Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000335099
Ethics application status
Approved
Date submitted
26/04/2010
Date registered
28/04/2010
Date last updated
2/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brain Effects of Acupuncture - 1
Needle acupuncture vs Laser acupuncture
Scientific title
A comparison of Needle acupuncture versus Laser acupuncture at acupoint LR8 in Healthy Subjects - using functional magnetic resonance imaging (fMRI).
Secondary ID [1] 251656 0
None
Universal Trial Number (UTN)
Trial acronym
NVL study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain effects of two different modalities of acupuncture intervention : Needle vs Laser 257244 0
Condition category
Condition code
Alternative and Complementary Medicine 257384 257384 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Functional MRI (fMRI) of Needle acupuncture at LR8 at medial knee (located between the tendons of semitendinosis and semimembranosis muscles) followed by, in same session
2.Functional magentic resonance imaging (fMRI) continues while Laser acupuncture (low level -804nm, Energy delivered Total 2.56J) at the opposite side LR8 acupoint is delivered.
3.N=16, eight healthy subjects per arm, order of Note:Laser or Needle first is randomised. 4.Single session. Duration approximately 20minutes in the scanner.
5.Block design. 16 second blocks with rest and active intervention ( needle or laser) alternating blocks. Total 9 Rests and 8 actives.
6. Active laser being 20mW low level laser activation in the 16 second blocks.
7. Needle being 0.22 x 25mm silver disposable Helio acupuncture needles stimulated at 1Hz cycles to achieve the sensation of "de qi" like a dull ache.
Intervention code [1] 256363 0
Treatment: Other
Comparator / control treatment
Not applicable. This is a basic science experiment to test what needle acupuncture does compared to laser acupuncture on LR8 acupoint in brain activation patterns, when both interventions are performed on the same subject in the same session.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258295 0
Brain activation patterns of needle acupuncture
using Statistical Parametric Mapping software (SPM) to identify the brain regions positively or negatively activated compared to rest and compared to laser stimulation.
Timepoint [1] 258295 0
At the conclusion of the single session
Primary outcome [2] 258296 0
Brain activation patterns of laser acupuncture
using Statistical Parametric Mapping software (SPM) to identify the brain regions positively or negatively activated compared to rest and compared to needle stimulation.
Timepoint [2] 258296 0
At the conclusion of the single session.
Secondary outcome [1] 263999 0
Nil
Timepoint [1] 263999 0
Nil

Eligibility
Key inclusion criteria
Healthy subject
Able to participate in MRI experiment
Able to give informed consent
Right handed
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Brain injury
Past surgery involving the lower limbs
Any ongoing illness or chronic illness
Any factors contraindicated in MRI investigations ( pace maker, metal foreign bodies , anxiety about the procedure as in claustrophobia)

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)
1. recruitment was by group internal email at the University, Black Dog Institute and Prince of Wales Hospital as well as by advertisement flyers at the participating medical acupuncturist's clinical rooms.
2. treatment allocation was by the medical acupuncturist, allocation to which intervention ( laser or needle) on which side ( left or right) by paper lots so that in the end, half ( n=8) were needle acupuncture first and half were laser acupuncture first ( n=8) in the block design .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1. Sidedness ( left or right)
2. Intervention ( needle or laser)
were decided on the day for each subject by toss of a coin.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
1.Block design with rest -active -rest -active blocks, in total 9 Rests and 8 Active

2.Intervention ( Needle or laser):

The silver 0.22 gauge x 25 mm silver needles were manually stimulated for de qi sensation at 1 HZ cycles for 16 seconds per block

Low level laser was with 804nm infra red laser 20mW for 16 second per block.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/04/2009
Actual
28/04/2009
Date of last participant enrolment
Anticipated
Actual
9/07/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2859 0
2031
Recruitment postcode(s) [2] 2843 0
2069

Funding & Sponsors
Funding source category [1] 256868 0
Charities/Societies/Foundations
Name [1] 256868 0
Thyne-Reid Foundation
Country [1] 256868 0
Australia
Funding source category [2] 256869 0
Other
Name [2] 256869 0
Louise Dobson and family
Country [2] 256869 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Prof Perminder Sachdev
Neuropsychiatric Institute
NPI
Euroa Centre
Prince of Wales Hospital PoWH
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 256143 0
University
Name [1] 256143 0
University of New South Wales UNSW
Address [1] 256143 0
Dr Im Quah-Smith
c/- School of Psychiatry
Hospital Rd
Randwick
NSW 2031
Country [1] 256143 0
Australia
Other collaborator category [1] 1215 0
Individual
Name [1] 1215 0
Dr Mark Williams
Address [1] 1215 0
Macquarie Centre for Cognitive Sciences MACCS
Macquarie University
North Ryde
NSW 2113
Country [1] 1215 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258879 0
Human Research Ethics Committee, South East Health, South East Sydney Area Health Service
Ethics committee address [1] 258879 0
South East Health
Human Research Ethics Committee
90 Russell Avenue
Dolls Point
NSW 2219
Ethics committee country [1] 258879 0
Australia
Date submitted for ethics approval [1] 258879 0
Approval date [1] 258879 0
10/05/2005
Ethics approval number [1] 258879 0
1/05/0073

Summary
Brief summary
An experimental study to compare the brain effects of needle versus laser acupuncture on one acupoint (LR8) in healthy subjects using functional MRI.
Trial website
laserneedlestudy@gmail.com
Trial related presentations / publications
1. Laser acupuncture in mild to moderate depression- a randomised controlled trial. Quah-Smith JI, Tang WM, Russell, J. Acupuncture in Medicine 2005;23(3):103-111

2. Is the Traditonal Chinese Medicine ( TCM) concept of excess and deficiency valid? Preliminary fMRI evidence. Presentation and poster award ICCMR 30 March 2008 Sydney, Australia

3. Neuroimaging evidence for acupuncture. Translating the Classics- from TCM to EBM, Kuala Lumpur 3-4 April 2010.

4.Quah-Smith I, Williams M A, Lundeberg T, Suo C, Sachdev P S. The differential effects of laser and needle acupuncture at LR8 using functional MRI. Acupunct Med 2013;31:282-289 doi:10.1136/acupmed-2012-010297.).
Public notes

Contacts
Principal investigator
Name 31097 0
Dr Im Quah-Smith
Address 31097 0
Roseville Wellness Group
3/32 Barcoo St
Roseville
NSW 2069
Country 31097 0
Australia
Phone 31097 0
612 94174772
Fax 31097 0
Email 31097 0
jiqs@tpg.com.au
Contact person for public queries
Name 14344 0
Dr Dr Im Quah-Smith
Address 14344 0
Roseville Wellness Group
3 / 32 Barcoo St
Roseville
NSW 2069
Country 14344 0
Australia
Phone 14344 0
612 94174772
Fax 14344 0
612 94755035
Email 14344 0
jiqs@tpg.com.au
Contact person for scientific queries
Name 5272 0
Prof Prof Perminder Sachdev
Address 5272 0
CHeBA
Centre for Healthy Brain Aging
UNSW Medicine
Randwick
NSW 2031
Country 5272 0
Australia
Phone 5272 0
612 9382 3763
Fax 5272 0
612 9382 3774
Email 5272 0
psachdev@unsw.edu.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

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