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Trial registered on ANZCTR


Registration number
ACTRN12612000230853
Ethics application status
Approved
Date submitted
14/02/2012
Date registered
23/02/2012
Date last updated
8/04/2021
Date data sharing statement initially provided
8/04/2021
Date results provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing gradual vs. immediate removal of orthosis following clinical union of traumatic cervical spinal injuries
Scientific title
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.
Secondary ID [1] 279939 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical spinal trauma including fractures and ligamentous injuries 285849 0
Condition category
Condition code
Injuries and Accidents 286028 286028 0 0
Fractures
Musculoskeletal 286119 286119 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284262 0
Treatment: Devices
Comparator / control treatment
Gradual vs. immediate removal of orthosis as outlined above. Control group is the group that are randomised to immediate removal of orthosis. The difference is timing comparison where immediate removal of orthosis at time of clinical union is compared to gradual removal which will be the documented hours over 2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 286520 0
Neck Disability Index (NDI)
Timepoint [1] 286520 0
-at baseline (at time of clinical union), at 2 weeks following clinical union and 6 weeks following clinical union
Secondary outcome [1] 296071 0
-11 point Numerical Pain Rating Scale ((NPRS)
Timepoint [1] 296071 0
-daily diary recording up to 6 weeks following clinical union
Secondary outcome [2] 296072 0
-use of opioid analgesia
Timepoint [2] 296072 0
-daily diary recording up to 6 weeks following clinical union
Secondary outcome [3] 296073 0
-the Short Form 12-item survey questionnaire(SF-12)
Timepoint [3] 296073 0
-at baseline,2 weeks and 6 weeks following clinical union
Secondary outcome [4] 296078 0
-The Fear Avoidance Beliefs (FAB) Questionnaire
Timepoint [4] 296078 0
-at baseline, 2 weeks and 6 weeks following clinical union

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-age and English barrier as outlined above
-multitrauma shall be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible patients will be recruited by a research nurse after diagnosis of clinical union of injury. A research nurse shall explain trial and seek informed written consent from the patient. Once consent is obtained, the independent examination (independent examiner) shall take place prior to randomisation being allocated via concealed method with usage of opaque envelopes (research nurse).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by computer generated block randomisation and placed in opaque envelopes. Allocation will be concealed until informed consent is obtained and baseline assessment completed. Randomisation will occur either into protocol A(immediate removal of orthosis) or protocol B (gradual removal of orthosis)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2012
Actual
31/03/2012
Date of last participant enrolment
Anticipated
Actual
1/03/2015
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
80
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19072 0
The Alfred - Prahran
Recruitment postcode(s) [1] 33622 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 284709 0
Hospital
Name [1] 284709 0
Alfred Health Special Projects Grant 2012
Country [1] 284709 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
PO Box 315
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 283608 0
None
Name [1] 283608 0
Address [1] 283608 0
Country [1] 283608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286712 0
Alfred Health Hospital and Research Ethics Committee approval
Ethics committee address [1] 286712 0
Ethics committee country [1] 286712 0
Australia
Date submitted for ethics approval [1] 286712 0
20/02/2012
Approval date [1] 286712 0
30/03/2012
Ethics approval number [1] 286712 0
Project 75/12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33774 0
Miss Jennifer Maciel
Address 33774 0
Alfred Hospital
55 Commercial Rd
PO Box 315 Prahran
Victoria 3181
Country 33774 0
Australia
Phone 33774 0
+61 03 90763450
Fax 33774 0
+61, 03, 90765430
Email 33774 0
J.Maciel@alfred.org.au
Contact person for public queries
Name 17021 0
Jennifer Maciel
Address 17021 0
c/o Physiotherapy Department
PO Box 315
Prahran VIC 3181
Country 17021 0
Australia
Phone 17021 0
61 3 90763450
Fax 17021 0
61 3 90762702
Email 17021 0
J.Maciel@alfred.org.au
Contact person for scientific queries
Name 7949 0
Jennifer Maciel
Address 7949 0
PO Box 315
Prahran VIC 3181
Country 7949 0
Australia
Phone 7949 0
61 3 90763450
Fax 7949 0
61 3 90762702
Email 7949 0
J.Maciel@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.