Condition category
Musculoskeletal Diseases
Date applied
05/07/2007
Date assigned
16/10/2007
Last edited
18/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ahus.no/

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

Publication citations

Additional files

Editorial Notes