Digital Analysis of Ultrasonographic Images in Children With Wry Neck

NCT03266224 | Completed

• 1 other identifier: 100-3793A3
• Study Type: observational
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Torticollis Congenital; Wryneck

Keywords

congenital muscular torticollis; wryneck; sternocleidomastoid; ultrasonography; digital analysis

Outcome Measures

Primary Outcomes (1)

• cervical passive range of motion

  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.

  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.

Secondary Outcomes (4)

• Area in cm^2

  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.

• Brightness of echogenicity in %

  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.

• max Feret's diameter in cm

  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.

• min Feret's diameter in cm

  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.

Study Arms (1)

Wryneck

those with a condition

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• infants with congenital muscular torticollis and
• age \<12 months at diagnosis

You may not qualify if:

• (1) wryneck caused by other known problems, including strabismus, trauma, neurogenic problems, congenital malformation, or bony deformity (e.g., hemivertebrae of the cervical spine)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cheng JC, Au AW. Infantile torticollis: a review of 624 cases. J Pediatr Orthop. 1994 Nov-Dec;14(6):802-8.

  PMID: 7814599 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Congenital torticollis; Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chu-Hsu Lin, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 30, 2017
• Study Start: April 30, 2013
• Primary Completion: August 15, 2015
• Study Completion: August 15, 2015
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share