Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000426886p
Ethics application status
Submitted, not yet approved
Date submitted
6/02/2021
Date registered
16/04/2021
Date last updated
26/11/2021
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Is laser acupuncture an effective treatment for shoulder and neck pain in office workers?
Scientific title
The feasibility and therapeutic efficacy of a two-week low-level laser acupuncture therapy for shoulder and neck pain in office workers: a single-blind, double-armed, randomised controlled trial
Secondary ID [1] 303371 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 320635 0
neck pain 320997 0
Condition category
Condition code
Musculoskeletal 318492 318492 0 0
Other muscular and skeletal disorders
Public Health 318493 318493 0 0
Epidemiology
Alternative and Complementary Medicine 318494 318494 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 318495 318495 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 318496 318496 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group:
In addition to usual care, participants will receive LLLA from a licensed acupuncturist at ECU Acupuncture Research Clinic. 10-20 minutes per session, three times a week for two weeks. The parameters of 3B Laser Pen (200mW) used for the intervention are wavelength of 808 nm in continuous wave mode, each pressure point receives 20 seconds of energy (4J) with 5 minutes being the maximum treatment time (60 J). At the end of two weeks receiving the therapy, participants will receive an online link to complete the post-intervention questionnaires.
Intervention code [1] 319680 0
Treatment: Other
Comparator / control treatment
Control group:
Non-intervention control group with usual care only. Usual care in this instance includes the routine care received by participants for management of SNP, for example, exercise, rest, or take medication.
Control group
Active

Outcomes
Primary outcome [1] 326449 0
The primary outcome for this study is feasibility of the two weeks LLLA therapy for office workers with SNP. Feasibility will be assessed by measuring: 1) recruitment and completion rates (No. of referred, No. of eligible, No. of enrolled, No. of withdrawals, trial recruitment rate, and trial completion rate), 2) patient safety (No. and severity of adverse events), and 3) treatment adherence (No. of completed sessions and missed sessions). Participants’ motivation and challenges to participation, withdrawal, missed sessions and non-compliance to intervention will be investigated, as will their attitude, and experience in participating the trial.
Timepoint [1] 326449 0
Baseline, between intervention, and two weeks after intervention commencement
Secondary outcome [1] 391529 0
Pain assessed by the Visual analogue scale (VAS) and the Short-Form McGill Pain Questionnaire (SF-MPQ)
Timepoint [1] 391529 0
Baseline and two weeks after intervention commencement
Secondary outcome [2] 392563 0
Work productivity and activity assessed by the Work Productivity and Activity Impairment Questionnaire for Specific Health Problem V2.0 (WPAI:SHP)
Timepoint [2] 392563 0
Baseline and two weeks after intervention commencement
Secondary outcome [3] 392564 0
Quality of life assessed by the 12-item Short Form Health Survey (SF-12)
Timepoint [3] 392564 0
Baseline and two weeks after intervention commencement
Secondary outcome [4] 392565 0
3-monthly out of pocket cost for prescription and non-prescription SNP therapies assessed via questionnaire
Timepoint [4] 392565 0
Baseline
Secondary outcome [5] 392566 0
Past 3-month choice of non-pharmacologic therapy assessed via questionnaire
Timepoint [5] 392566 0
Baseline

Eligibility
Key inclusion criteria
1) aged between 18-65 years
2) working more than 28 h a week with sedentary office work
3) moderate to severe SNP (VAS > 5/10 & SF-MPQ > 2/45) for more than three months
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant, people with cancer, high sensitivity to light, or other symptoms of unknown cause will not be eligible.

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 potential participants will be provided with an online information sheet and consent form outlining what will be involved in the trial. People who gave consent will complete a set of online questions. The recruitment will continue until the required number is reached.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will then be randomised via survey software (Qualtrics) to one of the two groups by a statistician who is blinded to the identity of the individuals.
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
Parallel
Other design features
Participants will be randomly allocated to one of the two groups:
1. in addition to usual care, receive six laser acupuncture treatment sessions from a licensed acupuncturist at ECU Acupuncture Research Clinic. Or
2. receive NO treatment but usual care over two weeks’ trial time
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of the pre- post-intervention data will consist of Generalised Linear Mixed Modelling through R software to detect effects of the intervention versus the control groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2021
Actual
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
30/08/2022
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 307785 0
University
Name [1] 307785 0
Edith Cowan University
Country [1] 307785 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr. Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 308493 0
None
Name [1] 308493 0
Address [1] 308493 0
Country [1] 308493 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307802 0
Edith Cowan University’s Human Research Ethics Committee
Ethics committee address [1] 307802 0
270 Joondalup Dr Joondalup WA 6027
Ethics committee country [1] 307802 0
Australia
Date submitted for ethics approval [1] 307802 0
25/03/2021
Approval date [1] 307802 0
Ethics approval number [1] 307802 0

Summary
Brief summary
Shoulder and neck pain (SNP) are common and burdensome conditions in office workers with a high prevalence. It is a serious public health problem and has a significant detrimental impact on one’s quality of life, physical functioning, economic structure, families, employers and health care system.
Lengthened working hours on the computer, prolonged sitting position, and static postures are the most contributing factors, and medication and physiotherapy were the most common intervention strategies that people chose to manage their pain.
The low-level laser therapy (LLLT), also known as cold laser, photobiomodulation, applies specific wavelengths and low power density, has been shown to be an additional option in the SNP management to relive pain and re-establish quality of life. LLLT can promotes analgesic and anti-inflammatory effects, improve blood circulation, boosts immunity and speeds up wound healing, with no reported adverse effects and well received by many patients.
Low-level laser acupuncture (LLLA), is one of the recent technological developments (e.g., electroacupuncture) in the practice of acupuncture, which integrate the cutting-edge laser technology and thousands of years old TCM modality. Instead of the needle stimulation on the acupuncture points, low intensity non thermal laser irradiation is applied to elicit the cellular level’s physiologic effects with sufficient energy. It is, therefore, non-invasive, painless, non-infectious and safe to use. LLLA has become increasingly attractive for patients with needle phobias, older people and children.
Several studies demonstrated that LLLA is a promising modality in pain management. However, there is no consolidated evidence for LLLA in managing shoulders and neck pain, and more studies in this field are required to provide updated evidence. Therefore, this study aims to provide compelling evidence of the feasibility and therapeutic efficacy of LLLA for office workers with SNP.
We anticipate, based on past research, the LLLA we will provide may be helpful in reducing levels of SNP. We hope that the results of our research can be used to inform our knowledge about how to better manage SNP that many office workers are suffering.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108550 0
Dr Carol Chunfeng Wang
Address 108550 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 108550 0
Australia
Phone 108550 0
+61 8 63043589
Fax 108550 0
Email 108550 0
c.wang@ecu.edu.au
Contact person for public queries
Name 108551 0
Dr Carol Chunfeng Wang
Address 108551 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 108551 0
Australia
Phone 108551 0
+61 8 63043589
Fax 108551 0
Email 108551 0
c.wang@ecu.edu.au
Contact person for scientific queries
Name 108552 0
Dr Carol Chunfeng Wang
Address 108552 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 108552 0
Australia
Phone 108552 0
+61 8 63043589
Fax 108552 0
Email 108552 0
c.wang@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseFeasibility and therapeutic efficacy of a twoweek low-level laser acupuncture therapy for shoulder and neck pain in office workers: Protocol for a pilot, single-blind, doublearmed, randomised controlled trial.2022https://dx.doi.org/10.1371/journal.pone.0260846
N.B. These documents automatically identified may not have been verified by the study sponsor.