Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000344099
Ethics application status
Approved
Date submitted
27/04/2010
Date registered
29/04/2010
Date last updated
29/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brain Effects of Acupuncture 2 : Laser acupuncture vs Laser EMLA
Scientific title
Does blockade of afferent nerve fibres with EMLA local anaesthetic patch block the laser acupuncture brain effect in healthy subjects : a functional Magnetic Resonance Imaging (fMRI) study
Secondary ID [1] 251662 0
Nil
Universal Trial Number (UTN)
Trial acronym
LEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Investigation of the afferent nerve fibres involved in laser acupuncture 257245 0
Condition category
Condition code
Alternative and Complementary Medicine 257385 257385 0 0
Other alternative and complementary medicine
Neurological 257400 257400 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Each subject was asked to apply the EMLA patch (local anaesthetic patch: 5% eutectic emulsion of lidocaine (25mg/g of emulsion) and prilocaine (25 mg/g) with amount of EMLA per patch 1g) at least one hour, max 2 hours before attending the MRI (3 Tesla Philips) scanning room to either the left or right wrist at HT7 acupoint.
2.Removal of EMLA patch
3.Temperature recorded of both HT7 areas: EMLA patched site and control site opposite site.
4. Testing and recording of residual sensation to touch at EMLA site and control site with :
Brushing ( a soft bristle paintbrush gently stroked on the skin where EMLA patch had been applied)
Prick ( using a toothpick on the same area)
Cold ( using a metal rod which has not been exposed to warmth, so it has a cold feel)
Heat ( using metal rod warmed to 50 celsius in baby bottle warmer)
5 Laser acupuncture intervention to both HT7 acupoints in each subject at the same session. EMLA HT7 and Control HT7 in each subject are lasered in random order (toss of gold coin) Fibreoptic Continuous Beam Laser wavelength 804nm, 20mW in eight 16 second Active laser blocks, alternating with Rest blocks of same duration 16 seconds. In total 9 Rests and 8 Active Laser blocks. Total laser time for both HT7 was 256 seconds. Total time in scanner 15mins .
including preparation time.
6. This was a single session study. Each subject received laser acupuncture in random order (of left or right HT7 first ) followed immediately by laser acupuncture to the opposite HT7.
Intervention code [1] 256364 0
Other interventions
Intervention code [2] 256365 0
Treatment: Other
Comparator / control treatment
1. Control in each subject was active laser acupuncture to the opposite side HT7 without blockade by EMLA local aneasthetic patch.
2.Laser acupuncture intervention : Fibreoptic Continuous Beam Laser wavelength 804nm, 20mW in eight 16 second Active laser blocks, alternating with Rest blocks of same duration 16 seconds. In total 9 Rests and 8 Active Laser blocks. Total laser time for both HT7 was 256 seconds. Total time in scanner 15minutes to 20 minutes including preparation time.
Control group
Active

Outcomes
Primary outcome [1] 258299 0
Brain activation patterns with laser acupuncture to EMLA local anaesthetic patched HT7 acupoint, using MatLab and Statistical Parametric Mapping analysis (SPM).
Timepoint [1] 258299 0
At conclusion of single session where both laser acupuncture to EMLA patched HT7 and the control HT7 are carried out.
Primary outcome [2] 258325 0
Brain activation patterns with laser acupuncture to control HT7 acupoint, using MatLab and Statistical Parametric Mapping analysis (SPM).
Timepoint [2] 258325 0
At conclusion of single session where both laser acupuncture to EMLA patched HT7 and the control HT7 are carried out.
Secondary outcome [1] 264000 0
Not applicable
Timepoint [1] 264000 0
Not applicable

Eligibility
Key inclusion criteria
Healthy subject
Able to participate in MRI experiment
Able to give informed consent
Right handedness
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Past brain injury
Past injury or surgery to the upper limbs
Any intercurrent illness
Any chronic illness
Any factors contraindicated for MRI (cardiac pacemaker, metal foreign bodies, 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)
All subjects recruited were randomised to have the EMLA patch to either the left or right wrist HT7.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As this was only a small sample. allocation was by the toss of a coin.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2844 0
2031
Recruitment postcode(s) [2] 2864 0
2069

Funding & Sponsors
Funding source category [1] 256872 0
Charities/Societies/Foundations
Name [1] 256872 0
Thyne-Reid Foundation
Country [1] 256872 0
Australia
Funding source category [2] 256873 0
Other
Name [2] 256873 0
Louise Dobson and family
Country [2] 256873 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Attention: Dr Im Quah-Smith
Neuropsychiatric Institute NPI
Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 256145 0
University
Name [1] 256145 0
University of NSW
Address [1] 256145 0
School of Psychiatry
Hospital Rd
Randwick NSW 2031
Country [1] 256145 0
Australia
Other collaborator category [1] 1218 0
Individual
Name [1] 1218 0
Dr Mark Williams
Address [1] 1218 0
Macquarie Centre for Cognitive Sciences
MACCS
Macquarie University
North Ryde
NSW 2113
Country [1] 1218 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258880 0
Human Research Ethics Committee South East Health ( South East Area Health Service - SEAHS)
Ethics committee address [1] 258880 0
Ethics committee country [1] 258880 0
Australia
Date submitted for ethics approval [1] 258880 0
Approval date [1] 258880 0
10/05/2005
Ethics approval number [1] 258880 0
05073

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31098 0
Address 31098 0
Country 31098 0
Phone 31098 0
Fax 31098 0
Email 31098 0
Contact person for public queries
Name 14345 0
Dr Im Quah-Smith
Address 14345 0
LaserEmla
Albert Medical Acupuncture
5 Lord Street
Roseville
NSW 2069
Country 14345 0
Australia
Phone 14345 0
612 94156800
Fax 14345 0
612 94169743
Email 14345 0
[email protected]
Contact person for scientific queries
Name 5273 0
Prof Perminder Sachdev
Address 5273 0
Neuropsychiatric Institute
Prince of Wales Hospital
Barker Street
RandwickNSW 2031
Country 5273 0
Australia
Phone 5273 0
612 9382 3763
Fax 5273 0
612 9382 3774
Email 5273 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.