Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000337471
Ethics application status
Approved
Date submitted
17/02/2025
Date registered
22/04/2025
Date last updated
22/04/2025
Date data sharing statement initially provided
22/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brain and Movement Function: A Study on Laser Acupuncture in Healthy Adults
Scientific title
Effect of Laser Acupuncture on Corticospinal Excitability and Sensorimotor Function in Healthy Adults: A Randomized Single-Blind Sham-Controlled Trial
Secondary ID [1] 313987 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
brain function 336711 0
sensorimotor function 336979 0
Condition category
Condition code
Alternative and Complementary Medicine 333211 333211 0 0
Other alternative and complementary medicine
Neurological 333212 333212 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 333213 333213 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laser acupuncture is a non-invasive therapeutic technique that applies low-level laser therapy (LLLT) to acupuncture points to stimulate physiological responses. This technique uses a laser applicator that emits low-level laser light when applied directly to the skin surface of specific acupuncture points. The participant will remain seated comfortably during the treatment.

A low-level laser device will be used to irradiate motor-related acupuncture points including Hegu (LI4), Quchi (LI11), and Shousanli (LI10). Each acupoint will receive 5 minutes of continuous laser stimulation per session.

The parameters of the laser device are as follows:

Wavelength: 808 nm

Power output: 100 mW

Energy density: 4 J/cm² per point

Mode: Continuous wave

Each participant will receive four laser acupuncture sessions in total. Each complete session will last approximately 120 minutes, including pre- and post-treatment assessments.

The intervention will be delivered face-to-face in a controlled university research laboratory by a trained acupuncturist experienced in both traditional acupuncture and laser therapy. Standardized treatment protocols will be strictly followed to ensure consistency across sessions. Session fidelity will be assessed through direct observation, and adherence will be monitored by trained research personnel.

A 48-hour washout period will be implemented between different treatment conditions in accordance with the crossover trial design.
Intervention code [1] 330574 0
Prevention
Intervention code [2] 330739 0
Treatment: Devices
Comparator / control treatment
A sham laser acupuncture control will be used, where the same laser device is applied to the same acupoints without actual laser emission to maintain blinding.
Control group
Placebo

Outcomes
Primary outcome [1] 340784 0
Corticospinal excitability
Timepoint [1] 340784 0
Each intervention session includes a pre-treatment assessment, the intervention, and an immediate post-treatment assessment. A 48-hour washout period is applied between sessions. The primary timepoints are immediately before and after each intervention session (i.e., pre- and post-intervention assessments for all four conditions, each separated by a 48-hour washout period).
Secondary outcome [1] 445070 0
manual dexterity
Timepoint [1] 445070 0
Each intervention session includes a pre-treatment assessment, the intervention, and an immediate post-treatment assessment. A 48-hour washout period is applied between sessions.
Secondary outcome [2] 446519 0
Fine motor skills
Timepoint [2] 446519 0
Each intervention session includes a pre-treatment assessment, the intervention, and an immediate post-treatment assessment. A 48-hour washout period is applied between sessions.
Secondary outcome [3] 446520 0
Coordination
Timepoint [3] 446520 0
Each intervention session includes a pre-treatment assessment, the intervention, and an immediate post-treatment assessment. A 48-hour washout period is applied between sessions.

Eligibility
Key inclusion criteria
Participants were eligible if they were between the ages of 18 and 40, had normal cognitive function, no history of neurological or psychiatric conditions, no contraindications to or TMS, and were not taking neuroactive medications.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included the presence of metallic implants in the head, indwelling body stimulators, a history of seizures, or current pregnancy.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
Actual
1/12/2024
Date of last data collection
Anticipated
Actual
15/02/2025
Sample size
Target
16
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318489 0
University
Name [1] 318489 0
Monash Univeristy
Country [1] 318489 0
Australia
Primary sponsor type
Individual
Name
Renming Liu (Monash University)
Address
Country
Australia
Secondary sponsor category [1] 320883 0
University
Name [1] 320883 0
Monash University
Address [1] 320883 0
Country [1] 320883 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317099 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317099 0
Ethics committee country [1] 317099 0
Australia
Date submitted for ethics approval [1] 317099 0
09/01/2024
Approval date [1] 317099 0
06/03/2024
Ethics approval number [1] 317099 0

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

Contacts
Principal investigator
Name 139990 0
Dr Renming.Liu
Address 139990 0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Country 139990 0
Australia
Phone 139990 0
+61 0426227757
Fax 139990 0
Email 139990 0
[email protected]
Contact person for public queries
Name 139991 0
Renming.Liu
Address 139991 0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Country 139991 0
Australia
Phone 139991 0
+61 0426227757
Fax 139991 0
Email 139991 0
[email protected]
Contact person for scientific queries
Name 139992 0
Renming.Liu
Address 139992 0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Country 139992 0
Australia
Phone 139992 0
+61 0426227757
Fax 139992 0
Email 139992 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Studies exploring new research questions
When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24553Ethical approval    ethics.pdf


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.