RecruitingACTRN12611001183976

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.


Sponsor

Timothy Walker

Enrollment

200 participants

Start Date

Nov 3, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 15 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is studying the best way to treat a first-time shoulder dislocation (when the ball of the shoulder joint slips out of its socket). It compares two non-surgical approaches: standard physiotherapy versus physiotherapy plus wearing a special brace that holds the arm rotated outward. The goal is to find out which approach works better in helping the shoulder heal properly and reducing the chance of it dislocating again. You may be eligible if: - You are aged 15 to 40 years old - You have had your first-ever anterior shoulder dislocation confirmed by X-ray - Your dislocation was caused by a traumatic injury - You are able to start treatment within 3 days of the dislocation You may NOT be eligible if: - You have had a previous shoulder dislocation before this one - You have had shoulder surgery or a shoulder fracture in the past - You have received physiotherapy or injections in that shoulder in the last 6 months - You have nerve damage related to the dislocation (such as a brachial plexus injury) - You have a serious medical or neurological condition - You have cognitive difficulties that would prevent participation Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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ACTRN12611001183976