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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional Magnetic Resonance Imaging (fMRI) investigation of Laser Acupuncture on Acupoints useful in Mild to Moderate Unipolar Depression.
Scientific title
Functional magnetic resonance imaging (fMRI) of laser acupuncture on unipolar depressed subjects using highly significant acupoints for mild to moderate depression by randomised controlled trial.
Secondary ID [1] 251664 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unipolar depression 257264 0
Condition category
Condition code
Alternative and Complementary Medicine 257403 257403 0 0
Other alternative and complementary medicine
Mental Health 257404 257404 0 0

Study type
Description of intervention(s) / exposure
1. Laser acupuncture to 4 acupoints found by double blind randomised controlled trial to be highly significant in the treatment of depression, and to a fifth acupoint KI3 added for anxiety management according to Traditional Chinese Medicine diagnosis or TCM diagnosis).
2. The acupoints are lasered in random order and the process repeated once so each acupoint is lasered twice in a single session.
3. The fibreoptic laser is a 804nm continuous beam laser, 25mW delivered over 20 seconds per block (0.5Joules).Total 35 minutes in the scanner, actual laser time being
4. Nine Rest blocks alternate with eight Active laser blocks. Blocks are 20 seconds duration.
5. Acupoints used were LR14, CV14, HT7 and LR8 from the randomised controlled trial amd KI3.
LR14 on right at 6th intercostal space, midclavicular line
CV14 in epigastrium about 10cm from the xiphisternum
HT7 is at left medial wrist
LR8 is at medial knee on Left between semimembranosis and semitendinosus muscles.
KI3 is at right medial knee.
Intervention code [1] 256382 0
Treatment: Other
Comparator / control treatment
Control is the sham laser / rest components of the block design.
Control group

Primary outcome [1] 258328 0
Brain positive and negative activation patterns from laser acupuncture to acupoints CV14, LR14, HT7, LR8 and KI3 in unipolar depressed subjects
Timepoint [1] 258328 0
At the conclusion of the single session using MatLab and Statistical Parametric Mapping ( SPM)
to analyse the significant positive and negative activations from laser to the acupoints LR14, CV14,
Secondary outcome [1] 264037 0
Timepoint [1] 264037 0

Key inclusion criteria
1.Unipolar depression according to Diagnostic and Statistical Mental Health Manual Version IV ( DSM-IV)
2.Montgomery Anxiety and Depression Rating Scale (MADRS) score over 12
3.Hamilton Depression Scale (HAM-D) score over 12
4. Able to give informed consent
5. Depression of less than 2 years duration
6. Right handed
Minimum age
18 Years
Maximum age
50 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1.Non unipolar depression
2. Depression of over 2 years duration
3. Chronic dysthmia
4. Suicidal tendencies
5. Pregnancy
6. Chronic uncontrolled illness
7. Brain Injury
8. Conditions contraindicated for magnetic
resonance imaging ( pace maker, metallic
foreign bodies)

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment was by online advertisement to personnel in the Prince of Wales and Sydney Childrens Hospital as well as the University of New South Wales. Flyers were made and distributed to general practices in the district. Those who fulfilled the MADRS score were then invited for a face to face interview to score on the HAM-D. Positive scores to both these were necessary for recruitment. All subjects received real laser in block design as described and the order of acupoints being lasered was randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Acupoint randomisation was by draw lots. The 5 acupoints were written down on paper lots and placed in a box. Order of drawing was order of acupoint stimulation. The repeat acupoint stimulation was also similarly randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2865 0
Recruitment postcode(s) [2] 2879 0

Funding & Sponsors
Funding source category [1] 256885 0
Name [1] 256885 0
Prince of Wales Hospital
Address [1] 256885 0
Prof Perminder Sachdev
Neuropsychiatric Institute NPI
Prince of Wales Hospital
Euroa Centre
Barker Street
Randwick NSW 2031
Country [1] 256885 0
Primary sponsor type
Prince of Wales Hospital
Dr Im Quah-Smith
Neuropsychiatric Institute NPI
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Secondary sponsor category [1] 256158 0
Name [1] 256158 0
Address [1] 256158 0
Country [1] 256158 0
Other collaborator category [1] 1241 0
Name [1] 1241 0
Dr Mark Williams
Address [1] 1241 0
Macquarie Centre for Cognitive Sciences MACCS
Macquarie University
North Ryde
NSW 2113
Country [1] 1241 0

Ethics approval
Ethics application status
Ethics committee name [1] 258898 0
Human Research Ethics Committee South East Health , South East Sydney Area Health Service (SEAHS)
Ethics committee address [1] 258898 0
South East Health
90 Russell Street
Dolls Point
NSW 2119
Ethics committee country [1] 258898 0
Date submitted for ethics approval [1] 258898 0
Approval date [1] 258898 0
Ethics approval number [1] 258898 0

Brief summary
Investigation of the brain activation patterns of 4 acupoints ( LR14, CV14 HT7 and LR8) found to be highly significant in the treatment of unipolar depression in a double blind randomised controlled trial and an additional acupoint KI3 considered useful in associated anxiety and fatigue in depression.
Trial website
Trial related presentations / publications
Quah-Smith I, Wen W, Chen X, et al. The brain effects of laser acupuncture in depressed individuals: an fMRI investigation. Med Acupunct 2012;24:161–71

Quah-Smith I, Suo C, Williams M A, Sachdev P S. The Antidepressant Effect of Laser Acupuncture: A Comparison of the Resting Brain’s Default Mode Network in Healthy and Depressed Subjects using Functional Magnetic Resonance Imaging. Med Acup: 25, Nr 0, 2013. DOI: 10.1089/acu.2012.0901

Quah-Smith I, Wen W, Chen X, et al. The brain effects of laser acupuncture in depressed individuals: an fMRI investigation. Med Acupunct 2012;24:161–71
Public notes

Principal investigator
Name 31106 0
Dr Im Quah-Smith
Address 31106 0
Roseville Wellness Group
3/32 Barcoo Street
NSW 2069
Country 31106 0
Phone 31106 0
612 94174772
Fax 31106 0
Email 31106 0
Contact person for public queries
Name 14353 0
Dr DR Im Quah-Smith
Address 14353 0
Roseville Wellness Group
3/32 Barcoo Street
NSW 2069
Country 14353 0
Phone 14353 0
612 94174772
Fax 14353 0
612 94755035
Email 14353 0
Contact person for scientific queries
Name 5281 0
Prof Prof Perminder Sachdev
Address 5281 0
Neuropsychiatric Institute NPI
Prince of Wales Hospital PoWH
Barker Street
Randwick NSW 2031
Country 5281 0
Phone 5281 0
612 9382 3763
Fax 5281 0
612 9382 3774
Email 5281 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary