None listed
Conditions
Brief summary
As two million Australians have prediabetes and the medical expenditures are increasing, prediabetes management is a critical and challenging topic in our healthcare. People with prediabetes have a higher risk for serious health problems such as heart disease, stroke, blindness, kidney failure, loss of toes, feet, or legs. It is necessary to explore a holistic approach to prevent prediabetes from progressing to type 2 diabetes to mitigate the medical and economic burdens. By using laser light as an alternative to needles to stimulate acupuncture points, light acupuncture is a non-invasive, safer, pain-free, and non-infectious alternative to traditional acupuncture. It could be a promising add-on for prediabetes management. This study aims to evaluate the feasibility, short-term therapeutic effects, and safety of light acupuncture in prediabetes management in community settings in Western Australian (WA).
Interventions
The study will involve a 1-week run-in period, a 3-week intervention period, a 1-week washout in between intervention period, then a three-month follow-up. All participants in the intervention group will receive a light acupuncture treatment from a licensed acupuncturist at ECU Acupuncture Research Clinic. The treatment will involve a light acupuncture treatment (30-40 min/session, 5 sessions/week) for 3 weeks, within a total of 15 sessions. Each session includes preparation, treatment, and conc
The study will involve a 1-week run-in period, a 3-week intervention period, a 1-week washout in between intervention period, then a three-month follow-up. All participants in the intervention group will receive a light acupuncture treatment from a licensed acupuncturist at ECU Acupuncture Research Clinic. The treatment will involve a light acupuncture treatment (30-40 min/session, 5 sessions/week) for 3 weeks, within a total of 15 sessions. Each session includes preparation, treatment, and conclusion of the session. A 3B Laser Pen (manufacturer livetec GmbH, Marie-Curie-Str. 8, 79539 Lörrach, Germany) with the output power of 200mW and a wavelength of 808 nm will be applied to bare skin on the selected points. Each acupoint will receive 20 seconds of energy (4J), with 20 minutes being the maximum treatment time (240J). A standardised protocol for all participants will be used. The treatment points for light acupuncture are as follows: 1) Acupoints on the back: Pi Shu (BL-20), Shen Shu (BL-23), Wei Shu (BL-21), Gan Shu (BL-18), Weiwanxiashu (EX-B3), Fei Shu (BL-13), and Yi Shu (EX-B5); 2) Abdominal acupoints: Tian Shu (ST-25), Zang Men (LR 13) and Shen Que (RN8);3) Lower leg acupoints: Zu San Li (ST36), San Yin Jiao (SP-6), and Tai Xi (KI 3). During the trial process, we will use an observational sheet to monitor the adherence to the intervention.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants are eligible for this study if they meet the diagnosis criteria for prediabetes and or are scored 5 or higher on the Prediabetes Risk Test.
Exclusion criteria
People who have a greater kidney or endocrine disease, or comorbidities, or mental illness, or pregnant, preparation for pregnancy or breastfeeding or participate in another clinical trial within the last two weeks will not be eligible.
Outcome results
None listed