ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

shoulder pain

neck pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Public Health

Epidemiology

Alternative and Complementary Medicine

Other alternative and complementary medicine

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Injuries and Accidents

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]

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]

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]

Baseline, between intervention, and two weeks after intervention commencement

Secondary outcome [1]

Pain assessed by the Visual analogue scale (VAS) and the Short-Form McGill Pain Questionnaire (SF-MPQ)

Timepoint [1]

Baseline and two weeks after intervention commencement

Secondary outcome [2]

Work productivity and activity assessed by the Work Productivity and Activity Impairment Questionnaire for Specific Health Problem V2.0 (WPAI:SHP)

Timepoint [2]

Baseline and two weeks after intervention commencement

Secondary outcome [3]

Quality of life assessed by the 12-item Short Form Health Survey (SF-12)

Timepoint [3]

Baseline and two weeks after intervention commencement

Secondary outcome [4]

3-monthly out of pocket cost for prescription and non-prescription SNP therapies assessed via questionnaire

Timepoint [4]

Baseline

Secondary outcome [5]

Past 3-month choice of non-pharmacologic therapy assessed via questionnaire

Timepoint [5]

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?

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)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

270 Joondalup Dr Joondalup WA 6027

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

270 Joondalup Dr. Joondalup WA 6027

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Edith Cowan University’s Human Research Ethics Committee

Ethics committee address [1]

270 Joondalup Dr Joondalup WA 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/03/2021

Approval date [1]

Ethics approval number [1]

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

Dr Carol Chunfeng Wang

Address

Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Contact person for public queries

Name

Carol Chunfeng Wang

Address

Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Contact person for scientific queries

Name

Carol Chunfeng Wang

Address

Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Feasibility 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.	2022	https://dx.doi.org/10.1371/journal.pone.0260846

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically