one month later and then every 2-3 months to&#xD;
      realize the treatment effect of the wry neck. The duration and frequency of massage and&#xD;
      stretch programs by the therapist or the family or the other methods to treat the problem&#xD;
      like wearing a neck collar, proper positioning… etc will be included in the semi-quantitative&#xD;
      questionnaire.&#xD;
&#xD;
      Data Analysis:&#xD;
&#xD;
      Some representative image features will be expected to be computed from the SCM ultrasonic&#xD;
      images. These features include area, both max and min Feret's diameters, and brightness of&#xD;
      echogenicity in the region of interest. The ultrasonic image of the affected side would be&#xD;
      compared with that of the sound side from their corresponding texture features. The Pearson's&#xD;
      correlation will be performed to analyze the relevance of quantitative side differences of&#xD;
      texture features in ultrasonography and clinical manifestations including side differences of&#xD;
      neck rotation, lateral flexion and habitual head position between lesion sides and sound&#xD;
      sides. Linear regression will be also used to adjust the influence of the treatment effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2013</start_date>
  <completion_date type="Actual">August 15, 2015</completion_date>
  <primary_completion_date type="Actual">August 15, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cervical passive range of motion</measure>
    <time_frame>From the date of beginning of physical therapy until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.</time_frame>
    <description>Measurement with an arthrodial protractor by a trained physiotherapist at the beginning of physical therapy and one month later, then every 2-3 months. Each measurement will be repeated 3 times to get the mean value.. All cases will be followed for 1 and a half years, however, if the symptoms got completely recovery (the neck range of motion and position completely equal to sound side) or any complications resulting from the evaluation, the evaluation will be stopped.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area in cm^2</measure>
    <time_frame>From the date of initial enrollment until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.</time_frame>
    <description>Ultrasonography which contains both sides of the sternocleidomastoid muscle in transverse and longitudinal view for comparison of lesion side and sound side will be performed by expert physicians using a 14-megahertz linear-array transducer after the initial enrollment and every six months later. Digital analysis of the images will be carried by a member expert in computer science. The area was measured in pixels on the original image. Thus, dividing by the pixels of one square centimeter on each sonogram, the unit of the area was converted to square centimeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brightness of echogenicity in %</measure>
    <time_frame>From the date of initial enrollment until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.</time_frame>
    <description>Ultrasonography which contains both sides of the sternocleidomastoid muscle in transverse and longitudinal view for comparison of lesion side and sound side will be performed by expert physicians using a 14-megahertz linear-array transducer after the initial enrollment and every six months later. Digital analysis of the images will be carried by a member expert in computer science. The sonograms were grayscale images, and the mean gray value was measured from 0 to 255 in the image analysis software where zero was designated black and 255 was designated white. Therefore, the mean gray value was divided by 255 and then converted to a percentage. In this study, zero percent was designated black, and 100% was designated white and indicated the brightness of the echogenicity on the sonogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>max Feret's diameter in cm</measure>
    <time_frame>From the date of initial enrollment until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.</time_frame>
    <description>Ultrasonography which contains both sides of the sternocleidomastoid muscle in transverse and longitudinal view for comparison of lesion side and sound side will be performed by expert physicians using a 14-megahertz linear-array transducer after the initial enrollment and every six months later. Digital analysis of the images will be carried by a member expert in computer science. The max Feret's diameter was measured in pixels on the original image. Thus, dividing by the pixels of one centimeter on each sonogram, the unit of the max Feret's diameter was converted to centimeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>min Feret's diameter in cm</measure>
    <time_frame>From the date of initial enrollment until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.</time_frame>
    <description>Ultrasonography which contains both sides of the sternocleidomastoid muscle in transverse and longitudinal view for comparison of lesion side and sound side will be performed by expert physicians using a 14-megahertz linear-array transducer after the initial enrollment and every six months later. Digital analysis of the images will be carried by a member expert in computer science. The min Feret's diameter was measured in pixels on the original image. Thus, dividing by the pixels of one centimeter on each sonogram, the unit of the min Feret's diameter was converted to centimeter.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Torticollis Congenital</condition>
  <condition>Wryneck</condition>
  <arm_group>
    <arm_group_label>Wryneck</arm_group_label>
    <description>those with a condition</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. infants with congenital muscular torticollis and&#xD;
&#xD;
          2. age &lt;12 months at diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) wryneck caused by other known problems, including strabismus, trauma, neurogenic&#xD;
        problems, congenital malformation, or bony deformity (e.g., hemivertebrae of the cervical&#xD;
        spine)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chu-Hsu Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Cheng JC, Tang SP, Chen TM, Wong MW, Wong EM. The clinical presentation and outcome of treatment of congenital muscular torticollis in infants--a study of 1,086 cases. J Pediatr Surg. 2000 Jul;35(7):1091-6. doi: 10.1053/jpsu.2000.7833.</citation>
    <PMID>10917303</PMID>
  </reference>
  <reference>
    <citation>Canale ST, Griffin DW, Hubbard CN. Congenital muscular torticollis. A long-term follow-up. J Bone Joint Surg Am. 1982 Jul;64(6):810-6.</citation>
    <PMID>7085709</PMID>
  </reference>
  <reference>
    <citation>Hollier L, Kim J, Grayson BH, McCarthy JG. Congenital muscular torticollis and the associated craniofacial changes. Plast Reconstr Surg. 2000 Mar;105(3):827-35. doi: 10.1097/00006534-200003000-00001. No abstract available.</citation>
    <PMID>10724239</PMID>
  </reference>
  <reference>
    <citation>Cheng JC, Wong MW, Tang SP, Chen TM, Shum SL, Wong EM. Clinical determinants of the outcome of manual stretching in the treatment of congenital muscular torticollis in infants. A prospective study of eight hundred and twenty-one cases. J Bone Joint Surg Am. 2001 May;83(5):679-87. doi: 10.2106/00004623-200105000-00006.</citation>
    <PMID>11379737</PMID>
  </reference>
  <reference>
    <citation>Clarren SK, Smith DW, Hanson JW. Helmet treatment for plagiocephaly and congenital muscular torticollis. J Pediatr. 1979 Jan;94(1):43-6. doi: 10.1016/s0022-3476(79)80347-9.</citation>
    <PMID>758420</PMID>
  </reference>
  <reference>
    <citation>Cheng JC, Au AW. Infantile torticollis: a review of 624 cases. J Pediatr Orthop. 1994 Nov-Dec;14(6):802-8.</citation>
    <PMID>7814599</PMID>
  </reference>
  <reference>
    <citation>Dunn PM. Congenital postural deformities. Br Med Bull. 1976 Jan;32(1):71-6. doi: 10.1093/oxfordjournals.bmb.a071327. No abstract available.</citation>
    <PMID>130955</PMID>
  </reference>
  <reference>
    <citation>Ling CM, Low YS. Sternomastoid tumor and muscular torticollis. Clin Orthop Relat Res. 1972 Jul-Aug;86:144-50. doi: 10.1097/00003086-197207000-00020. No abstract available.</citation>
    <PMID>5065412</PMID>
  </reference>
  <reference>
    <citation>Davids JR, Wenger DR, Mubarak SJ. Congenital muscular torticollis: sequela of intrauterine or perinatal compartment syndrome. J Pediatr Orthop. 1993 Mar-Apr;13(2):141-7.</citation>
    <PMID>8459000</PMID>
  </reference>
  <reference>
    <citation>Tang S, Liu Z, Quan X, Qin J, Zhang D. Sternocleidomastoid pseudotumor of infants and congenital muscular torticollis: fine-structure research. J Pediatr Orthop. 1998 Mar-Apr;18(2):214-8.</citation>
    <PMID>9531404</PMID>
  </reference>
  <reference>
    <citation>Tang SF, Hsu KH, Wong AM, Hsu CC, Chang CH. Longitudinal followup study of ultrasonography in congenital muscular torticollis. Clin Orthop Relat Res. 2002 Oct;(403):179-85. doi: 10.1097/00003086-200210000-00026.</citation>
    <PMID>12360024</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chu-Hsu Lin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>congenital muscular torticollis</keyword>
  <keyword>wryneck</keyword>
  <keyword>sternocleidomastoid</keyword>
  <keyword>ultrasonography</keyword>
  <keyword>digital analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Torticollis</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/NCT03266224
org study id: 100-3793A3
nct id: NCT03266224
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Torticollis is a clinical sign or symptom that could be the result of a variety of underlying
      disorders. Among the etiologies, Congenital muscular torticollis (CMT) with impairment of the
      sternocleidomastoid (SCM) is the most frequent cause of torticollis in infants. CMT is a
      postural deformity detected at birth or shortly after birth, primarily resulting from
      unilateral shortening and fibrosis of the SCM. Infants with CMT display head tilt to one
      side, which is often combined with rotation of the head to the opposite side. In 2002,
      Chih-Chin Hsu et al. reported that CMT could be classified into four types. The majority of
      Type I and II fibrosis improved after conservative treatment. However, Type III and Type IV
      had more probability in need of surgical correction. However, this categorization lacks of
      objective and quantitative measurement and can be different by subjective judgement of
      different physicians. The purpose of this study is tried to perform digital analysis of
      ultrasonography images to establish an objective, quantitative method and to assess its
      relevance with clinical symptoms and prognosis.

      This study will collect the children younger than one year-old who were impressed or
      suspected to have torticollis in physical medicine and rehabilitation clinic to assess the
      relationship between digitalization results of ultrasound image and clinical manifestations
      and prognosis. Digital image analysis of ultrasound which contains both sides of the SCM in
      transverse and longitudinal view for comparison of lesion side and sound side will be
      performed after the initial enrollment and every six months later. Evaluation of clinical
      manifestations includes measurement of side difference of angles in bilateral neck lateral
      flexion, rotation and habitual head position will performed using an arthrodial protractor by
      a trained member at the beginning of physical therapy and one month later, then every 2-3
      months. All cases will be followed for 1 and a half years. We expect to find some typical
      characteristics of CMT through digital analysis of the SCM. These characteristics include the
      muscle thickness and intensity of echogenicity in the region of interest. The Pearson's
      correlation will be performed to analyze the relevance of quantitative side differences in
      ultrasonography and clinical manifestations including side differences of neck rotation,
      lateral flexion and habitual head position between lesion sides and sound sides.
Torticollis is a clinical sign or symptom that could be the result of a variety of underlying
      disorders. Among the etiologies, Congenital muscular torticollis (CMT) with impairment of the
      sternocleidomastoid (SCM) is the most frequent cause of torticollis in infants. CMT is a
      postural deformity detected at birth or shortly after birth, primarily resulting from
      unilateral shortening and fibrosis of the SCM muscle. Infants with CMT display head tilt to
      one side, which is often combined with rotation of the head to the opposite side. CMT is
      estimated to occur in one infant of every 300 live births. Plagiocephaly is reported as a
      coexisting impairment in 80% to 90.1% of children with CMT.

      The pathophysiology and etiology of SCM impairment in CMT is still unknown. Prominent
      theories related to the cause of SCM impairment in CMT include intrauterine crowding, muscle
      trauma during a difficult delivery, soft tissue compression leading to compartment syndrome,
      and congenital abnormalities of soft tissue differentiation within the SCM muscle.

      Children with CMT can be assigned to one of three clinical subgroups: 1) children with a
      palpable swelling or pseudotumor of the sternocleidomastoid, 2) children with SCM tightness
      but no tumor, and 3) children with all the features of muscular torticollis without muscle
      tightness or tumor.

      In 2002, Chih-Chin Hsu et al. reported that CMT could be classified into four types. Type I
      denoted a heteroechoic mass in the affected muscles; Type II represented diffuse echogenic
      dots and lines against the hypoechoic background with no detectable mass. The alignment of
      perimysium appeared irregular instead of parallel on longitudinal sonograms; Type III
      indicated diffuse hyperechoic echogenicity along the entire muscle and almost no hypoechoic
      background could be seen; and Type IV had a hyperechoic band in the involved muscles. The
      study also evaluated the histology of each type of fibrosis. Type I and II fibrosis revealed
      hyperplastic fibrous tissue mingled with muscle fiber. Mature fibroblasts with complete
      absence of normal muscle tissue could be found in Type III fibrosis and the fibrotic bands in
      Type IV fibrosis. The majority of Type I and II fibrosis improved after conservative
      treatment. However, Type III and Type IV had more probability in need of surgical correction.
      However, this categorization lacks of objective and quantitative measurement and can be
      different by subjective judgement of different physicians. The purpose of this study is tried
      to perform digital analysis of ultrasonography images to establish an objective, quantitative
      method and to assess its relevance with clinical symptoms and prognosis.

      General Design:

      This study is planned to quantify ultrasonography image of wry neck patients by digital
      analysis.

      Subjects:

      This study will collect the children younger than 1 y/o who were impressed or suspected to
      have torticollis in physical medicine and rehabilitation clinic. The case number is estimated
      around 60 in a 3-year-period enrollment. . Exclusion criteria include torticollis by other
      known causes like strabismus, trauma, neurogenic problems, congenital malformation or bony
      deformity (e.g. hemivertebrae of cervical spine). Informed consent will be given to the
      parents before enrollment.

      Investigation Steps:

        1. Ultrasonography examination and digital analysis:

           Ultrasonography which contains both sides of the sternocleidomastoid muscle in
           transverse and longitudinal view for comparison of lesion side and sound side will be
           performed by expert physicians using a 14-megahertz linear-array transducer after the
           initial enrollment and every six months later. Digital analysis of the images will be
           carried by a member expert in computer science.

        2. Evaluation of clinical manifestations:

           Evaluation of clinical manifestations includes measurement of side difference of angles
           in bilateral neck lateral flexion, rotation and habitual head position will performed
           using an arthrodial protractor by a trained member at the beginning of physical therapy
           and one month later, then every 2-3 months. Each measurement will be repeated 3 times to
           get the mean value. All cases will be followed for 1 and a half years, however, if the
           symptoms got completely recovery (the neck range of motion and position completely equal
           to sound side) or any complications resulting from the evaluation, the evaluation will
           be stopped.

        3. Evaluation of influence of rehabilitation effect:

      The parents will be inquired by a questionnaire one month later and then every 2-3 months to
      realize the treatment effect of the wry neck. The duration and frequency of massage and
      stretch programs by the therapist or the family or the other methods to treat the problem
      like wearing a neck collar, proper positioning… etc will be included in the semi-quantitative
      questionnaire.

      Data Analysis:

      Some representative image features will be expected to be computed from the SCM ultrasonic
      images. These features include area, both max and min Feret's diameters, and brightness of
      echogenicity in the region of interest. The ultrasonic image of the affected side would be
      compared with that of the sound side from their corresponding texture features. The Pearson's
      correlation will be performed to analyze the relevance of quantitative side differences of
      texture features in ultrasonography and clinical manifestations including side differences of
      neck rotation, lateral flexion and habitual head position between lesion sides and sound
      sides. Linear regression will be also used to adjust the influence of the treatment effect.
observational model: Case-Only
time perspective: Cross-Sectional
measure: cervical passive range of motion
time frame: From the date of beginning of physical therapy until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.
description: Measurement with an arthrodial protractor by a trained physiotherapist at the beginning of physical therapy and one month later, then every 2-3 months. Each measurement will be repeated 3 times to get the mean value.. All cases will be followed for 1 and a half years, however, if the symptoms got completely recovery (the neck range of motion and position completely equal to sound side) or any complications resulting from the evaluation, the evaluation will be stopped.
measure: Area in cm^2
time frame: From the date of initial enrollment until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.
description: Ultrasonography which contains both sides of the sternocleidomastoid muscle in transverse and longitudinal view for comparison of lesion side and sound side will be performed by expert physicians using a 14-megahertz linear-array transducer after the initial enrollment and every six months later. Digital analysis of the images will be carried by a member expert in computer science. The area was measured in pixels on the original image. Thus, dividing by the pixels of one square centimeter on each sonogram, the unit of the area was converted to square centimeter.
measure: Brightness of echogenicity in %
time frame: From the date of initial enrollment until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.
description: Ultrasonography which contains both sides of the sternocleidomastoid muscle in transverse and longitudinal view for comparison of lesion side and sound side will be performed by expert physicians using a 14-megahertz linear-array transducer after the initial enrollment and every six months later. Digital analysis of the images will be carried by a member expert in computer science. The sonograms were grayscale images, and the mean gray value was measured from 0 to 255 in the image analysis software where zero was designated black and 255 was designated white. Therefore, the mean gray value was divided by 255 and then converted to a percentage. In this study, zero percent was designated black, and 100% was designated white and indicated the brightness of the echogenicity on the sonogram.
measure: max Feret's diameter in cm
time frame: From the date of initial enrollment until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.
description: Ultrasonography which contains both sides of the sternocleidomastoid muscle in transverse and longitudinal view for comparison of lesion side and sound side will be performed by expert physicians using a 14-megahertz linear-array transducer after the initial enrollment and every six months later. Digital analysis of the images will be carried by a member expert in computer science. The max Feret's diameter was measured in pixels on the original image. Thus, dividing by the pixels of one centimeter on each sonogram, the unit of the max Feret's diameter was converted to centimeter.
measure: min Feret's diameter in cm
time frame: From the date of initial enrollment until the date of wryneck condition resolved or date of any complications resulting from the evaluation, whichever came first, assessed up to 18 months.
description: Ultrasonography which contains both sides of the sternocleidomastoid muscle in transverse and longitudinal view for comparison of lesion side and sound side will be performed by expert physicians using a 14-megahertz linear-array transducer after the initial enrollment and every six months later. Digital analysis of the images will be carried by a member expert in computer science. The min Feret's diameter was measured in pixels on the original image. Thus, dividing by the pixels of one centimeter on each sonogram, the unit of the min Feret's diameter was converted to centimeter.
arm group label: Wryneck
description: those with a condition
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Months
healthy volunteers: No
last name: Chu-Hsu Lin, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
citation: Cheng JC, Tang SP, Chen TM, Wong MW, Wong EM. The clinical presentation and outcome of treatment of congenital muscular torticollis in infants--a study of 1,086 cases. J Pediatr Surg. 2000 Jul;35(7):1091-6. doi: 10.1053/jpsu.2000.7833.
PMID: 10917303
citation: Canale ST, Griffin DW, Hubbard CN. Congenital muscular torticollis. A long-term follow-up. J Bone Joint Surg Am. 1982 Jul;64(6):810-6.
PMID: 7085709
citation: Hollier L, Kim J, Grayson BH, McCarthy JG. Congenital muscular torticollis and the associated craniofacial changes. Plast Reconstr Surg. 2000 Mar;105(3):827-35. doi: 10.1097/00006534-200003000-00001. No abstract available.
PMID: 10724239
citation: Cheng JC, Wong MW, Tang SP, Chen TM, Shum SL, Wong EM. Clinical determinants of the outcome of manual stretching in the treatment of congenital muscular torticollis in infants. A prospective study of eight hundred and twenty-one cases. J Bone Joint Surg Am. 2001 May;83(5):679-87. doi: 10.2106/00004623-200105000-00006.
PMID: 11379737
citation: Clarren SK, Smith DW, Hanson JW. Helmet treatment for plagiocephaly and congenital muscular torticollis. J Pediatr. 1979 Jan;94(1):43-6. doi: 10.1016/s0022-3476(79)80347-9.
PMID: 758420
citation: Cheng JC, Au AW. Infantile torticollis: a review of 624 cases. J Pediatr Orthop. 1994 Nov-Dec;14(6):802-8.
PMID: 7814599
citation: Dunn PM. Congenital postural deformities. Br Med Bull. 1976 Jan;32(1):71-6. doi: 10.1093/oxfordjournals.bmb.a071327. No abstract available.
PMID: 130955
citation: Ling CM, Low YS. Sternomastoid tumor and muscular torticollis. Clin Orthop Relat Res. 1972 Jul-Aug;86:144-50. doi: 10.1097/00003086-197207000-00020. No abstract available.
PMID: 5065412
citation: Davids JR, Wenger DR, Mubarak SJ. Congenital muscular torticollis: sequela of intrauterine or perinatal compartment syndrome. J Pediatr Orthop. 1993 Mar-Apr;13(2):141-7.
PMID: 8459000
citation: Tang S, Liu Z, Quan X, Qin J, Zhang D. Sternocleidomastoid pseudotumor of infants and congenital muscular torticollis: fine-structure research. J Pediatr Orthop. 1998 Mar-Apr;18(2):214-8.
PMID: 9531404
citation: Tang SF, Hsu KH, Wong AM, Hsu CC, Chang CH. Longitudinal followup study of ultrasonography in congenital muscular torticollis. Clin Orthop Relat Res. 2002 Oct;(403):179-85. doi: 10.1097/00003086-200210000-00026.
PMID: 12360024
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Chu-Hsu Lin
investigator title: Principal Investigator
mesh term: Torticollis
sharing ipd: No