Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000367640
Ethics application status
Approved
Date submitted
19/08/2005
Date registered
13/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
RCT of laser acupuncture in acute low back pain.
Scientific title
Double blind randomised controlled trial of laser acupuncture in acute and subacute low back pain as measured by Oswestry disability index.
Universal Trial Number (UTN)
Trial acronym
LoBACu
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute and subacute low back pain 462 0
Condition category
Condition code
Alternative and Complementary Medicine 539 539 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 weeks laser acupuncture
Intervention code [1] 214 0
Prevention
Comparator / control treatment
8 weeks sham laser acupuncture
Control group
Placebo

Outcomes
Primary outcome [1] 630 0
Oswestry Disability Index
Timepoint [1] 630 0
Measured weekly for 8 weeks, then at follow up (3, 6, 9, 12 months)
Secondary outcome [1] 1300 0
K10
Timepoint [1] 1300 0
Measured at commencement and follow up (3,6,9,12 months).
Secondary outcome [2] 1301 0
VAS
Timepoint [2] 1301 0
Measured weekly for 8 weeks, then at follow up (3,6,9,12 months).
Secondary outcome [3] 1302 0
Medication
Timepoint [3] 1302 0
Measured weekly for 8 weeks, then at follow up (3,6,9,12 months).
Secondary outcome [4] 1303 0
Health Utilization
Timepoint [4] 1303 0
Measured weekly for 8 weeks, then at follow up (3,6,9,12 months).

Eligibility
Key inclusion criteria
2-8 wks of back pain.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic LBP, significant medical conditions.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
yes - independent allocation - wired and sealed into laser machine with no access and no bypass switch
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers generated in Excel, stratification by GP and block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
special laser probe for double blinding
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 597 0
University
Name [1] 597 0
University Melb.Dept. Gen Practice
Country [1] 597 0
Australia
Primary sponsor type
University
Name
Melbourne University
Address
Country
Australia
Secondary sponsor category [1] 486 0
None
Name [1] 486 0
nil
Address [1] 486 0
Country [1] 486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1694 0
Melbourne University
Ethics committee address [1] 1694 0
Ethics committee country [1] 1694 0
Australia
Date submitted for ethics approval [1] 1694 0
Approval date [1] 1694 0
Ethics approval number [1] 1694 0
Ethics committee name [2] 1695 0
Epworth Hospital
Ethics committee address [2] 1695 0
Ethics committee country [2] 1695 0
Australia
Date submitted for ethics approval [2] 1695 0
Approval date [2] 1695 0
Ethics approval number [2] 1695 0

Summary
Brief summary
General practice recruitment aswell as A&E
12 month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35310 0
Address 35310 0
Country 35310 0
Phone 35310 0
Fax 35310 0
Email 35310 0
Contact person for public queries
Name 9403 0
Dr Marie Pirotta
Address 9403 0
Department of General Practice
University of Melbourne
200 Berkley Street
Carlton VIC 3053
Country 9403 0
Australia
Phone 9403 0
+61 3 83449723
Fax 9403 0
Email 9403 0
[email protected]
Contact person for scientific queries
Name 331 0
Dr Ian Relf
Address 331 0
Department of General Practice
University of Melbourne
200 Berkley Street
Carlton VIC 3053
Country 331 0
Australia
Phone 331 0
+61 3 83443369
Fax 331 0
Email 331 0
[email protected] .au

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.