Table. 1. STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture).
Item | Details | |
---|---|---|
1. Acupuncture rationale | (a) Style of acupuncture | Traditional Korean medicine theory |
(b) Reasoning for treatment provided (based on historical context, literature sources and consensus methods) | Acupuncture related articles (published trials) [23-24], ‘WHO Standard Acupuncture Point Location in the Western Pacific Region’ [25] | |
(c) Extent to which treatment was varied | Two predefined acupoints | |
2. Details of needling | (a) Number of needle insertions per patient per session | Two needles |
(b) Names (or location if no standard name) of points used (uni/bilateral) | Bilateral zusanli (ST36) | |
(c) Depth of insertion | 10.0 mm (subcutaneous) | |
(d) Response sought (for example, de qi or muscle twitch response) | Deqi sensation (penetrating, sharp, aching and painful sensations when penetrating the skin, spreading and lumpish sensation around the acupuncture site) | |
(e) Needle stimulation (for example, manual, electrical) | Bidirectional rotation with the needle at 90° relative to the skin in 18 seconds to induce Deqi sensation | |
(f) Needle-retention time | 20 minutes | |
(g) Needle type (diameter, length and manufacturer or material) | 0.16 mm × 40.0 mm, stainless steel, disposable acupuncture needle (Seirin Co. Ltd., Shizuoka, Japan) | |
3. Treatment regimen | (a) Number of treatment sessions | Once |
(b) Frequency and duration of treatment sessions | Once a day | |
4. Other components of treatment | (a) Details of other interventions administered to the acupuncture group |
Not done |
(b) Setting and context of treatment, including instructions to practitioners and information and explanations to patients | Not done | |
5. Practitioner background | (a) Description of participating acupuncturists | Korean medical doctors who are specialists or resident of Korean medicine, with more than two years of clinical experience and six years of education |
6. Control or comparator interventions |
(a) Rationale for the control or comparator in the context of the research question with sources that justify this choice | Not Applicable (single-arm study) |
(b) Precise description of the control or comparator if sham acupuncture | Not Applicable (single-arm study) |