Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000350729p
Ethics application status
Submitted, not yet approved
Date submitted
27/01/2022
Date registered
25/02/2022
Date last updated
25/02/2022
Date data sharing statement initially provided
25/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of low-level laser acupuncture for primary dysmenorrhea in women
Scientific title
Feasibility and therapeutic effect of low-level laser acupuncture for women with primary dysmenorrhea: a pilot, single-blind, double-armed, randomised controlled trial
Secondary ID [1] 306287 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary dysmenorrhea 325048 0
Condition category
Condition code
Alternative and Complementary Medicine 322483 322483 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 322484 322484 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group:
In addition to usual care, participants will receive low-level laser acupuncture (LLLA) from a licensed acupuncturist at ECU Holistic Health Research Clinic, 30-40 minutes per session, including preparation, intervention, and conclusion of the intervention. A 3B laser pen (200 mW, Germany) will be used for intervention with a wavelength of 808 nm in continuous wave mode to be applied to bare skin on the selected acupoints. Each point will receive 20 seconds of energy (4J), with 20 minutes being the maximum treatment time (240J). Participants will be treated once every second day, and the treatment starts seven days before the commencement of the menstrual cycle until the end of the cycle. Two consecutive menstrual cycles will be administrated, and 12 sessions in total. Participants' compliance and adherence will be assessed via an observational sheet during intervention cycle 1 and intervention cycle 2.
Based on previous studies and Delphi consensus, we identified eight candidate acupoints for the intervention treatment, namely Sanyinjiao (SP6), Diji (SP8), Guanyuan (CV4), Hegu (LI4), Ciliao (BL32), Guilai (ST29), Taichong (LR3), Zigong (EX-CA1).
Intervention code [1] 322719 0
Treatment: Devices
Comparator / control treatment
Control group:
Participants in the control group will receive usual care only. Usual care in this instance refers to routine pain management without any form of acupuncture, such as diet, exercise, rest, or medication if applicable. The participants will be provided with complimentary acupuncture treatment after the two menstrual cycles follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 330270 0
Recruitment and completion rate: the number of participants referred, eligible, enrolled, withdrawn, and completed will be recorded. The recruitment rate will be audited by dividing the number of consented people by the number of eligibilities, while the completion rate will be evaluated by dividing the number of completion by the number of enrollment.
Timepoint [1] 330270 0
This outcome will be assessed at post-intervention (after completion of 12 treatment sessions) (T1).
Primary outcome [2] 330534 0
Participant compliance and adherence: participants' sessions attendance, completed sessions, missed sessions, and arranging appointments will be recorded via observational sheets.
Timepoint [2] 330534 0
This outcome will be assessed during intervention (both cycle 1 and cycle 2).
Primary outcome [3] 330535 0
Non-pharmacological therapy preference in the past three months via study-specific online surveys.
Timepoint [3] 330535 0
This outcome will be assessed at baseline (T0).
Secondary outcome [1] 405542 0
Primary outcome: The number and severity of adverse events (AEs). Details (number, types, and severity) and potential reasons will be recorded via observational sheets if any AEs (irritation, bruises, myalgia, et al) occur during the intervention. Before starting the treatment, we will also ask questions about AEs of previous participation.
Timepoint [1] 405542 0
This outcome will be assessed during intervention (both cycle 1 and cycle 2).
Secondary outcome [2] 406537 0
Primary outcome: Enabling and disabling factors: for example, the participants’ attitudes, motivation, challenges to participation, and their trial experience. This outcome will be investigated qualitatively via open-ended questions using study-specific online surveys.
Timepoint [2] 406537 0
This outcome will be assessed at baseline (T0), post-intervention (after completion of 12 treatment sessions) (T1), and follow-up (two more cycles post intervention) (T2).
Secondary outcome [3] 406538 0
Primary outcome: The 3-monthly out-of-pocket (OOP) cost for pharmacological and non-pharmacological PD therapies will be investigated via study-specific online surveys.
Timepoint [3] 406538 0
This outcome will be assessed at baseline (T0).
Secondary outcome [4] 406539 0
Pain assessment: Visual analogue scale (VAS) and Short-Form McGill Pain Questionnaire (SF-MPQ) will be used to measure the pain through online surveys .
Timepoint [4] 406539 0
This outcome will be assessed at the baseline (T0), post-intervention (after completion of 12 treatment sessions) (T1), and follow-up (two more cycles post intervention) (T2) of this trial.
Secondary outcome [5] 406540 0
Mental wellbeing: The self-rating anxiety scale (SAS) and the self-rating depression scale (SDS) via online surveys.
Timepoint [5] 406540 0
This outcome will be assessed at baseline (T0), post-intervention (after completion of 12 treatment sessions) (T1), and follow-up (two more cycles post intervention) (T2).
Secondary outcome [6] 406541 0
Quality of life: The 12-item Short-Form Health Survey (SF-12) will be used to assess the status of general physical health via online surveys.
Timepoint [6] 406541 0
This outcome will be assessed at baseline (T0), post-intervention (after completion of 12 treatment sessions) (T1), and follow-up (two more cycles post intervention) (T2).

Eligibility
Key inclusion criteria
1) Diagnosed with PD by the general practitioner (GP) based on a history of cramping pain during menstruation and physical examination with normal findings; 2) aged between 18 and 40 years; 3) with regular menstrual cycles (28±7 days) for the past three months; 4) course of dysmenorrhea at least six months; 5) experiencing an average menstrual pain visual analog scale (VAS) score of more than 4cm during screening; 6) ability to read and write in English; 7) agree to complete the questionnaires; (8) willing and capable of giving consent.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Secondary dysmenorrhea; 2) allergic to light; 3) uncontrolled psychiatric disorders, or other symptoms of unknown cause; 4) women in lactation, or those planning to become pregnant.

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)
The block sizes will not be disclosed to ensure concealment. The allocation will be performed by an independent, blinded statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence number of each participant will be computer generated using a randomized block approach.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data analysis will be performed by independent statisticians who are blinded to the entire allocation and intervention process using R.
The primary analysis of this pilot trial will focus on the outcomes assessing feasibility by descriptive analysis. The number and the proportion of participants recruited, screened, consented and randomized will be presented. The characteristics of participants, non-pharmacological therapy preference, number and reasons for withdrawals from the trial, and adverse events will be summarized for each group. Qualitative data, such as participants’ attitudes, motivation, and challenges to participation, and their trial experience will be analyzed qualitatively to provide valuable insight on the enabling and disabling factors.
For the secondary outcome, a linear mixed model will be used to assess the pre-post-intervention data through R to detect the effects of the intervention versus the control groups. Statistical significance will be set at an alpha level of 0.05. Gender, age, or other relevant confounding factors will be adjusted for all models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310636 0
University
Name [1] 310636 0
Edith Cowan University
Country [1] 310636 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 311848 0
None
Name [1] 311848 0
Address [1] 311848 0
Country [1] 311848 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310237 0
Edith Cowan University's Human Research Ethics Committee
Ethics committee address [1] 310237 0
270 Joondalup Dr Joondalup WA 6027
Ethics committee country [1] 310237 0
Australia
Date submitted for ethics approval [1] 310237 0
24/01/2022
Approval date [1] 310237 0
Ethics approval number [1] 310237 0

Summary
Brief summary
Primary dysmenorrhea (PD) is a common menstrual complaint with a high prevalence and significantly impacts physical and mental health. Low-level laser acupuncture (LLLA) has been used in a few health conditions with positive outcomes. However, the evidence in the use of LLLA for PD is still limited and inconclusive. LLLA is a non-invasive, painless, and safe modality that could be an option for PD management. This study aims to investigate the feasibility and therapeutic effect of LLLA for manage PD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116954 0
Ms Weiting Liu
Address 116954 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 116954 0
Australia
Phone 116954 0
+61 863043589
Fax 116954 0
Email 116954 0
weitingl@our.ecu.edu.au
Contact person for public queries
Name 116955 0
Ms Weiting Liu
Address 116955 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 116955 0
Australia
Phone 116955 0
+61 863043589
Fax 116955 0
Email 116955 0
weitingl@our.ecu.edu.au
Contact person for scientific queries
Name 116956 0
Ms Weiting Liu
Address 116956 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 116956 0
Australia
Phone 116956 0
+61 863043589
Fax 116956 0
Email 116956 0
weitingl@our.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
No additional documents have been identified.