ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000532808

Ethics application status

Approved

Date submitted

17/05/2012

Date registered

21/05/2012

Date last updated

4/11/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1130-6944

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

shoulder pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Usual care - 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 an Orthopaedic Surgeon. Usual follow up care involving a course of physiotherapy on a case to case basis.

Control group

Active

Outcomes

Primary outcome [1]

Clinician response to
"Would you provide subacromial injection today?"

Timepoint [1]

on completion of patient assessment

Primary outcome [2]

Shoulder Pain and Disability Index (SPADI)

Timepoint [2]

Baseline, 6 and 12 weeks post injection

Secondary outcome [1]

Clinician response to
"Is it safe to offer subacromial injection today?"

Timepoint [1]

on completion of patient assessment

Secondary outcome [2]

waiting time for first appointment to an Orthopaedic clinic in the Gold Coast Health Service District, taken from the orthopaedic waiting list.

Timepoint [2]

at time of intervention

Secondary outcome [3]

staff costs, taken from standard pay scales

Timepoint [3]

12 weeks post injection

Secondary outcome [4]

Quality of Life: EuroQual-5D-5L

Timepoint [4]

Baseline, 6 and 12 weeks post injection

Secondary outcome [5]

10 cm Visual Analogue Scale (VAS) patient perception of pain over past 3 days

Timepoint [5]

Baseline, 6 and 12 weeks post injection

Secondary outcome [6]

Self-rated Global Rating of Change Scale

Timepoint [6]

6 and 12 weeks post injection

Secondary outcome [7]

10 cm Visual Analogue Scale (VAS) patient satisfaction with care

Timepoint [7]

12 weeks post injection

Secondary outcome [8]

Clinical assessment findings from each clinician. Recorded by each clinician on standardised assessment forms including clinical findings (eg Range of movement, response to orthopaedic shoulder tests, neurological findings) diagnosis and treatment plan.

Timepoint [8]

baseline

Secondary outcome [9]

ROM / pain immediately pre and post injection. Shoulder ROM in scapula plane measured with a goniometer, 100mm VAS of pain anchored by no pain and worse pain imaginable.

Timepoint [9]

'immediately pre and post injection'

Secondary outcome [10]

Post injection physiotherapy sessions. The number of post injection physiotherapy sessions received by each participant will be gathered from hospital records

Timepoint [10]

12 weeks

Secondary outcome [11]

Adverse events.
Participants will be instructed to report adverse events. Serious adverse events are defined as requiring hospitalisation, causing persistent incapacity or antibiotic treatment of infection related to the injection.

Timepoint [11]

From the time of injection until the final outcome at week 12

Secondary outcome [12]

Impact and Costs questionnaire

Timepoint [12]

baseline

Secondary outcome [13]

Work Limitations Questionnaire

Timepoint [13]

Baseline

Secondary outcome [14]

Work Productivity and Activity Impairment Questionnaire

Timepoint [14]

Baseline

Secondary outcome [15]

Change in medications used.
Medications used by participants will be recorded.

Timepoint [15]

baseline and at 12 weeks

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

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)

All participants will be examined once by the physiotherapist and once by the orthoapedic surgeon.

Participants entering stage 2 (intervention) will be randomised to receive a subacromial injection from
either the physiotherapist or surgeon.

The sequence will be stratified by source of the patients (i.e. Orthopaedic Physiotherapy Screening Clinic waiting list versus general orthopaedic waiting list). The randomisation sequence will be concealed in sealed opaque envelopes and administered by the Research Assistant.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer generated (excel software) random number sequence will be used to randomise the order of treating clinicians.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/07/2012

Actual

14/01/2013

Date of last participant enrolment

Anticipated

Actual

2/06/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Allied Health Workforce & Coordination Unit

Address [1]

Level 6 Queensland Health Building
147-163 Charlotte Street
Brisbane QLD 4000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Gold Coast Health Service District

Address

Nerang St
Southport
QLD 4215

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Darryn Marks

Address [1]

Physiotherapy Dept
Gold Coast Hospital
Nerang St
Southport
QLD 4215

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Griffith University

Address [1]

Gold Coast Campus
QLD 4222

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Health Service District

Ethics committee address [1]

8 Little High Street, Southport Qld 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/04/2012

Ethics approval number [1]

HREC/12/QGC/30

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Darryn Marks

Address

Physiotherapist
Allied Health
Gold Coast University Hospital
Hospital Blvd
Southport
QLD
4215

Country

Australia

Phone

+61 756873120

Fax

[email protected]

Contact person for public queries

Name

Darryn Marks

Address

Physiotherapist
Allied Health
Gold Coast University Hospital
Hospital Blvd
Southport
QLD
4215

Country

Australia

Phone

+61 756873120

Fax

[email protected]

Contact person for scientific queries

Name

Darryn Marks

Address

Physiotherapist
Allied Health
Gold Coast University Hospital
Hospital Blvd
Southport
QLD
4215

Country

Australia

Phone

+61 756873120

Fax

[email protected]

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	An experienced physiotherapist prescribing and administering corticosteroid and local anaesthetic injections to the shoulder in an Australian orthopaedic service, a non-inferiority randomised controlled trial and economic analysis: Study protocol for a randomised controlled trial.	2014	https://dx.doi.org/10.1186/1745-6215-15-503
Embase	Agreement between a physiotherapist and an orthopaedic surgeon regarding management and prescription of corticosteroid injection for patients with shoulder pain.	2016	https://dx.doi.org/10.1016/j.math.2016.10.001
Embase	Increasing capacity for the treatment of common musculoskeletal problems: A non-inferiority RCT and economic analysis of corticosteroid injection for shoulder pain comparing a physiotherapist and orthopaedic surgeon.	2016	https://dx.doi.org/10.1371/journal.pone.0162679
Embase	Immediate response to injection is associated with conservative care outcomes at 12 weeks in subacromial shoulder pain.	2023	https://dx.doi.org/10.1016/j.msksp.2023.102726

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

Trial Review

Documents added manually

Documents added automatically