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Item | Detail |
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(1) Acupuncture Rationale | (1a) Style of acupuncture |
(i) MA and IA using PTN based on traditional meridian theory |
(1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate |
(i) Partially individualized MA treatment and IA treatments based on the traditional meridian theory, clinical experience, and consensus by the experts in acupuncture and AD |
(1c) Extent to which treatment was varied |
MA: Partially individualized, that is, 6 fixed points plus optional points according to individual symptoms |
IA: Fixed treatment |
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(2) Details of Needling | (2a) Number of needle insertions per subject per session (mean and range where relevant) MA: 6 to 19 body acupoints per participant per session IA: 2 body acupoints and 1 auricular acupoint per participant per session (2b) Names (or location if no standard name) of points used (uni/bilateral) MA: |
(i) fixed points: PC6, LI11, ST36 bilaterally |
(ii) optional points: ST43, GB11, LI2, TE3, TE6, SI2, SI3, BL66, LR3, SP3 contralaterally (GB41, TE3, SI3 can be applied bilaterally according to the signs or symptoms of the patient) |
IA: LI11 bilaterally and auricular shenmen contralaterally |
(2c) Depth of insertion, based on a specified unit of measurement or on a particular tissue level MA: From 5 to 30 mm, perpendicular to skin surface IA: 1.5 mm, perpendicular to skin surface (2d) Response sought (e.g., de qi or muscle twitch response) MA: “de qi” sensation IA: None (2e) Needle stimulation (e.g., manual, electrical) MA: Manual stimulation, needle rotation with thumb and index fingers for the first 10-15 seconds IA: Participants will be educated to press PTNS at LI11 for more than 3 minutes when they feel severe itching (2f) Needle retention time MA: 15 minutes IA: 1-2 days until PTN falls off (2g) Needle type (diameter, length, and manufacturer or material) MA: A sterilized stainless steel needle (0.25 x 40 mm, Dongbang Acupuncture Inc., Bundang, Seongnam, Korea) IA: A hypoallergic PTN (1.5 mm, 10 x 10 mm adhesive tape, Haeng Lim Seo Won Medical Co., Korea) |
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(3) Treatment Regimen | (3a) Number of treatment sessions |
(i) 8 sessions |
(3b) Frequency and duration of treatment sessions |
(i) Twice a week for 4 weeks, 15 minutes for each session |
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(4) Other Components of Treatment | (4a) Details of other interventions administered to the acupuncture group (e.g. moxibustion, cupping, herbs, exercises, lifestyle advice) |
(i) Lifestyle advice will be given to all participants |
(ii) Any other interventions will be prohibited during study period |
(4b) Settings and context of treatment, including instructions to practitioner and information and explanations to patients |
(i) Participants will be informed about acupuncture treatment in the study as follows: “In this study, you will be randomly allocated to VA group or SA group. Acupoints will be selected based on traditional Korean medicine textbook and AD-related reports. Also, additional acupoints can be used according to individual conditions, if needed.” |
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(5) Practitioner Background | (5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) |
(i) KMD who has clinical experience in Korean Medicine dermatology more than 2 years. The practitioner KMD will have undergone more than 10 hours of training and simulation workshop to ensure that he is able to provide identical acupuncture treatment in accordance with a predefined protocol. |
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(6) Control and Comparator Interventions | (6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice |
(i) A control group (SA) will be treated with sham acupuncture using Park sham acupuncture needles and nonpenetrating sham PTNs |
(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 |
MA: Park sham acupuncture needles and devices will be used in same environment as in the VA group. However, fixed acupoints will be different: a point 1 to 2 cm proximal and 1 cm medial to LI7, a point 1 cm proximal and 1 cm medial to LI11, and a point 1 cm proximal and 1 cm lateral to ST36, each bilaterally |
IA: Nonpenetrating sham PTNs, which were designed and validated for blinding for our study, will be used as a control in same environment as in the VA group. The same sized stainless steel rings without needles will be attached to three control points: a point 1 cm proximal and 1 cm medial to LI11, bilaterally, and finger point in the ear contralaterally. |
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