Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000105448
Ethics application status
Approved
Date submitted
18/12/2006
Date registered
2/02/2007
Date last updated
16/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to determine if laser acupuncture is of useful in the treatment of chronic low back pain
Scientific title
Clinical trial to examine the effectiveness of laser acupuncture treatment in reducing pain and disability in chronic non specific low back pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 1599 0
Condition category
Condition code
Alternative and Complementary Medicine 1702 1702 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(i)Study intervention is laser acupuncture using an infrared 10mv laser. (iii) The appointment for each treatment session lasts 15 minutes.
The laser is directed to points in the low back area as well as on the limbs and elsewhere selected according to principles of acupuncture treatment. The points selected are individualized for each participant.
(iv)Participants usually receive treatment once a week for up to maximum of 10 sessions.
Intervention code [1] 1511 0
Treatment: Devices
Comparator / control treatment
(ii)Control intervention uses a sham laser .The appointment for each treatment session lasts 15 minutes. Participants usually receive treatment once a week for up to maximum of 10 sessions.
Control group
Placebo

Outcomes
Primary outcome [1] 2362 0
1. pain measured by visual analogue scale (VAS)
Timepoint [1] 2362 0
At the last treatment
Primary outcome [2] 2363 0
2. disability measured by Oswestry Disability Questionnaire (ODQ)
Timepoint [2] 2363 0
At the last treatment
Secondary outcome [1] 4114 0
1. Pain measured by VAS
Timepoint [1] 4114 0
At 6 weeks follow up
Secondary outcome [2] 4115 0
2. Depression,Anxiety Stress Scale 21 (DASS21)
Timepoint [2] 4115 0
At end of treatnent and at 6 weeks follow up
Secondary outcome [3] 4116 0
3. ODQ
Timepoint [3] 4116 0
At 6 weeks follow up
Secondary outcome [4] 4117 0
4. Global Assessment (GA)
Timepoint [4] 4117 0
At end treatment, at 6 weeks follow up and at 6 months follow up.
Secondary outcome [5] 4118 0
5. Personal Wellbeing Index (PWI-A)
Timepoint [5] 4118 0
At 6 weeks follow up

Eligibility
Key inclusion criteria
Chronic low back pain
Minimum age
19 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i)specific causes for back pain such as radiculopathy caused by disc prolapse , spinal stenosis , osteoporotic vertebral fracture , neoplasia or infection, (ii) pregnancy, (iii)current involvement with Work Cover or insurance, (iv)treatment with narcotic analgesics , (v)low back surgery in previous 2 years. (vi) Acupuncture or facet block injections to low back in previous 3 months.

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)
Allocation was concealed by 4. allocation involved contacting the holder of the allocation schedule who was "Off -Site" (Melbourne University)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All parties are blinded within this study ie Subjects, therapist,assessor and data analyst
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1847 0
University
Name [1] 1847 0
Monash University
Country [1] 1847 0
Australia
Funding source category [2] 1848 0
Charities/Societies/Foundations
Name [2] 1848 0
Australian Medical Acupuncture College
Country [2] 1848 0
Australia
Primary sponsor type
Individual
Name
Dr Gregory Glazov
Address
Country
Secondary sponsor category [1] 1663 0
None
Name [1] 1663 0
Nil
Address [1] 1663 0
Country [1] 1663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3447 0
Mindarie Keys Medical Centre-Monash University SCERH
Ethics committee address [1] 3447 0
Mindarie Keys Medical Centre, Rothesay Heights, Mindarie WA 6030
Ethics committee country [1] 3447 0
Australia
Date submitted for ethics approval [1] 3447 0
Approval date [1] 3447 0
Ethics approval number [1] 3447 0
2005/498

Summary
Brief summary
To determine if acupuncture using a low power infrared laser has a benefit greater than that achieved by non- specific factors(placebo) in the treatment of chronic low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27445 0
Address 27445 0
Country 27445 0
Phone 27445 0
Fax 27445 0
Email 27445 0
Contact person for public queries
Name 10700 0
Gregory Glazov
Address 10700 0
PO Box 81 Kingsway WA 6065
Country 10700 0
Australia
Phone 10700 0
+61 8 94077311
Fax 10700 0
Email 10700 0
glazovfam@iinet.net.au
Contact person for scientific queries
Name 1628 0
Dr Gregory Glazov
Address 1628 0
PO Box 81 Kingsway WA 6065
Country 1628 0
Australia
Phone 1628 0
+61 8 94077311
Fax 1628 0
Email 1628 0
glazovfam@iinet.net.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.