A randomised controlled trial comparing gradual vs. immediate removal of orthosis following clinical union of traumatic cervical spinal injuries

A randomised controlled trial comparing gradual vs. immediate removal or orthosis following clinical union of traumatic cervical spinal injuries in relation to activity limitation and participation restriction measures.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000230853

Acronym

nil

Enrollment

Registered

2012-02-23

Start date

2012-03-31

Completion date

2015-03-01

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To investigate the practice of removal of orthosis in patients with cervical trauma at time of clinical union in relation to patients perception of pain, their activity limitation and participation restriction measures

Interventions

Gradual vs. immediate removal of orthosis at time of clinical union when orthosis ready to be removed. Gradual removal of orthosis is instruction to wear the orthosis out of the house or when performing vulnerable activities (eg playing with grandchildren, doing home duties) and remove it when at home and overnight as pain permits. Patients will be encouraged to increase time out of orthosis by 2 hours each day until complete withdrawal by up to 2 weeks. This was the protocol surveyed by The Alfred trauma surgeons to be the most common used. Patient will record daily usage via diary. The immediate removal of orthosis group will have orthosis removed immediately at time of clinical union and they will be given strategies to reduce pain.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

-males and females at 18 years of age and over with cervical spinal trauma who are immobilised in an orthosis -ability to read and write English -eligible participants shall be deemed healthy

Exclusion criteria

-age and English barrier as outlined above -multitrauma shall be excluded

Outcome results