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Table 2 Details of acupuncture treatments based on the STRICTA 2010 checklist

From: Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial

Item

Detail

1. Acupuncture rationale

1a) Style of acupuncture

Electroacupuncture 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

Based on consensus of the KMD, clinical experience, traditional acupuncture, meridian theory, and experimental/clinical articles

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

12

2b) Names of points used

bilateral PC5, PC6, ST36, ST37, KI3, and SP6

2c) Depth of insertion, based on a specified unit of measurement

1.5 ± 0.5 cm

2d) Response sought

De-qi

2e) Needle stimulation

:

Electrical stimulation with a frequency of 2 Hz, 400 μs per stimulation (ES-160, ITO, Japan)

2f) Needle retention time

20 min

2 g) Needle type

Park Sham Device (PSD) with a real needle; 0.20 mm × 40 mm sterilized stainless steel needle (Park Sham Device, Acuprime, Exeter, UK).

3. Treatment regimen

3a) Number of treatment sessions

5 sessions

3b) Frequency and duration of treatment sessions

1 sessions per day for 5 days

4. Other components of treatment

4a) Details of other interventions administered to the acupuncture group

Conventional Western medicine management according to guideline: diuretics, nitroglycerin, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta blockers, aldosterone antagonists, ivabradine

4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients

The study will be conducted at the Kyung Hee University Medical Center. All patients will be admitted to the cardiac ward for treatment of acute heart failure. All information except patient allocated group will be provided to participants.

5. Practitioner background

5) Description of participating acupuncturists

Licensed KMDs with at least 2 years of clinical practice. The practitioners have studied acupuncture for more than 8 years and graduated from the University of Korean Medicine. Standardized operation procedures were written for practitioners to ensure identical treatments.

6. Control interventions

6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice

Based on consensus of the KMD, clinical experience, traditional acupuncture and meridian theory, and experimental/clinical articles

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.

For the control group, bilateral LI6, LI7, GB37, GB39, BL58 and BL59 will be stimulated 20 min per day for 5 days using PSD with a sham needle (0.25 mm × 40 mm sterilized stainless steel needle) that cannot penetrate the skin. It will be connected to an electrical stimulator without an electrical current.

  1. Abbreviations: KMD Korean Medicine Doctor, PSD park sham device