An experienced physiotherapist prescribing and administering corticosteroid and local anaesthetic injections to the shoulder in an Australian orthopaedic service: a non-inferiority RCT.

A non-inferiority RCT comparing clinician decision making and patient reported outcomes when an experienced physiotherapist or an orthopaedic surgeon prescribes and administers corticosteroid injections for orthopaedic shoulder pain

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000532808

Enrollment

Registered

2012-05-21

Start date

2013-01-14

Completion date

2014-06-02

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

Corticosteroid and local anaesthetic injections (often called cortisone) are commonly used to treat shoulder pain. For over 10 years in the UK, physiotherapists with additional training in medicines and injecting, have been able to independently give these injections. UK services involving physiotherapist injecting have been found to be effective and help patients get appropriate care sooner. In Australia physiotherapists are not normally permitted to prescribe or inject. We want to see whether allowing an appropriately trained physiotherapist to give shoulder injections, would be feasible or beneficial for Gold Coast patients. We will use an experienced Australian physiotherapist who has completed the necessary prescribing and injecting training in the UK, has 5 years experience of giving these injections to patients in the UK and has undertaken a further period of supervised injection practice in Australia. Our research will compare this physiotherapist with a Specialist Orthopaedic Surgeon in relation to decisions about who should be offered an injection and responses to the injection.

Interventions

Delivery of a standard procedure by new profession: Patient assessment, selection and delivery of a single corticosteroid (Betamethasone 5.7mg or a substitute - Depomedrone) and local anaesthetic (Lidocaine 1%) injection to the subacromial space of the shoulder by a Physiotherapist. Usual follow up care involving a course of physiotherapy on a case to case basis.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Assessment Stage inclusion criteria: Volunteers aged 18 years and over with a new GP referral to orthopaedics for shoulder pain Treatment Stage inclusion criteria: Agreement between examiners on “would you provide subacromial injection today?” Participants who are able fill in the questionnaires and follow post-injection instructions

Exclusion criteria

Assessment Stage exclusion criteria: Previous consultation with either the research physiotherapist or the research orthopaedic surgeon for this condition No XRay of the shoulder in the past 12 months Treatment Stage exclusion criteria: Previous surgery to the involved shoulder Currently taking anticoagulant medication Need for prophylactic antibiotics with the injection Pregnancy or breastfeeding

Outcome results