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 | 20Â 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 5Â 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 2Â years of clinical practice. The practitioners have studied acupuncture for more than 8Â 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. |