Item 1a: Style of acupuncture (e.g. Traditional Chinese Medicine, Japanese, Korean, Western medical, Five Element, ear acupuncture, etc)
Acupuncture has a long history in many cultures and is characterised by a broad diversity of styles and approaches in both East Asia and the West.(1) In order for the readers to contextualize the trial within the range of current clinical practices, researchers should state the overall style or approach on which they have based the treatments. If the researcher believes the treatment approach is completely novel, then this should be clearly stated.
i) We based the acupuncture point selections on Traditional Chinese Medicine meridian theory to treat knee joint pain, known as the “Bi” syndrome.(2)
ii) Participants were randomised to two styles of acupuncture: Japanese style (Kiiko-Matsumoto’s Form) and Traditional Chinese Medicine style.(3)
iii) Four out of five of the acupuncturists primarily practised the Five Element style with a diagnostic focus on individual ‘Causative Factors’,(ref) and one used the Traditional Chinese Medicine (TCM) style with diagnosis primarily based on syndrome patterns.(ref) Both styles are rooted in traditional acupuncture theory, and they are the most common traditional approaches used by professional acupuncturists in the UK today(ref).(4)
iv) Each patient was treated with non-local needle acupuncture (according to the theory of channels of Traditional Chinese Medicine) at distant points, and dry needling of local myofascial trigger points.(5)
Item 1b: Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate.
The author(s) should provide the reasoning for the chosen treatment, including rationale for diagnosis, point selection and treatment procedures. The “rules” that were used in providing treatments should be described. When treatments were selected that have roots in traditional practice, it is recommended that the historical and cultural context be supplied. This is relevant for interventions within styles such as “Traditional Chinese Medicine” or “TCM”, where the broad diversity of approaches requires careful identification of where and when the treatment parameters were developed. Where consensus methods, expert clinical panels, practitioner surveys or some combination of sources have been used to define the treatment protocol, it is recommended that full details of the methodology be given. Literature and other sources should be provided where relevant, in order that others can replicate the trial by consulting these source(s) and/or developmental methods on which treatment was based. Authors are encouraged to reference published works that are easily obtainable, such as a book or journal article. If the reference is a thesis, non-published work, written material only available in a different language from the journal article, or a verbal communication, authors are encouraged to present or summarise the information in an appendix or make it otherwise generally available (e.g. on a website). For fully individualised trials where the goal is to have representative practitioners who are encouraged to practice as they normally do, it is appropriate to specify the selection process for the practitioners, providing details of criteria for their inclusion. It is important to note that where details of the intended intervention are defined in advance, it is possible that what was actually administered may have differed. In such cases, precise details of the treatments that were provided are also necessary.
i) This study employed a style of Japanese acupuncture developed by Shima and Chace and Manaka et al , and follows the Japanese acupuncture training curriculum at the New England School of Acupuncture. In comparison to typical traditional Chinese medicine (TCM) acupuncture, Japanese acupuncture uses smaller needles and inserts needles less deeply and with less manipulation. For these reasons, we believed Japanese acupuncture would be less invasive than TCM, and thus better received by our adolescent population. Japanese acupuncture has bee shown to be effective in treating certain pain conditions.The specific acupuncture protocols employed in this study are briefly described below and discussed in greater detail in a companion paper.
(ii) We based point selection on individualized Western acupuncture techniques by using a list of points previously reported as being effective in neck pain and by reaching a consensus according to our own clinical and teaching practice. The specific points for each individual were defined at each treatment session, depending on the patient’s pain distribution and palpation of the neck and thorax to determine ah-shi points, or local tender points, for acupuncture. At least one distal point was used. Point location and depth of insertion were as described in traditional texts.
(iii) We developed the treatment strategies for acupuncture and minimal acupuncture in a consensus process with three acupuncture specialists (names provided) representing two major German societies for medical acupuncture: the German Medical Acupuncture Association (Deutsche A ¨ rztegesellschaft fu¨r Akupunktur, DA¨ GfA) and the International Society for Chinese Medicine (Societas Medicinae Sinensis, SMS). The first step involved three specialists (names provided) and the study team developing a proposal, which was followed by a discussion including more than 30 acupuncture experts from both acupuncture societies. The final intervention strategies were defined by the above mentioned three specialists together with the study team and subsequently were communicated to the external advisors .
Item 1c: Extent to which treatment was varied
The extent to which the treatment was individualised, both between patients and between practitioners, should be described. Trial protocols choose one of three broad levels of individualisation, ranging from none at all (all patients receiving the same treatment at all sessions), through partially individualised treatments (e.g. use of a fixed set of points to be combined with a set of points to be used flexibly), to fully individualised treatment protocols within which each patient receives a unique and evolving diagnosis and treatment. Additionally, the practitioners may have to apply a standardised theoretical framework, or may be allowed to apply their own. Many styles of acupuncture, whether based on traditional theories or Westernized concepts such as trigger points, are individualised in routine practice. Trials that are more pragmatic in their aim, and designed to replicate routine settings and patient groups, have more of an emphasis on fully individualised treatment. In such cases standardisation may consist of a protocol that instructs practitioners to provide treatments as they normally do. Trials that are more explanatory (mechanistic) in their aim tend to need a tighter definition of specific components in order to minimise variation across treatments.
i) Each patient received individualized acupuncture treatments that focused on specific needs and symptoms that the individual was experiencing. The rationale for this intervention was to test acupuncture as it is typically performed in practice. Point selection was based on the general principles of acupuncture and Traditional Chinese Medicine. The treatment was modified over the course of the study to accommodate the individual’s changing pattern of pain, sleep, or other health issues.
ii) The verum points consisted of obligatory points and additional points individually chosen by the physicians on the basis of traditional Chinese medicine diagnosis for syndromes (including tongue diagnosis), acupuncture channels related to the individual headache area, and Ah Shi points (locus dolendi points).
iii) The acupuncture protocol was based on the concept of adequacy of treatment,(ref) survey results,(ref) a consensus workshop, and recommendations from traditional Chinese protocols. We did not allow moxibustion, cupping, herbs, or electroacupuncture. For each individualised treatment session between six and 10 acupuncture points from 16 commonly used local and distal points were selected. Local points were Sp 9, Sp 10, St 34, St 35, St 36, Xiyan, Gb 34, and trigger points. Distal points were LI 4, TH5, Sp 6, Liv 3, St 44, Ki 3, BI 60, and Gb 41.
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]