Item | Detail |
---|---|
1. Acupuncture rationale | 1a) Style of acupuncture - Manual acupuncture based on traditional meridian theory. |
1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate - Based on the traditional meridian theory, clinical experience, and consensus by the experts in acupuncture and FD. | |
1c) Extent to which treatment was varied - No additional acupoints allowed. | |
2. Details of needling | 2a) Number of needle insertions per subject per session (mean and range where relevant) - Fixed 12 acupoints. |
2b) Names (or location if no standard name) of points used (uni/bilateral) - LI 4, ST36, LR3, PC3, SP4 and ST34 (bilateral) | |
2c) Depth of insertion, based on a specified unit of measurement, or on a particular tissue level - From 5 to 30 mm. | |
2d) Response sought (e.g. de qi or muscle twitch response) - ‘De qi’ sensation | |
2e) Needle stimulation (e.g. manual, electrical) - Manual acupuncture | |
2f) Needle retention time - Twenty minutes. | |
2g) Needle type (diameter, length, and manufacturer or material) - A sterilized stainless steel needle (0.25 × 40 mm, DONGBANG ACUPUNCTURE INC., Ungcheon, Boryeong, Korea). | |
3. Treatment regimen | 3a) Number of treatment sessions - Eight sessions. |
3b) Frequency and duration of treatment sessions - Twice weekly for 4 weeks, 20 min 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) - Advice for lifestyle habit included and no other interventions during the study allowed. |
4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients - Participants will be informed that the acupuncture treatment is based on traditional Korean Medicine and previous studies on clinical trial. | |
5. Practitioner background | 5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) - Korean Medicine Doctors who have license and at least 2 years of experience of treating gastrointestinal diseases. They have studied acupuncture for more than 10 years and graduated university of Korean medicine. To ensure providing identical treatments, they finished 10 h of training and simulated the 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 - No control intervention |
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. |