Contact information
Type
Scientific
Primary contact
Mrs Else Beth Haugen
ORCID ID
Contact details
Akershus Universitetssykehus
Sykehusveien 27
Lørenskog
1478
Norway
+47 67 92 83 40
elsebeth.haugen@ahus.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2679035
Study information
Scientific title
Acronym
Study hypothesis
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
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).
Study design
A randomised, single blinded controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
02/05/2007
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Infants with torticollis, aged 3 - 6 months
2. Active and passive range of movement of the neck must be restricted
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Serious pathology - somatic and cognitive
2. Syndromes
3. Intermittent torticollis
Recruitment start date
02/05/2007
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Norway
Trial participating centre
Akershus Universitetssykehus
Lørenskog
1478
Norway
Sponsor information
Organisation
Akershus University Hospital (Akershus Universitetssykehus) (Norway)
Sponsor details
Forskningsadministrativ enhet
Sykehusveien 27
Lørenskog
1478
Norway
+47 67 92 79 14
tone.kjefsoy@ahus.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Strategic Research Funds of Akershus University Hospital (Strategiske forskningsmidler ved Akershus Universitetssykehus) (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary