Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ANZCTR |
Last refreshed on:
|
13 January 2020 |
Main ID: |
ACTRN12615000525583 |
Date of registration:
|
26/05/2015 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
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? |
Date of first enrolment:
|
11/05/2017 |
Target sample size:
|
2500 |
Recruitment status: |
Recruiting |
URL:
|
https://anzctr.org.au/ACTRN12615000525583.aspx |
Study type:
|
Interventional |
Study design:
|
Purpose: Treatment; Allocation: Non-randomised trial;
|
Phase:
|
|
|
Countries of recruitment
|
Australia
| | | | | | | |
Contacts
|
Name:
|
Mr Mark Cruickshank
|
Address:
|
Physiotherapy Department
L2 Ned Hanlon Bldg
RBWH
Butterfield St HERSTON Queensland 4029
Australia |
Telephone:
|
+61 7 3646 7287 |
Email:
|
mark.cruickshank@health.qld.gov.au |
Affiliation:
|
|
|
Name:
|
Mr Mark Cruickshank
|
Address:
|
Physiotherapy Department
L2 Ned Hanlon Bldg
RBWH
Butterfield St HERSTON Queensland 4029
Australia |
Telephone:
|
+61 7 3646 7287 |
Email:
|
mark.cruickshank@health.qld.gov.au |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
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
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
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
|
Health Condition(s) or Problem(s) studied
|
Injuries and Accidents - Other injuries and accidents
|
Musculoskeletal pain of spinal origin;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
; Musculoskeletal pain of spinal origin 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
|
Physical Medicine / Rehabilitation - Physiotherapy
|
Musculoskeletal - Other muscular and skeletal disorders
|
Intervention(s)
|
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)
|
Primary Outcome(s)
|
Number of adverse events, measured as number of clinical incidents reported and related to the physiotherapist intervention[Within 1 month post intervention]
|
Secondary Outcome(s)
|
Staff satisfaction as measured on a 5 point Likert Scale[Within 6 months of trial commencement]
|
Patient satisfaction as measured on a 5 point Likert Scale[Within one week of intervention]
|
Source(s) of Monetary Support
|
Department of Health (Qld)
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Metro South Human Research Ethics Committee (EC00167)
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|