Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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?
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?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Musuloskeletal Conditions 3290 0
Condition category
Condition code
Musculoskeletal 3452 3452 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 2630 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 3919 0
Average score on the Sickness Impact Profile (SIP)
Timepoint [1] 3919 0
At baseline and at the end of their wait on the waiting list.
Primary outcome [2] 3920 0
Average score on the Orebro Musculoskeletal Pain Questionnaire
Timepoint [2] 3920 0
At baseline and at the end of their wait on the waiting list.
Primary outcome [3] 3921 0
Average score on the Tampa Scale of Kinesiophobia (TSK)
Timepoint [3] 3921 0
At baseline and at the end of their wait on the waiting list.
Secondary outcome [1] 6596 0
Visual Analogue Scale (VAS) score
Timepoint [1] 6596 0
At baseline and at the end of their wait on the waiting list

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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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".

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3152 0
Self funded/Unfunded
Name [1] 3152 0
Melanie Crews
Country [1] 3152 0
Australia
Primary sponsor type
Individual
Name
Melanie Crews
Address
17 Louis Loder St
Theodore, ACT, 2905
Country
Australia
Secondary sponsor category [1] 2828 0
None
Name [1] 2828 0
Address [1] 2828 0
Country [1] 2828 0
Other collaborator category [1] 221 0
Individual
Name [1] 221 0
Grant Willson
Address [1] 221 0
Rm 12C13, Moanna St,
University of Canberra (Physiotherapy, Division of Health, Science and Design), Bruce, ACT, 2617
Country [1] 221 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5536 0
Human Research and Ethics Committee
Ethics committee address [1] 5536 0
Calvary Health Care ACT
PO Box 254
Jamison Centre
ACT 2614
Ethics committee country [1] 5536 0
Australia
Date submitted for ethics approval [1] 5536 0
14/01/2008
Approval date [1] 5536 0
03/06/2008
Ethics approval number [1] 5536 0
EC00105

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28421 0
Address 28421 0
Country 28421 0
Phone 28421 0
Fax 28421 0
Email 28421 0
Contact person for public queries
Name 11578 0
Melanie Crews
Address 11578 0
c/o Physiotherapy Department
Calvary Health Care ACT
Cnr Hayden Drive and Belconnen Way
Bruce ACT 2617
Country 11578 0
Australia
Phone 11578 0
+61 2 62016190
Fax 11578 0
+61 2 62016196
Email 11578 0
[email protected]
Contact person for scientific queries
Name 2506 0
Melanie Crews
Address 2506 0
c/o Physiotherapy Department
Calvary Health Care ACT
Cnr Hayden Drive and Belconnen Way
Bruce ACT 2617
Country 2506 0
Australia
Phone 2506 0
+61 2 62016190
Fax 2506 0
+61 2 62016196
Email 2506 0
[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
No additional documents have been identified.