| | Item | Detail |
| | (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 individualised MA treatments 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 individualised, that is, fixed points plus optional points according to symptoms
IA: Fixed treatment |
| | (2) Details of needling | (2a) Number of needle insertions per subject per session (mean and range where relevant)
MA: From 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, GB41, 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 for 3 seconds when they feel severe itch
(2f) Needle retention time
MA: 15 minutes
IA: 1-2 days or until PTN falls off
(2g) Needle type (diameter, length, and manufacturer or material)
MA: A sterilised stainless steel needle (0.25 × 40 mm, Dongbang Acupuncture Inc., Bundang, Seongnam, Korea)
IA: A hypoallergenic PTN (1.5 mm, 10 × 10 mm adhesive tape, Haeng Lim Seo Won Medical Co., Korea) |
| | (3) Treatment regimen | (3a) Number of treatment sessions
(i) 8 or 12 sessions according to the allocated group
(3b) Frequency and duration of treatment sessions
(i) Twice or 3 times a week for 4 weeks, 20 minutes for each session |
| | (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 advices will be given to all participants
(ii) Corticosteroids will be allowed as a rescue medicine of severe pruritus through the consensus of the KMD in charge of this study and the pharmacist working for Kyung Hee University Korean Medicine Hospital
(4b) Setting and context of treatment, including instructions to practitioner and information and explanations to patients
(i) A university hospital
(ii) Participants will be informed about acupuncture treatment in the study as follows: “In this study, you will be randomly allocated to verum acupuncture treatment or sham acupuncture treatment and acupoints for AD will be selected based on traditional Korean medicine textbook and AD-related reports. Also, additional acupoints can be used according to individual conditions.” |
| | (5) Practitioner background | (5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience)
(i) A KMD who has a license and at least two years of clinical experience in dermatologic disorders. He attended 10 hours of training and simulation workshop to ensure that he is able to provide identical acupuncture treatment in accordance with a predefined protocol |
| | (6) Control or 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 will be treated with sham acupuncture, that is, 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 an identical manner as in the verum acupuncture groups. However, fixed acupuncture treatments will be given to 6 control points: 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 an identical manner as in the verum acupuncture groups. The same sized stainless steel rings without needles, that is, nonpenetrating sham, which were designed and validated for blinding for our study, 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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