Torticollis in infants due to suboccipital strain: a pilot study
| ISRCTN | ISRCTN10734062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10734062 |
| Secondary identifying numbers | 2679035 |
- 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
Scientific
Akershus Universitetssykehus
Sykehusveien 27
Lørenskog
1478
Norway
| Phone | +47 67 92 83 40 |
|---|---|
| elsebeth.haugen@ahus.no |
Study information
| Study design | A randomised, single blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 02/05/2007 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | 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
1478
Norway
Sponsor information
Akershus University Hospital (Akershus Universitetssykehus) (Norway)
Hospital/treatment centre
Hospital/treatment centre
Forskningsadministrativ enhet
Sykehusveien 27
Lørenskog
1478
Norway
| Phone | +47 67 92 79 14 |
|---|---|
| tone.kjefsoy@ahus.no | |
| Website | http://www.ahus.no/ |
"ROR" |
https://ror.org/0331wat71 |
Funders
Funder type
Hospital/treatment centre
Strategic Research Funds of Akershus University Hospital (Strategiske forskningsmidler ved Akershus Universitetssykehus) (Norway)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
