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.

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001183976

Enrollment

200

Registered

2011-11-15

Start date

2012-11-03

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

15 Years to 40 Years

Healthy volunteers

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.

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.

Outcome results