Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000043033
Ethics application status
Approved
Date submitted
7/10/2009
Date registered
15/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laser acupuncture in chronic low back pain trial.
Scientific title
Multicentre double blind trial to examine the efficacy of a 830 nm class 3b laser for the laser acupuncture treatment of chronic non-specific low back pain.
Secondary ID [1] 1285 0
'none'
Universal Trial Number (UTN)
U1111-1113-3037
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-specific low back pain 256528 0
Condition category
Condition code
Alternative and Complementary Medicine 256701 256701 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laser level infra red laser stimulation of acupuncture points invoves applying a laser emitting probe to selected points on the body surface. These are tender points at the site of pain and other distal points selected according to acupunture theory principles. Points are inividualised for each patient and betweeen treatment sessions . They are stimulatied with laser for a specified duration of time according to directions at randomization.
The duration of each treament session including general patient contact is 15 minutes. Frequency of sessions is once a week for 8 weeks.
Intervention code [1] 255808 0
Other interventions
Comparator / control treatment
Sham laser acupuncture involves the application of the same probe to selected points on the body surface, but where no laser radiation is emitted. These are tender points at the site of pain and other distal points selected according to acupunture theory principles. Points are inividualised for each patient and betweeen treatment sessions . They are stimulatied with laser for a specified duration of time according to directions at randomization.
The duration of each treament session including general patient contact is 15 minutes. Frequency of sessions is once a week for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 238168 0
Pain (Numerical Rating Scale for Pain)
Timepoint [1] 238168 0
6 week after completion of course of treatment
Primary outcome [2] 238169 0
Disability ( Oswestry Disability Index)
Timepoint [2] 238169 0
6 week after completion of course of treatment
Secondary outcome [1] 242450 0
Pain (Numerical Rating Scale for Pain)
Timepoint [1] 242450 0
(post treatment, 6 months, 12 months)
Secondary outcome [2] 242451 0
Disability (Oswestry Disability Index )
Timepoint [2] 242451 0
(post treatment, 6 months, 12 months)
Secondary outcome [3] 242452 0
Global rating scale (effectiveness of treatment using 7 point Likert scale)
Timepoint [3] 242452 0
post treatment/ 6 weeks /6 months /12 months

Eligibility
Key inclusion criteria
Chronic non-specific low back pain (duration >3 months )
Minimum age
19 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Baseline pain < 3 (Numerical Pain Rating Scale )
Secondary causes of back pain present.
Fibromyalgia.
Pregnancy/ within 3 months postpartum.
Taking regular opioid analgesics.
Disability Support Pension for back pain.
Workers Compensation or other insurance related cause for back pain.
Previous lumbar surgery .
Previous specialist injections for back pain
Acupuncture /dry needling for back pain in previous 6 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)
sealed opaque envelopes
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237163 0
Government body
Name [1] 237163 0
Primary Health Care Research, Evaluation and Development (PHCRED) Grant
Country [1] 237163 0
Australia
Primary sponsor type
Individual
Name
Dr Gregory Glazov
Address
PO Box 81 Kingsway WA 6065
Country
Australia
Secondary sponsor category [1] 4652 0
None
Name [1] 4652 0
Address [1] 4652 0
Country [1] 4652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239255 0
Human Research Ethics Committee Research Services
Ethics committee address [1] 239255 0
University of Western Australia
35 Stirling Hway, Crawley, WA 6009
Ethics committee country [1] 239255 0
Australia
Date submitted for ethics approval [1] 239255 0
01/06/2008
Approval date [1] 239255 0
30/06/2008
Ethics approval number [1] 239255 0
RA/4/12057

Summary
Brief summary
To determine if low level laser stimulation of acupunctrure points in a course of 8 weekly trearments is effective in relieving pain and disability in patients with chronic low back pain .
Trial website
not available
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29751 0
Address 29751 0
Country 29751 0
Phone 29751 0
Fax 29751 0
Email 29751 0
Contact person for public queries
Name 12998 0
Dr Gregory Glazov
Address 12998 0
PO Box 81 Kingsway WA 6065
Country 12998 0
Australia
Phone 12998 0
+61 894032399
Fax 12998 0
Email 12998 0
[email protected]
Contact person for scientific queries
Name 3926 0
Dr Gregory Glazov
Address 3926 0
PO Box 81 Kingsway WA 6065
Country 3926 0
Australia
Phone 3926 0
+61 894032399
Fax 3926 0
Email 3926 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.