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Item | Detail | Description of item |
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(1) Acupuncture rationale | (1a) Style of acupuncture (e.g., Traditional Chinese medicine, Japanese, Korean, Western medical, Five Element, ear acupuncture, etc.) | Traditional Chinese medicine |
(1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate | Consensus by all four recruiting centres following positive outcomes from the analysis of data collected from a pilot study |
(1c) Extent to which treatment was varied | Not varied except manipulation time shortened when patient by patient |
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(2) Details of needling | (2a) Number of needle insertions per subject per session (mean and range where relevant) | Two filiform needle insertions per subject used per session |
(2b) Names (or location if no standard name) of points used (uni/bilateral) | Large Intestine 11 (Quchi), unilateral Large Intestine 10 (Shousanli) unilaterally |
(2c) Depth of insertion, based on a specified unit of measurement or on a particular tissue level | Needling up to 1.5 body units (cun) |
(2d) Response sought (e.g., de qi or muscle twitch response) | Deqi measured after intervention sessions 1 and 9 using MASS |
(2e) Needle stimulation (e.g., manual, electrical) | Manual needle stimulation standardised: Wagging the Dragon’s Tail |
(2f) Needle retention time | Needles retained 28 minutes |
(2g) Needle type (diameter, length, and manufacturer or material) | Single use, presterile, filiform needles 0.30 mm × 40 mm Hua Tuo brand needles (Suzhou Needle Company) |
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(3) Treatment regimen | (3a) Number of treatment sessions | Nine sessions |
(3b) Frequency and duration of treatment sessions | Three treatments per week |
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(4) Other components of treatment | (4a) Details of other interventions administered to the acupuncture group (e.g., moxibustion, cupping, herbs, exercises, and lifestyle advice) | No additional interventions administered Medication use logged in diary if used |
(4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | Four sites in China, Changchun University of Chinese Medicine hospital clinic; Hong Kong, Hong Kong Baptist University clinic; Italy (Center on Nonconventional Medicine clinic); and Australia (UTS TCM Clinic) |
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(5) Practitioner background | (5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) | All practitioners had at least seven years of clinical experience and were members of the World Federation of Acupuncture-Moxibustion Societies (WFAS). |
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(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 | Noninvasive inactive sham laser which does not pierce the skin See [9] for justification |
(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. | Inactive sham laser therapy to the same local acupuncture points as the treatment group using a modified inactive laser unit |
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