Table 1.
Item | Detail |
---|---|
1. Acupuncture rationale |
1a) Style of acupuncture Manual and electro-acupuncture base on traditional Chinese medicine theory and evidences from previous clinical trials. |
1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate According to systematic reviews and clinical experiences of our principal investigator and co-investigators. | |
1c) Extent to which treatment was varied Standard treatment is used. No variation of treatment among patients. | |
2. Details of needling |
2a) Number of needle insertions per subject per session (mean and range where relevant) 15 needles. |
2b) Names (or location if no standard name) of points used (uni/bilateral) Bilateral—Tianshu (ST25), Zusanli (ST36), Sanyinjiao (SP6), Toulinqi (GB15), Taichong (LR3), and Zhangmen (LR13). Unilateral—Baihui (GV20), Guanyuan (CV4), and Zhongwan (CV12). | |
2c) Depth of insertion, based on a specified unit of measurement, or on a particular tissue level 10–30 mm. | |
2d) Response sought (e.g.,de qior muscle twitch response) De qi. | |
2e) Needle stimulation (e.g., manual, electrical) Manual. Electrical—dense-disperse waves with 50 Hz at 10 volts. | |
2f) Needle retention time 30 min. | |
2g) Needle type (diameter, length, and manufacturer or material) Disposable stainless steel acupuncture needles (Dong Bang acupuncture needles, 0.25 mm in diameter and 40 mm in length with guide tube, manufactured by Dong Bang Acupuncture Inc. Korea). | |
3. Treatment regimen |
3a) Number of treatment sessions 12 sessions. |
3b) Frequency and duration of treatment sessions 2/week for 6 consecutive weeks. | |
4. Other components of treatment |
4a) Details of other interventions administered to the acupuncture group (e.g., moxibustion, cupping, herbs, exercises, lifestyle advice) None. |
4b) Setting and context of treatment, including instructions to practitioners and information and explanations to patients University clinics. Participants will be informed about acupuncture treatment in the study as follows: “In this study, acupoints for IBS will be used based on related reports and clinical experience of our investigators.” | |
5. Practitioner background |
5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experiences) Hong Kong-registered Chinese medicine practitioners having at least 3 years of clinical experience, who have undergone training and are able to provide identical acupuncture treatment in accordance with a pre-defined 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 To assess the efficacy and safety of electro-acupuncture compared to sham acupuncture. |
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 - Style of acupuncture: sham acupuncture (needling at sham acupoints). - Number of needle insertions per subject per session: 15 needles. - Depth of insertion: 10–30 mm. - Needle retention time: 30 min. - Needle type: the same as the treatment group. - Number of treatment sessions: 12 sessions. - Frequency and duration of treatment sessions: 2/week for 6 consecutive weeks. |
Note: This checklist, which should be read in conjunction with the explanations of the STRICTA items, is designed to replace CONSORT 2010’s item 5 when reporting an acupuncture trial