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Trial registered on ANZCTR
Registration number
ACTRN12608000316303
Ethics application status
Approved
Date submitted
3/03/2008
Date registered
1/07/2008
Date last updated
1/07/2008
Type of registration
Prospectively registered
Titles & IDs
Public title
Is triage an effective way of initiating early intervention for patients with a chronic musuloskeletal condition on a hospital waiting list?
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Scientific title
Does physiotherapy triage improve scores on quality of life outcome tools compared with wait-list controls or sham triage for patients with a chronic musculoskeletal condition on a hospital waiting list?
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Musuloskeletal Conditions
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Condition category
Condition code
Musculoskeletal
3452
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
15-20 minute physiotherapy screening/triage appointment within two days of admission to trial. Triage intervention is provision of basic advice for self management, which could be basic pain management advice, basic exercises, encouragement to increase activity levels and/or resource information.
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Intervention code [1]
2630
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Treatment: Other
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Comparator / control treatment
Control group of patients who remain on the waiting list with no intervention. Placebo group is a "sham" triage where patients receive no condition-specific advice but are given a Government brochure on staying active
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Control group
Active
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Outcomes
Primary outcome [1]
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Average score on the Sickness Impact Profile (SIP)
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Assessment method [1]
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Timepoint [1]
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At baseline and at the end of their wait on the waiting list.
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Primary outcome [2]
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Average score on the Orebro Musculoskeletal Pain Questionnaire
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Assessment method [2]
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Timepoint [2]
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At baseline and at the end of their wait on the waiting list.
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Primary outcome [3]
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Average score on the Tampa Scale of Kinesiophobia (TSK)
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Assessment method [3]
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Timepoint [3]
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At baseline and at the end of their wait on the waiting list.
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Secondary outcome [1]
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Visual Analogue Scale (VAS) score
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Assessment method [1]
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Timepoint [1]
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At baseline and at the end of their wait on the waiting list
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Eligibility
Key inclusion criteria
Patients referred to the Calvary Physiotherapy Outpatient Department with a stable chronic pain condition, defined as a pain and/or reduced mobility in one or two related joints or regions for more than 2 months with no recent, severe deterioration.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Pain in more than one unrelated joint/region. Poor grasp of English. Physiotherapy for same condition within 6 months. Under 12 years old. Recent severe deterioration in the condition and/or presence of "red flags".
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients on the waiting list with chronic conditions will be phoned. The researcher has a scripted procedure to inform about the trial, seek verbal consent, and screen for red flags. If the patient agrees to participate, the researcher draws out an envelope from a basket of pre-randomised group allocations, which has a script for the next stage of participating in the trial.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
75
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Melanie Crews
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Address [1]
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17 Louis Loder St
Theodore, ACT, 2905
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Melanie Crews
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Address
17 Louis Loder St
Theodore, ACT, 2905
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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Individual
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Name [1]
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Grant Willson
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Address [1]
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Rm 12C13, Moanna St,
University of Canberra (Physiotherapy, Division of Health, Science and Design), Bruce, ACT, 2617
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research and Ethics Committee
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Ethics committee address [1]
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Calvary Health Care ACT PO Box 254 Jamison Centre ACT 2614
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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14/01/2008
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Approval date [1]
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03/06/2008
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Ethics approval number [1]
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EC00105
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Summary
Brief summary
This study aims to determine if early intervention for chronic pain problems, provided in the form of physiotherapy triage, improves patient outcomes while they wait for their physiotherapy treatment. Triage involves a brief assessment, with advice about pain management, basic exercises and resource information.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Melanie Crews
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Address
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c/o Physiotherapy Department
Calvary Health Care ACT
Cnr Hayden Drive and Belconnen Way
Bruce ACT 2617
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Country
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Australia
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Phone
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+61 2 62016190
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Fax
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+61 2 62016196
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Email
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[email protected]
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Contact person for scientific queries
Name
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Melanie Crews
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Address
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c/o Physiotherapy Department
Calvary Health Care ACT
Cnr Hayden Drive and Belconnen Way
Bruce ACT 2617
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Country
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Australia
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Phone
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+61 2 62016190
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Fax
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+61 2 62016196
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Email
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[email protected]
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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
No additional documents have been identified.
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