ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

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]

Redislocation assessed by questioning at patient follow-up. May also include clinical diagnosis by xray.

Timepoint [1]

6 weeks, 3months, 12 months and 2 years

Secondary outcome [1]

Shoulder function as measured by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

Timepoint [1]

6 weeks, 3months, 12 months and 2 years

Secondary outcome [2]

Shoulder Function as measured by The Oxford Shoulder Instability Index (OSI) questionnaire

Timepoint [2]

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?

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]

Hospital

Name [1]

Gold Coast University Hospital

Address [1]

Gold Coast University Hospital
Hospital Blvd
Southport, QLD 4215

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Gold Coast Hospital Foundation and Griffith University Research Gracnt

Address [2]

Gold Coast Hospital Foundation
Gold Coast University Hospital
Hospital Blvd
Southport QLD 4215

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Queensland Health - Health Practitioner Research Grant

Address [3]

Allied Health Clinical Education and Training Unit
GPO Box 48
Brisbane QLD 4001

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Health Service District Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Mr Timothy Walker

Address

Physiotherapy Department
Gold Coast University Hospital
Hospital Blvd
Southport, QLD 4215

Country

Australia

Phone

+61 7 56872929

Fax

Timothy.Walker@health.qld.gov.au

Contact person for public queries

Name

Timothy Walker

Address

Gold Coast University Hospital
Hospital Blvd
Southport, QLD 4215

Country

Australia

Phone

+61 7 56872929

Fax

Timothy_Walker@health.qld.gov.au

Contact person for scientific queries

Name

Timothy Walker

Address

Gold Coast University Hospital
Hospital Blvd
Southport , QLD, 4215

Country

Australia

Phone

+610755198460

Fax

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

Source	Title	Year of Publication	DOI
Embase	Conservative management following closed reduction of traumatic anterior dislocation of the shoulder(Review).	2019	https://dx.doi.org/10.1002/14651858.CD004962.pub4.

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically