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Trial registered on ANZCTR


Registration number
ACTRN12615000525583
Ethics application status
Approved
Date submitted
12/05/2015
Date registered
26/05/2015
Date last updated
29/11/2018
Date data sharing statement initially provided
29/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Physiotherapists prescribing medications to manage pain in emergency departments and outpatient clinics
Scientific title
In patients presenting to emergency departments or orthopaedic clinics with musculoskeletal conditions, does physiotherapists prescribing medications to manage pain result in adverse events?
Secondary ID [1] 286595 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal pain of spinal origin 294893 0
Peripheral musculoskeletal injuries / conditions / symptoms: sprains, strains, suspected simple fractures, subacute and chronic tendinitis, tendinosis, tenosynovitis, bursitis, tenovaginitis (trigger finger, DeQuervain’s) and osteoarthritic arthritic joint disease
 294894 0
Condition category
Condition code
Musculoskeletal 295138 295138 0 0
Other muscular and skeletal disorders
Injuries and Accidents 295375 295375 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 295376 295376 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment and management of patient presentation in accordance with clinical guidelines by physiotherapists in the emergency department or orthopaedic clinic. This may involve mobilisation, massage, exercise therapy, stretches, advice and provision of the following medications, at the discretion of the physiotherapist, for the management of pain:
Paracetamol (oral tablet)
Paracetamol and Codeine (oral tablet)
Diclofenac sodium (oral tablet)
Lignocaine 1 or 2% (subcutaneous or intra-articular injection)
Nitrous Oxide up to 70% (inhaled gas)
Ibuprofen (oral tablet)
Betamethasone injection 5.7mg/ml (intra-articular injection)
Methylprednisolone acetate 40mg/ml 1ml (intra-articular injection)
Amitriptyline hydrochloride (oral tablet)
Intervention code [1] 291715 0
Treatment: Drugs
Intervention code [2] 291716 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294903 0
Number of adverse events, measured as number of clinical incidents reported and related to the physiotherapist intervention
Timepoint [1] 294903 0
Within 1 month post intervention
Secondary outcome [1] 314313 0
Patient satisfaction as measured on a 5 point Likert Scale
Timepoint [1] 314313 0
Within one week of intervention
Secondary outcome [2] 314314 0
Staff satisfaction as measured on a 5 point Likert Scale
Timepoint [2] 314314 0
Within 6 months of trial commencement

Eligibility
Key inclusion criteria
1. Male or female aged 18 years and over
2. There is a requirement to prescribe medication to the extent necessary for the physiotherapist to practice physiotherapy,
3. Peripheral musculoskeletal injuries / conditions / symptoms: sprains, strains, suspected simple fractures, subacute and chronic tendinitis, tendinosis, tenosynovitis, bursitis, tenovaginitis (trigger finger, DeQuervain’s) and osteoarthritic arthritic joint disease OR Musculoskeletal pain of spinal origin
4. Ability to provide informed consent and accurately follow the instructions of the researcher
5. Attending emergency department or outpatient clinics for the management of their musculoskeletal condition
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Open wounds
2. Infection
3. Active Inflammatory disease as the primary reason for intervention (i.e. rheumatoid disease and the seronegative arthritides)
4. Neoplastic disease as the primary reason for intervention
5. Cardiovascular disease as the primary reason for intervention
6. Metabolic disease as the primary reason for intervention
7. Central nervous system disorders as the primary reason for intervention
8. Cauda equina injury
9. Acute head injury
10. Loss or altered state of consciousness
11. Pain of non-mechanical origin
12. Polytrauma and high energy injuries including falls from above standing height
13. Respiratory distress
14. Abdominal pain
15. Women who are pregnant and the human foetus

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/08/2015
Actual
11/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2500
Accrual to date
1220
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12588 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 12589 0
Cairns Base Hospital - Cairns
Recruitment hospital [3] 12590 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 12591 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [5] 12592 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 24962 0
4029 - Herston
Recruitment postcode(s) [2] 24963 0
4870 - Cairns
Recruitment postcode(s) [3] 24964 0
4032 - Chermside
Recruitment postcode(s) [4] 24965 0
4108 - Coopers Plains
Recruitment postcode(s) [5] 24966 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 291163 0
Government body
Name [1] 291163 0
Department of Health (Qld)
Country [1] 291163 0
Australia
Primary sponsor type
Hospital
Name
QEII Jubilee Hospital
Address
Cnr Kessels and Troughton Roads
Coopers Plains QLD 4108
Country
Australia
Secondary sponsor category [1] 289840 0
None
Name [1] 289840 0
Address [1] 289840 0
Country [1] 289840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302058 0
Metro South Human Research Ethics Committee (EC00167)
Ethics committee address [1] 302058 0
Ethics committee country [1] 302058 0
Australia
Date submitted for ethics approval [1] 302058 0
11/11/2014
Approval date [1] 302058 0
20/11/2014
Ethics approval number [1] 302058 0
HREC/14/QPAH/385

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56802 0
Mr Mark Cruickshank
Address 56802 0
Physiotherapy Department
L2 Ned Hanlon Bldg
RBWH
Butterfield St HERSTON Queensland 4029
Country 56802 0
Australia
Phone 56802 0
+61 7 3646 7287
Fax 56802 0
Email 56802 0
mark.cruickshank@health.qld.gov.au
Contact person for public queries
Name 56803 0
Mark Cruickshank
Address 56803 0
Physiotherapy Department
L2 Ned Hanlon Bldg
RBWH
Butterfield St HERSTON Queensland 4029
Country 56803 0
Australia
Phone 56803 0
+61 7 3646 7287
Fax 56803 0
Email 56803 0
mark.cruickshank@health.qld.gov.au
Contact person for scientific queries
Name 56804 0
Mark Cruickshank
Address 56804 0
Physiotherapy Department
L2 Ned Hanlon Bldg
RBWH
Butterfield St HERSTON Queensland 4029
Country 56804 0
Australia
Phone 56804 0
+61 7 3646 7287
Fax 56804 0
Email 56804 0
mark.cruickshank@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
558Study protocol    368436-(Uploaded-28-11-2018-16-50-52)-Study-related document.pdf
559Informed consent form    368436-(Uploaded-28-11-2018-16-51-22)-Study-related document.pdf
560Ethical approval    368436-(Uploaded-28-11-2018-16-52-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.