Research Article

Acupuncture Treatment for Symptom Management in Atopic Dermatitis: A Study Protocol for a Randomized, Participant- and Assessor-Blind, Sham-Controlled Trial

Table 1

Acupuncture treatment details based on the checklist for STRICTA 2010. STRICTA: Standards for Reporting Interventions in Clinical Trials of Acupuncture; MA: Manual Acupuncture; IA: Intradermal Acupuncture; PTN: Press Tack Needle; AD: Atopic Dermatitis; VA: Verum Acupuncture; SA: Sham Acupuncture; KMD: Korean Medicine Doctor.

ItemDetail

(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

(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)

(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

(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.”

(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.

(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.