Item | Detail | |
---|---|---|
1. Acupuncture rationale | 1a) Style of acupuncture | Electroacupuncture based on traditional Chinese medicine |
1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate | Based on consensus of the PDPN, meridian and acupoint theory, clinical articles and experience, experimental articles, traditional acupuncture | |
1c) Extent to which treatment was varied | Volunteers will receive traditional standardized treatment | |
2. Details of needling | 2a) Number of needle insertions per subject per session (mean and range where relevant) | 14 |
2b) Names (or location if no standard name) of points used (uni/bilateral) | Bilateral BL13, BL20, BL23, LI4, ST36, SP6, LR3 | |
2c) Depth of insertion, based on a specified unit of measurement, or on a particular tissue level | 1.0 ± 0.5 cm | |
2d) Response sought (e.g. de qi or muscle twitch response) | De qi | |
2e) Needle stimulation (e.g. manual, electrical) | Electrical density wave with a frequency of 2 Hz/100 Hz and the current intensity is in the range of 0.1~1.0 mA (Hwatuo, Suzhou, China) | |
2f) Needle retention time | 30 min | |
2 g) Needle type (diameter, length, and manufacturer or material) | A sterilised stainless steel needle (length 25–40 mm, diameter 0.25 mm; Hwatuo, Suzhou, China) | |
3. Treatment regimen | 3a) Number of treatment sessions | 4 sessions |
3b) Frequency and duration of treatment sessions | 1 sessions per day for 6 day | |
4. Other components of treatment | 4a) Details of other interventions administered to the acupuncture group (e.g. moxibustion, cupping, herbs, exercises, lifestyle advice) | Treat with conventional western medicine, drugs to control blood glucose, nourish nerves and analgesia |
4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | The study will be carried out in the Affiliated Hospital of Changchun University of traditional Chinese medicine. All patients will send to the outpatient of acupuncture. Participants will be provided all information except patient allocated group | |
5. Practitioner background | 5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) | A doctor who has a licence with at least 2 years of clinical practice. They can skillfully use acupuncture. All participants received standardized training to ensure consistent treatment |
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 | Based on consensus of the PDPN, meridian and acupoint theory, clinical articles and experience, experimental articles, traditional 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 1–3 above. | For sham electroacupuncture group, besides BL13, BL23 and SP6, LR3 will be stimulated 30 min per day for 6 days using blunt needles that cannot penetrate the skin. Electrical stimulation will perform with the power cord cut off |