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Table 1 Acupuncture treatment details based on the STRICTA 2015 checklist

From: Multimodal brain imaging effect of “Adjust Zang-fu and Arouse Spirit” electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial

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

  1. Abbreviation: STRICTA, Standards for Reporting Interventions in Clinical Trials of Acupuncture