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Trial registered on ANZCTR


Trial ID
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
Scientific title
The McKenzie Method for the management of acute non-specific low back pain: a randomised controlled trial
Secondary ID [1] 90 0
University of Sydney HREC: 04-2005/3/8135
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute non-specific low back pain 95 0
Condition category
Condition code
Musculoskeletal 116 116 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 37 0
Treatment: Other
Comparator / control treatment
Control group: usual GP care only.
Control group
Active

Outcomes
Primary outcome [1] 144 0
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
Timepoint [1] 144 0
Recorded each morning in a pain diary over the first week
Primary outcome [2] 145 0
2. Usual pain intensity over last 24 hours
Timepoint [2] 145 0
Recorded at 1 and 3 weeks
Primary outcome [3] 146 0
3. Global perceived effect
Timepoint [3] 146 0
Recorded at 3 weeks
Secondary outcome [1] 318 0
1. Global perceived effect
Timepoint [1] 318 0
Recorded at 1 week
Secondary outcome [2] 319 0
2. Patient-generated measure of disability
Timepoint [2] 319 0
Recorded at 1 and 3 weeks
Secondary outcome [3] 320 0
3. Condition-specific measure of disability
Timepoint [3] 320 0
Recorded at 1 and 3 weeks
Secondary outcome [4] 321 0
4. Number of patients reporting persistent back pain
Timepoint [4] 321 0
At 3 months

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.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
Sequentially numbered sealed envelopes
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 197 0
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

Funding & Sponsors
Funding source category [1] 161 0
University
Name [1] 161 0
Research and Development Grant (R&D)University of Sydney
Address [1] 161 0
School of Physiotherapy East St Lidcombe NSW 2141
Country [1] 161 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
School of Physiotherapy East St Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 116 0
None
Name [1] 116 0
nil
Address [1] 116 0
Country [1] 116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 906 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 906 0
Ethics committee country [1] 906 0
Australia
Date submitted for ethics approval [1] 906 0
Approval date [1] 906 0
Ethics approval number [1] 906 0
04-2005/3/8135

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

Contacts
Principal investigator
Name 35780 0
Address 35780 0
Country 35780 0
Phone 35780 0
Fax 35780 0
Email 35780 0
Contact person for public queries
Name 9226 0
Mrs Luciana Machado
Address 9226 0
Back Pain Research Group, Musculoskeletal Division, The George Institute for International Health, PO Box M201, Missenden Rd Camperdown NSW 2050 Australia
Country 9226 0
Australia
Phone 9226 0
+61 2 93519671
Fax 9226 0
+61 2 93519681
Email 9226 0
machadolac@hotmail.com
Contact person for scientific queries
Name 154 0
Prof Chris Maher
Address 154 0
Back Pain Research Group, Musculoskeletal Division, The George Institute for International Health, PO Box M201, Missenden Rd Camperdown NSW 2050 Australia
Country 154 0
Australia
Phone 154 0
+61 2 93519192
Fax 154 0
+61 2 93519601
Email 154 0
C.Maher@fhs.usyd.edu.au