Torticollis in infants due to suboccipital strain: a pilot study

ISRCTN	ISRCTN10734062
DOI	https://doi.org/10.1186/ISRCTN10734062
Protocol serial number	2679035
Sponsor	Akershus University Hospital (Akershus Universitetssykehus) (Norway)
Funder	Strategic Research Funds of Akershus University Hospital (Strategiske forskningsmidler ved Akershus Universitetssykehus) (Norway)

Submission date: 05/07/2007
Registration date: 16/10/2007
Last edited: 15/07/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Else Beth Haugen
Scientific

Akershus Universitetssykehus
Sykehusveien 27
Lørenskog
1478
Norway

Phone	+47 67 92 83 40
Email	elsebeth.haugen@ahus.no

Study information

Primary study design	Interventional
Study design	A randomised, single blinded controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Torticollis in infants due to suboccipital strain: a pilot study
Study objectives	The movement patterns of the neck in infants with torticollis treated with manual therapy in addition to child physiotherapy is normalising more rapidly than in infants treated with child physiotherapy alone.
Ethics approval(s)	Approval received from the Regional Committee of Medicine Science Ethics, Southern Norway (Regional komite for medisinsk forskningsetikk Sor-Norge) on the 2nd May 2007 (ref: S-07104a).
Health condition(s) or problem(s) studied	Torticollis in infancy
Intervention	Group 1: receives manual therapy once or twice in addition to child physiotherapy. Manual therapy will take place at the first visit, and then again in four weeks time if necessary. Group 2: receives child physiotherapy only. Child physiotherapy will take place before, during and after the trial period. How often this takes place will be decided by what the child needs.
Intervention type	Other
Primary outcome measure(s)	Each infant is videotaped three times during the study period of eight weeks. The films are assessed by three child physiotherapists and scored individually into five different categories due to the seriousness of the torticollis. Primary and secondary outcomes will be measured at the first visit, after 2 weeks and at last after 8 weeks. The randomisation then ends and both groups can get manual therapy if it is needed.
Key secondary outcome measure(s)	1. Active range of movement of the neck 2. Compensations during active rotation of the neck 3. Passive range of movement of the neck (rotation, lateral and ventral flexion) 4. Signs of pain when passive range of movement is tested 5. Antigravity movement of the neck during lateral tilting of the infant 6. Anamnestic information 7. Questionnaire: this questionnaire is in Norwegian, and consists of seven questions with a Visual Analog Scale line Primary and secondary outcomes will be measured at the first visit, after 2 weeks and at last after 8 weeks. The randomisation then ends and both groups can get manual therapy if it is needed.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	6 Months
Sex	All
Target sample size at registration	30
Total final enrolment	32
Key inclusion criteria	1. Infants with torticollis, aged 3 - 6 months 2. Active and passive range of movement of the neck must be restricted
Key exclusion criteria	1. Serious pathology - somatic and cognitive 2. Syndromes 3. Intermittent torticollis
Date of first enrolment	02/05/2007
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Norway

Study participating centre

Akershus Universitetssykehus

Lørenskog
1478
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2011	15/07/2021	Yes	No

Editorial Notes

15/07/2021: Publication reference and total final enrolment added.