Table 3.
Item | Item criteria | Description |
---|---|---|
(1) Acupuncture rationale | (1a) Style of acupuncture | Traditional Chinese medicine therapy |
(1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate | (i) Reasoning for treatment provided—based on historical context, literature sources, and traditional Chinese medicine (consensus) (ii) Reasoning for treatment provided—based on historical context, literature [27,28], selection of treatment regions based on related papers, expert experience, and textbooks |
|
(1c) Extent to which treatment varied | Standardized treatment | |
(2) Details of needling | (2a) Number of needle insertions per subject per session (mean and range where relevant) | 10 or 12 |
(2b) Names (or location if no standard name) of points used (unilateral/bilateral) | DU20 (Baihui), EX-HN1 (Sishencong), HT5 (Tongli), GB39 (Xuanzhong), EX-HN12 (Jinjin), EX-HN13 (Yuye), CV23 (Lianquan) | |
(2c) Depth of insertion, based on a specified unit of measurement or a particular tissue level | Needle insertion will follow an angle of 90°in an inferomedial direction for the two points (HT5, GB39). Depth: 0.5 cun [≈10 mm]. Needle insertion followed an angle of 15° in an inferomedial direction for the two points (DU20, EX-HN1). Depth: 0.5 cun. For RN23, the angle is 90° and the depth is 1 cun [≈20 mm]. EX-HN12 and EX-HN13 were quickly inserted for bloodletting | |
(2d) Responses sought | Following needle insertion, small, equal manipulations of twirling and thrusting will be performed on all needles to reach de qi | |
(2e) Needle stimulation | Small, equal manipulations of twirling and thrusting will be performed on the needles of HT5 and GB39 | |
(2f) Needle retention time | 30 min per session | |
(2g) Needle type | Sterile, stainless, disposable acupuncture needles (size 0.25 mm × 40 mm, product no. 20182270011; ANDE Acupuncture, Guizhou ANDE Medical Equipment, China) | |
(3) Treatment regimen | (3a) Number of treatment sessions | 12 |
(3b) Frequency and duration of treatment sessions | 3 times/week, 30 min per session, on alternate days, for 4 successive weeks | |
(4) Other components of treatment | (4a) Details of other interventions administered to the acupuncture group | None |
(4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | The study will be conducted in the Dongzhimen Hospital affiliated to BUCM, China Rehabilitation Research Center, and Peking University Third Hospital, and all information will be provided to the subjects | |
(5) Practitioner background | (5a) Description of participating acupuncturists | The chief physician of Dongzhimen Hospital, Ph.D., 11 years of formal university training in traditional Chinese medicine, with qualifications for practising doctors stipulated in the law |
(6) Control or comparator interventions | (6a) rationale for the control or comparator in the context of the research question, with sources that justify the choice | The nonacupoint control group will receive sham acupuncture with real acupuncture needles at nonacupoint locations. Through such an approach, the self-perception of placebo effects in the nonacupoint control group is difficult to distinguish from the real acupoints |
(6b) Precise description of the control or comparator; details for items 1–3 with the use of sham acupuncture or any other type of acupuncture-like control | Participants in the nonacupoint control group received sham acupuncture with a pragmatic placebo needle on a sham acupoint. The needles used are the same as the acupoint group. Procedures and other treatment settings will be the same as in the acupoint group but with no needle manipulation for de qi |