Bipolar Surgical Release in Congenital Muscular Torticollis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03562260
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : July 2, 2018
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
The congenital muscular torticollis is common disease in children.The indication for surgery is the children have persist deformity after 1 year old.Many surgical treatment had proposed such as unipolar release and bipolar release.By author experience the bipolar release had better results from complete cut the muscle both origin and insertion.This study wants to study the results of treatment in term of recurrence of the deformity.

Condition or disease Intervention/treatment Phase
Congenital Muscular Torticollis Procedure: bipolar release Not Applicable

Detailed Description:
the study perform in children with congenital muscular torticollis

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: only 1 group in children who received the bipolar release
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Result of Bipolar Surgical Release in Congenital Muscular Torticollis
Estimated Study Start Date : August 10, 2018
Estimated Primary Completion Date : August 9, 2019
Estimated Study Completion Date : August 9, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: children who had bipolar release
children who had bipolar release are included
Procedure: bipolar release
the bipolar release is the surgery that cut the origin and insertion of the sternocleidomastoid muscle that cause the torticollis from its contracture

Primary Outcome Measures :
  1. ImageJ scoring system [ Time Frame: no torticollis after 1 year of surgery ]
    measurement from pictures of head and face compared to normal children score 1-3 in 5 measurement in total score of 15 as interval scale score has 4 grade 13-15 is excellent results score 10-12 good result 7-9 fair less than 6 score is poor result after surgery

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 1. all children age ranged from 5-15 years old who received the surgical treatment by bipolar release in the hospital.

Exclusion Criteria:

  • 1. no history of surgery at the neck 2. no history of congenital anomalies and syndrome that effect the neck

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03562260

Contact: Prof.Dr.Kamolporn Kaewpornsawan, MD 660814984227

Prof.Dr.Kamolporn Kaewpornsawan Recruiting
Bangkok, Thailand, 10700
Contact: Prof.Dr.Kamolporn kaewpornsawan, MD.    (66)024197968 ext 127   
Sponsors and Collaborators
Mahidol University
Principal Investigator: Prof.Dr.Kamolporn Kaewpornsawan Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand

Responsible Party: Mahidol University Identifier: NCT03562260     History of Changes
Other Study ID Numbers: si049/2013
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no sharing IPD data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms