From: Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial
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 | |
- Partially-individualized manual acupuncture treatments based on the traditional meridian theory, clinical experience, and consensus by the experts in acupuncture and FD. | |
1c) Extent to which treatment was varied | |
- Partially-individualized acupuncture treatment, i.e., fixed points plus optional points according to symptoms. | |
2. Details of needling | 2a) Number of needle insertions per subject per session (mean and range where relevant) |
- From 9 to 19. | |
2b) Names (or location if no standard name) of points used (uni/bilateral) | |
- Nine fixed points: LI4, ST36, LR3, and SP4 (bilateral) and CV12 (unilateral). | |
- Optional points according to individual symptoms: GB21, SI14, PC6, EX-HN5, 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 stimulation: needle rotation with thumb and index fingers at 3 Hz. | |
2f) Needle retention time | |
- Fifteen minutes. | |
2g) Needle type (diameter, length, and manufacturer or material) | |
- A sterilized stainless steel needle (0.25?×?40 mm, Dongbang Acupuncture Inc., Bundang, Sungnam, Korea). | |
3. Treatment regimen | 3a) Number of treatment sessions |
- Eight treatment sessions in both acupuncture and waitlist groups. | |
3b) Frequency and duration of treatment sessions | |
- Twice weekly for 4 weeks, 15 minutes 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) |
- No other interventions during the study period allowed. | |
4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | |
- University hospitals. | |
- Participants will be informed about acupuncture treatment in the study as follows: “In this study, acupoint for FD will be used based on traditional Korean medicine textbook and FD-related reports.” | |
5. Practitioner background | 5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) |
- Korean Medicine Doctors who have a license and at least 3 years of experience in gastrointestinal disorders. They went through 10 hours of training and simulation to ensure that they 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 |
- A waitlist group will be adopted as a first step before we move on to a sham controlled trial. | |
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. | |
- Participants in the waitlist will not receive acupuncture treatment after randomization for 4 weeks, during which period, there will be six telephone visits. After this waiting period, they then will receive twice weekly acupuncture sessions for 4 weeks in the same manner as in the acupuncture group. |