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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] 280475 0
Nil
Universal Trial Number (UTN)
U1111-1130-6944
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 286453 0
Condition category
Condition code
Musculoskeletal 286711 286711 0 0
Other muscular and skeletal disorders
Public Health 286763 286763 0 0
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] 284837 0
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] 287103 0
Clinician response to
"Would you provide subacromial injection today?"
Timepoint [1] 287103 0
on completion of patient assessment
Primary outcome [2] 287104 0
Shoulder Pain and Disability Index (SPADI)
Timepoint [2] 287104 0
Baseline, 6 and 12 weeks post injection
Secondary outcome [1] 297380 0
Clinician response to
"Is it safe to offer subacromial injection today?"
Timepoint [1] 297380 0
on completion of patient assessment
Secondary outcome [2] 297381 0
waiting time for first appointment to an Orthopaedic clinic in the Gold Coast Health Service District, taken from the orthopaedic waiting list.
Timepoint [2] 297381 0
at time of intervention
Secondary outcome [3] 297382 0
staff costs, taken from standard pay scales
Timepoint [3] 297382 0
12 weeks post injection
Secondary outcome [4] 297383 0
Quality of Life: EuroQual-5D-5L
Timepoint [4] 297383 0
Baseline, 6 and 12 weeks post injection
Secondary outcome [5] 297384 0
10 cm Visual Analogue Scale (VAS) patient perception of pain over past 3 days
Timepoint [5] 297384 0
Baseline, 6 and 12 weeks post injection
Secondary outcome [6] 297385 0
Self-rated Global Rating of Change Scale
Timepoint [6] 297385 0
6 and 12 weeks post injection
Secondary outcome [7] 297386 0
10 cm Visual Analogue Scale (VAS) patient satisfaction with care
Timepoint [7] 297386 0
12 weeks post injection
Secondary outcome [8] 307294 0
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] 307294 0
baseline
Secondary outcome [9] 307295 0
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] 307295 0
'immediately pre and post injection'
Secondary outcome [10] 307296 0
Post injection physiotherapy sessions. The number of post injection physiotherapy sessions received by each participant will be gathered from hospital records
Timepoint [10] 307296 0
12 weeks
Secondary outcome [11] 307297 0
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] 307297 0
From the time of injection until the final outcome at week 12
Secondary outcome [12] 307298 0
Impact and Costs questionnaire
Timepoint [12] 307298 0
baseline
Secondary outcome [13] 307299 0
Work Limitations Questionnaire
Timepoint [13] 307299 0
Baseline
Secondary outcome [14] 307300 0
Work Productivity and Activity Impairment Questionnaire
Timepoint [14] 307300 0
Baseline
Secondary outcome [15] 307301 0
Change in medications used.
Medications used by participants will be recorded.
Timepoint [15] 307301 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
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] 285249 0
Government body
Name [1] 285249 0
Allied Health Workforce & Coordination Unit
Address [1] 285249 0
Level 6 Queensland Health Building
147-163 Charlotte Street
Brisbane QLD 4000
Country [1] 285249 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Health Service District
Address
Nerang St
Southport
QLD 4215
Country
Australia
Secondary sponsor category [1] 284111 0
Individual
Name [1] 284111 0
Darryn Marks
Address [1] 284111 0
Physiotherapy Dept
Gold Coast Hospital
Nerang St
Southport
QLD 4215
Country [1] 284111 0
Australia
Other collaborator category [1] 260799 0
University
Name [1] 260799 0
Griffith University
Address [1] 260799 0
Gold Coast Campus
QLD 4222
Country [1] 260799 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287241 0
Gold Coast Health Service District
Ethics committee address [1] 287241 0
8 Little High Street, Southport Qld 4215
Ethics committee country [1] 287241 0
Australia
Date submitted for ethics approval [1] 287241 0
Approval date [1] 287241 0
24/04/2012
Ethics approval number [1] 287241 0
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 34166 0
Mr Darryn Marks
Address 34166 0
Physiotherapist
Allied Health
Gold Coast University Hospital
Hospital Blvd
Southport
QLD
4215
Country 34166 0
Australia
Phone 34166 0
+61 756873120
Fax 34166 0
Email 34166 0
darryn_marks@health.qld.gov.au
Contact person for public queries
Name 17413 0
Mr Darryn Marks
Address 17413 0
Physiotherapist
Allied Health
Gold Coast University Hospital
Hospital Blvd
Southport
QLD
4215
Country 17413 0
Australia
Phone 17413 0
+61 756873120
Fax 17413 0
Email 17413 0
darryn_marks@health.qld.gov.au
Contact person for scientific queries
Name 8341 0
Mr Darryn Marks
Address 8341 0
Physiotherapist
Allied Health
Gold Coast University Hospital
Hospital Blvd
Southport
QLD
4215
Country 8341 0
Australia
Phone 8341 0
+61 756873120
Fax 8341 0
Email 8341 0
darryn_marks@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary