Item 2a: Number of needle insertions per subject per session (mean and range where relevant).
It is recommended that the reporting of this itemshould include a total of needle insertions per subject per session. This item is relevant to all designs of randomised controlled trials, from pragmatic to explanatory. For more explanatory designs where a formula of points is prescribed, the number of needle insertions should be reported as a simple total. For more pragmatic designs, with individualised treatments, the mean and range should be reported. Clearly, full details of individualised treatment cannot be reported in every section of Item 2 below. However, each item should be considered and as much information given as possible.
(i) The protocol allowed for up to 10 treatments per patient, the precise number being agreed between patient and practitioner. A total of 1269 treatments were provided, an average of 8.6 treatments per patient (range 1–10) and 9.6 needles per treatment (range 6–12). See (table) for variations between practitioners.
(ii) Disposable stainless steel needles (0.2650mm, Seirin) were inserted into the skin over the trigger point to a depth of 10–30mm, appropriate to the muscle targeted, attempting to elicit a local muscle response using the ‘‘sparrow pecking’’ technique. After the local twitch response was elicited or a reasonable attempt made, the needle was retained for a further ten minutes. The mean number of insertions was 3.3.
(iii) In the real acupuncture group, the acupuncture points Hegu (LI 4), Jiache (St 6), Xiaguan (St 7) and Yifeng (SJ 17) were used unilaterally on the tooth extraction side.
Item 2b: Names (or location if no standard name) of points used (uni/bilateral).
The point descriptions in the seminal classic texts, such as the Huangdi Neijing (Inner Canon of the Yellow Emperor) are rare and vague. The depiction of acupuncture points in relation to precise anatomical structures dates back only 100 years. Since the mid 1950s a process of standardisation has been taking place, and the acupuncture point descriptions based on anatomical locations and proportional cun measurement systems have served as a blueprint for many Western translations. It should be noted that these locations have not been universally adopted.
Given this historical context, it remains important to know which acupuncture points have been used in clinical trials, with as accurate descriptions as possible of the location of these points, and where relevant the method used to identify the points.
The specific point locations used in treatments where standardised should be described in terms of an accepted nomenclature (e.g. GB21) or in terms of anatomical location where there is no accepted name. Whether the needles are inserted unilaterally or bilaterally should be stated. For protocols with partially individualised prescriptions, list any prescribed essential or optional points, and describe (in the Results section) both the points used at every visit, and all the points used on an ad hoc basis. If the list is extensive, the most commonly used points (with percentages) should be reported. Where protocols specify using fully individualised point prescriptions, authors should consider the best way to report the points used, for example by listing all points across all subjects, or by identifying the most commonly used points if the list is extensive.
(i) We based the acupuncture point selections on Traditional Chinese Medicine meridian theory to treat knee joint pain, known as the ‘‘Bi’’ syndrome. These points consisted of 5 local points (Yanglinquan [gall bladder meridian point 34], Yinlinquan [spleen meridian point 9], Zhusanli [stomach meridian point 36], Dubi [stomach meridian point 35], and extra point Xiyan) and 4 distal points (Kunlun [urinary– bladder, meridian point 60], Xuanzhong [gall bladder meridian point 39], Sanyinjiao [spleen meridian point 6], and Taixi [kidney meridian point 3]) on meridians that traverse the area of pain. The same points were treated for each affected leg. If both knees were affected, 9 needles were inserted in each leg.
(ii) The VA (verum acupuncture) group received acupuncture with a 0.25640-mm stainless steel needle (Asia Med, Munich, Germany) at LI4, which is situated between the first two metacarpal bones on the dorsal side of both hands at the top of the muscle belly (figure provided).
(iii) The most frequently treated local points were Bl 23, Bl 25, Gb 30, DU 4, Bl 26, and the extra point Huatuojiaji (table provided) ..….. The most frequently treated distant points were Bl 40, Kid 3, Gb 34, Bl 60, SI 3, and DU 20. In most cases, 8 to 12 local points and 4 to 6 distant points were used. Physicians used additional acupuncture points in 565 of the treatment sessions. The most frequently used additional local points were Li 4, St 40, Bl 17, Sp 6, and St 36.
Item 2c: Depth of insertion, based on a specified unit of measurement, or on a particular tissue level.
The depth of insertion should be expressed using the Chinese measurement of the cun; in terms of anatomical depth, for example, of subcutaneous tissue, fascia, muscle or periosteum; or in millimetres. For some trials, the protocol might specify the angle and direction of insertion along with depth of insertion, in which case these should also be reported.
(i) All needle placements were performed by an experienced acupuncturist at a premarked depth of 4 mm from the tip of the needle.
(ii) The depth of needle insertion varied with thickness of the skin and subcutaneous fatty tissues at the site of the acupuncture points; it was usually 1 to 1.5cm.
(iii) Shallow and light needling stimulation (1–2 mm) using fine needles (0.18–0.16 mm) inserted with the aid of insertion tubes was emphasized. Points were needled at a 10u–20u angle with a 2-hand needling technique, generally in the direction of the flow of the channel.
Item 2d: Responses sought (e.g., de qi or muscle twitch response).
If the study protocol requires that specific responses to needling be elicited, for example the de qi sensation in traditional Chinese acupuncture, the muscle twitch in trigger point treatment or muscle contraction in electro-acupuncture, these elicited responses should be reported. Where relevant, the authors should differentiate between the responses required in the protocol and those actually obtained (which should be reported in the Results section).
(i) The TRP (trigger point) group received treatment at trigger points. The correct application of the technique requires experience in palpation and localisation of taut muscle bands and myofascial trigger points. Precise needling of myofascial trigger points provokes a brief contraction of the muscle fibres. This local twitch response must be elicited for successful therapy but it may be painful and post treatment soreness is frequent.
(ii) In contrast with TCM style acupuncture, we did not employ vigorous manipulation in order to elicit a strong de qi sensation (defined as a feeling of heaviness around the acupuncture point). Practitioners focused instead on feeling the response to stimulation as an ‘‘echo’’ sensation experienced on the receiving hand, while the active hand performed the actual needling. Attention was placed on reactivity or change in diagnostic areas, especially the pulse and abdomen. By carefully assessing changes in palpatory findings, the treatment was adjusted continuously based on the patient’s response. Before needling, the ‘‘live’’ points were identified by palpation, that is, subtle changes at the skin level, or upon touch or pressure, for that particular patient.
Item 2e: Needle stimulation (e.g. manual or electrical).
Needle stimulation techniques, where used, should be clearly described for all points. For manual stimulation, such techniques include lifting, thrusting or rotating the needle to manipulate the de qi sensation. For electrical stimulation, the current, amplitude and frequency settings should be recorded.
(i) This mode of (manual) stimulation was provided via the acupuncture needles, which were placed in the premarked depth at the marked sites. The needle was rotated by an experienced acupuncturist with the index finger and thumb in an alternating clockwise and counterclockwise fashion at the rate of three to five rotations per second.
(ii) Electrical stimulation was given to the anterior part of the knee for 10 minutes and then 10 minutes for the posterior part using a battery-operated, four-channel, ‘AS Super 4’ Electrostimulator (RDG Medical, Surrey UK) which generated low frequency, square-wave (2–10Hz) pulses of 1 millisecond duration for 10 minutes. In both groups, the apparatus was attached to needles at the two Xiyan points, SP9 and GB34, and BL40 and BL57. Electrical stimulation was delivered at 6Hz at a constant current. Voltage was set at a level just above the pain threshold.
Item 2f: Needle retention time
Needle retention times should be reported as either a standard or a mean and range. Authors should make it clear that they are reporting the time elapsed between the insertion and removal of needles (retention time) and distinguish it from treatment time, which may include other procedures such as history taking, discussion and preparation for treatment.
(i) Each participant was treated bilaterally and had a total of six needles inserted for the duration of the treatment. A draining technique was used and the needles were left for a period of 30 minutes. The practitioner returned to check on the participant at regular intervals during the intervention.
(ii) Needles were withdrawn immediately for tonification, and retained for up to 20 minutes for the evens technique.
(iii) Therapists allow 25 (min) to 35 (max) minutes between insertion of the last needle and cessation of treatment and during that time they are to revisit the needles as appropriate.
(iv) The patients in group A were dry-needled for a few seconds. For trigger point inactivation by dry needling… it is especially important not to apply too strong a stimulus because this may produce a flare-up of the patient’s symptoms.
Item 2g: Needle type (diameter, length, and manufacturer or material)
Details should be given of the types of needles used, including the diameter and length as well as the manufacturer and/or the material. This information is of importance since the effect of different metals or needle sizes on the body is not known. For trials using a variety of different types of needles, the ranges of diameters and lengths as well as types of material should be reported.
(i) Seirin 36 gauge 2.5 inches long unused sterile L-type needles were used for the study.
(ii) The VA (verum acupuncture) group received acupuncture with a 0.25640-mm stainless steel needle (Asia Med, Munich, Germany) at LI4.
For a fully-referenced version of these explanations and examples for this item, please refer to the following paper:
MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement. PLoS Medicine 2010; 7(6): e1000261. doi:10.1371/journal.pmed.1000261. [full text]