None listed
Conditions
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.
Interventions
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), w
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).
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed