Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001183976
Ethics application status
Approved
Date submitted
14/11/2011
Date registered
15/11/2011
Date last updated
10/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial on the effect of Physiotherapy and an external rotation brace in the management of first time anterior shoulder dislocations in patients aged 15-40 years.
Scientific title
A randomised controlled trial on the effect of Physiotherapy and an external rotation brace on redislocation rate and shoulder function in patients aged 15-40 years with a first time anterior shoulder dislocation.
Secondary ID [1] 273387 0
Nil
Universal Trial Number (UTN)
U1111-1125-8189
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Anterior Shoulder Dislocation 279164 0
Condition category
Condition code
Musculoskeletal 279358 279358 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 279365 279365 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be immobilised in a shoulder external rotation brace and will be advised to wear the brace continuously for three weeks, except during showering. Participants randomised to this group will receive a supervised physiotherapy program consisting of graduated shoulder range of motion and strengthening exercises. The physiotherapy sessions will be approximately 30 minutes in duration. Participants will receive physiotherapy one week and 3 weeks post initial examination and then every week until 6 weeks post dislocation. They will then receive physiotherapy every 2 weeks until 3 months post dislocation. Therefore, they will receive a total of nine physiotherapy sessions over a 12 week period.
Intervention code [1] 283717 0
Treatment: Other
Intervention code [2] 283724 0
Rehabilitation
Comparator / control treatment
All participants will be immobilised in a shoulder external rotation brace and will be advised to wear the brace continuously for three weeks, except during showering.
Participants randomised to this group will receive a supervised physiotherapy program consisting of graduated range of motion exercises, pulsed ultrasound (US) and massage. The physiotherapy sessions will be approximately 30 minutes in duration. Participants will receive physiotherapy one week and 3 weeks post initial examination and then every week until 6 weeks post dislocation. They will then receive physiotherapy every 2 weeks until 3 months post dislocation. Therefore, they will receive a total of seven physiotherapy sessions over a 12 week period.
Control group
Active

Outcomes
Primary outcome [1] 285949 0
Redislocation assessed by questioning at patient follow-up. May also include clinical diagnosis by xray.
Timepoint [1] 285949 0
6 weeks, 3months, 12 months and 2 years
Secondary outcome [1] 294828 0
Shoulder function as measured by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Timepoint [1] 294828 0
6 weeks, 3months, 12 months and 2 years
Secondary outcome [2] 294829 0
Shoulder Function as measured by The Oxford Shoulder Instability Index (OSI) questionnaire
Timepoint [2] 294829 0
6 weeks, 3months, 12 months and 2 years

Eligibility
Key inclusion criteria
Volunteers will be included in the study if they are aged over 15 years and have a clinical and radiographic diagnosis of an initial anterior shoulder dislocation caused by a traumatic event and presented within three days after the dislocation.
Minimum age
15 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Volunteers will be excluded if they have: i) a previous history of shoulder dislocations; ii) a history of shoulder surgery; iii) a history of shoulder fracture; iv) undergone physiotherapy or injection therapy to their affected shoulder within the last 6 months; v) neurological involvement (e.g. associated brachial plexus injury); vi) a co-existing systemic condition, severe medical condition, inflammatory or neurological condition; or vii) cognitive difficulties.

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)
Subjects are allocated by the treating physiotherapist via a computerised randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/01/2012
Actual
3/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284199 0
Hospital
Name [1] 284199 0
Gold Coast University Hospital
Country [1] 284199 0
Australia
Funding source category [2] 284200 0
Other Collaborative groups
Name [2] 284200 0
Gold Coast Hospital Foundation and Griffith University Research Gracnt
Country [2] 284200 0
Australia
Funding source category [3] 284201 0
Government body
Name [3] 284201 0
Queensland Health - Health Practitioner Research Grant
Country [3] 284201 0
Australia
Primary sponsor type
Individual
Name
Timothy Walker
Address
Physiotherapy Department
Gold Coast University Hospital
Hospital Blvd
Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 269160 0
None
Name [1] 269160 0
Address [1] 269160 0
Country [1] 269160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286169 0
Gold Coast Health Service District Human Research Ethics Committee
Ethics committee address [1] 286169 0
Ethics committee country [1] 286169 0
Date submitted for ethics approval [1] 286169 0
Approval date [1] 286169 0
Ethics approval number [1] 286169 0
HREC/11/QGC/67

Summary
Brief summary
This project will be the first high quality clinical trial comparing two conservative physiotherapy management approaches for anterior shoulder dislocations (ASDs) using reliable measures of shoulder function and re-dislocation as outcomes. This project will also contribute to the research in immobilisation positioning for patients with ASD and will provide further direction on the implications of conservative management versus surgical intervention for this population.
The incidence of ASD has been estimated at approximately 1.7% of the population and the consequences of traumatic shoulder dislocation and re-dislocation include loss of work productivity, ongoing loss and limitation of shoulder function and sporting activities, and degenerative arthropathy, all contributing to great cost for the patient and community.
The findings of this project will benefit patients, orthopaedic specialists, emergency department specialists, general practitioners and allied health personnel who deal with this frequently seen condition and consequently reduce the significant costs associated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33388 0
Mr Timothy Walker
Address 33388 0
Physiotherapy Department
Gold Coast University Hospital
Hospital Blvd
Southport, QLD 4215
Country 33388 0
Australia
Phone 33388 0
+61 7 56872929
Fax 33388 0
Email 33388 0
Timothy.Walker@health.qld.gov.au
Contact person for public queries
Name 16635 0
Timothy Walker
Address 16635 0
Gold Coast University Hospital
Hospital Blvd
Southport, QLD 4215
Country 16635 0
Australia
Phone 16635 0
+61 7 56872929
Fax 16635 0
Email 16635 0
Timothy_Walker@health.qld.gov.au
Contact person for scientific queries
Name 7563 0
Timothy Walker
Address 7563 0
Gold Coast University Hospital
Hospital Blvd
Southport , QLD, 4215
Country 7563 0
Australia
Phone 7563 0
+610755198460
Fax 7563 0
Email 7563 0
Timothy_Walker@health.qld.gov.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseConservative management following closed reduction of traumatic anterior dislocation of the shoulder(Review).2019https://dx.doi.org/10.1002/14651858.CD004962.pub4.
N.B. These documents automatically identified may not have been verified by the study sponsor.