Item | Item number | Detail |
---|---|---|
1.Acupuncture rationale | 1a) Style of acupuncture | Traditional Chinese Medicine |
1b) Reasoning for treatment | The treatment protocol was based on traditional acupuncture theory, previous studies guidelines, and the consensus of acupuncturists from the third Affiliated Hospital of Changchun University of Chinese Medicine | |
1c) Extent to which treatment was varied | All participants will receive standardized treatment. | |
2. Details of needling | 2a) Number of needle insertions per subject per session | 16 |
2b) Names of points used | Nine fixed points: GV20, GV24, BL13, BL20, BL23, ST36, SP6, LI4, LR3 | |
2c) Depth of insertion, based on a specified unit of measurement | From 0.5 to 1.5 cun | |
2d) Response sought (e.g., de qi or muscle twitch response) | De qi sensation | |
2e) Needle stimulation (e.g., manual, electrical) | Electrical stimulation: the electric stimulators (SDZ-V electroacupuncture apparatus, Suzhou Medical Appliance Factory, China) will be attached to needles at the GV20-GV24, unilateral BL13-BL23 and SP6-LR3 points, and a continuous wave of 2 Hz/100 Hz frequency, and an intensity of 0.1–1.0 mA will be applied | |
2f) Needle retention time | 30 min | |
2g) Needle type | Sterile disposable stainless steel needles of various lengths and diameters (Hwato Brand, Suzhou Medical Appliance Factory, China; 0.3 mm × 25 mm/0.3 mm × 40 mm) | |
3. Treatment regimen | 3a) Number of treatment sessions | 40 treatment sessions in both acupuncture and sham acupuncture groups |
3b) Frequency and duration of treatment sessions | Five times a week, followed by a 2-day rest interval, for 8 successive weeks | |
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 were allowed. Light diet and do not eat beef, lamb, seafood, mushrooms, and so on |
4b) Setting and context of treatment, including instructions to practitioners and information and explanations to patients | The study will be conducted at the acupuncture and massage center of the third Affiliated Hospital of Changchun University of Chinese Medicine. All patients will be admitted to the acupuncture therapeutic room for treatment. All information except patient allocated group will be provided to participants | |
5.Practitioner background | 5) Description of participating acupuncturists | Acupuncturists who are registered Chinese Medicine Practitioners in China and have at least 3 years’ clinical experience in acupuncture practice. Besides, they went through training classes before this trial and simulation to ensure that they are able to provide identical acupuncture treatment in accordance with a pre-defined protocol |
6. Control interventions | 6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice | Based on traditional acupuncture theory, previous studies, and the consensus of acupuncturists from the third Affiliated Hospital of Changchun University of Chinese Medicine |
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 | For the Sham-electroacupuncture group: participants will receive superficial non-acupoint sham- electroacupuncture 40 sessions over 8 weeks. Non-acupoints will be needled through adhesive pads to the skin (for the fixation of needles) without penetrating the skin using 1 cun blunt needles. The needle parameters and treatment regimen are the same as for the electroacupuncture group. When turned on, electric acupuncture apparatus looks normal but has no current output |