|1. Acupuncture rationale||1a) Style of acupuncture||Manual acupuncture based on traditional Korean medicine theory|
|1b)Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate||Consensus of the KMD|
|1c)Extent to which treatment was varied||All participants will receive standardized treatment|
|2. Details of needling||2a) Number of needle insertions per subject per session||1|
|2b) Names of points used||Left ST36|
|2c) Depth of insertion, based on a specified unit of measurement||15 mm|
|2d) Response sought||De-qi|
|2e) Needle stimulation :||During 3 min of phasic session, manual stimulation will be conducted eight times based on an audio signal received via a headphone. Interval between each manual stimulation is from 10 to 14 s. For each manual stimulation, the acupuncture needle will be rotated five times during 3 s.|
|2f) Needle retention time||11 min|
|2g) Needle type||[Group 1] Real Streitberger’s needle; 0.25 × 40 mm sterilized stainless steel needle (Asia-med GmbH & Co. KG, Kirchplatz 1, Germany).|
|[Group 2] PSD; 0.25 × 40 mm sterilized stainless steel needle (Park sham Device, Acuprime, Exter, UK).|
|3. Treatment regimen||3a) Number of treatment sessions||3 sessions|
|3b) Frequency and duration of treatment sessions||3 sessions for 1 day|
|(30 min washout period between each session)|
|4. Other components of treatment||4a) Details of other interventions administered to the acupuncture group||None|
|4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients||The study will be conducted in the Kyung Hee University Medical Center. All information except the objective of trial and acupuncture types will be provided to the participants.|
|5. Practitioner background||5) Description of participating acupuncturists||Licensed KMD with at least 5 years of clinical practice experience|
|6. Control interventions||6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice||Validated placebo acupuncture devices will be used in control sessions.|
|6b) Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-like control is used, provide details as for Items 1 to 3 above.||The order of three treatments in each group will be randomized.|
1) Sham Streitberger’ needle: 0.25 × 40 mm sterilized stainless steel needle (Special No. 16 of Asia-med GmbH & Co. KG, Kirchplatz 1,Germany) will be used.
The appearance, acupuncture point, stimulation method, and duration will be the same with the real Streitberger’s needle.
|2) Phantom acupuncture: There is no tactile stimulation to ST 36. To induce credibility that participants are treated with acupuncture, the video clip of the previously recorded Streitberger’s needle session will be shown.|
1) PSD with sham needle: 0.25 × 40 mm sterilized stainless steel needle (Park sham Device, Acuprime, Exter, UK) will be used. The appearance, acupuncture point, stimulation method, and depth will be the same with the PSD as with the real needle. 2) No treatment: There is no acupuncture treatment. To induce the attention effect as in the other sessions, a neutral image will be provided instead of an acupuncture treatment image.