Research Article

Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy

Table 1

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) 2010 items and their description in the protocol for the treatment group.

Item Detail Description of item

(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 appropriateConsensus by all four recruiting centres following positive outcomes from the analysis of data collected from a pilot study
(1c) Extent to which treatment was variedNot varied except manipulation time shortened when patient by patient

(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 levelNeedling 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 timeNeedles 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)

(3) Treatment regimen(3a) Number of treatment sessionsNine sessions
(3b) Frequency and duration of treatment sessionsThree treatments per week

(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 patientsFour 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)

(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).

(6) Control or comparator interventions(6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choiceNoninvasive 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