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Trial registered on ANZCTR
Registration number
ACTRN12605000032651
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
22/07/2005
Date last updated
15/04/2008
Type of registration
Prospectively registered
Titles & IDs
Public title
Cumberland McKenzie Trial
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Scientific title
The McKenzie Method for the management of acute non-specific low back pain: a randomised controlled trial
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Secondary ID [1]
90
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University of Sydney HREC: 04-2005/3/8135
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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:
Acute non-specific low back pain
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Condition category
Condition code
Musculoskeletal
116
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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
Experimental group: usual general practitioner (GP) care as advocated by the NHMRC guideline for the management of acute musculoskeletal pain. In addition, participants will be referred to physiotherapy to receive up to 7 treatment sessions based on the McKenzie Method.
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Intervention code [1]
37
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Treatment: Other
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Comparator / control treatment
Control group: usual GP care only.
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Control group
Active
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Outcomes
Primary outcome [1]
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1. Usual pain intensity over last 24 hours recorded each morning in a pain diary over the first week. The unit of analysis is the mean of the 7 measures
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Assessment method [1]
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Timepoint [1]
144
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Recorded each morning in a pain diary over the first week
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Primary outcome [2]
145
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2. Usual pain intensity over last 24 hours
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Assessment method [2]
145
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Timepoint [2]
145
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Recorded at 1 and 3 weeks
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Primary outcome [3]
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3. Global perceived effect
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Assessment method [3]
146
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Timepoint [3]
146
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Recorded at 3 weeks
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Secondary outcome [1]
318
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1. Global perceived effect
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Assessment method [1]
318
0
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Timepoint [1]
318
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Recorded at 1 week
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Secondary outcome [2]
319
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2. Patient-generated measure of disability
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Assessment method [2]
319
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Timepoint [2]
319
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Recorded at 1 and 3 weeks
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Secondary outcome [3]
320
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3. Condition-specific measure of disability
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Assessment method [3]
320
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Timepoint [3]
320
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Recorded at 1 and 3 weeks
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Secondary outcome [4]
321
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4. Number of patients reporting persistent back pain
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Assessment method [4]
321
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Timepoint [4]
321
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At 3 months
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Eligibility
Key inclusion criteria
Pain extending in an area between the 12th rib and the buttock crease with or without leg pain; pain duration >24 hours < 6 weeks; eligibility to be referred to private physiotherapy practice.
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Clear neurological signs; known or suspected serious spinal pathology; spinal surgery within the preceding 6 months; pregnancy; severe cardiovascular or metabolic disease; inability to read English.
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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)
Sequentially numbered sealed envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified random allocation sequence will be generated by a computer program. Randomisation will be in blocks and will be stratified by workcover compensation status (yes/no)
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Masking / blinding
Open (masking not 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
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2005
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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
148
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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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Recruitment postcode(s) [1]
197
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NSW
2040/2042/2070/2075/2077/2081/2082/2100/2114/2116/2118/2121/2137/2144/2145/2146/2148/2151/2153/2154/2155/2160/2165/2221/2230/2233/2756
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Research and Development Grant (R&D)University of Sydney
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Address [1]
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School of Physiotherapy East St Lidcombe NSW 2141
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
School of Physiotherapy East St Lidcombe NSW 2141
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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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nil
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Address [1]
116
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Country [1]
116
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
906
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
906
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Approval date [1]
906
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Ethics approval number [1]
906
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04-2005/3/8135
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Summary
Brief summary
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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
35780
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Country
35780
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Phone
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Fax
35780
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Email
35780
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Contact person for public queries
Name
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Mrs Luciana Machado
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Address
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Back Pain Research Group, Musculoskeletal Division, The George Institute for International Health, PO Box M201, Missenden Rd Camperdown NSW 2050 Australia
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Country
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Australia
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Phone
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+61 2 93519671
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Fax
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+61 2 93519681
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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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Prof Chris Maher
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Address
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Back Pain Research Group, Musculoskeletal Division, The George Institute for International Health, PO Box M201, Missenden Rd Camperdown NSW 2050 Australia
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Country
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Australia
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Phone
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+61 2 93519192
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Fax
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+61 2 93519601
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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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