Item 6a: Rationale for the control or comparator in the context of the research question, with sources that justify this choice
The rationale for choice of control or comparator should be presented and justified in relation to the research question and the methodology. In studies in which a group receiving acupuncture is compared with another group, the control or comparator can be sham acupuncture, usual care, an active treatment, a waiting list or no treatment. Whereas ‘control’ is sometimes used for a group that receives no intervention, the term ‘comparator’ may be more appropriate for an active intervention, such as physiotherapy, for which the intended action of the comparator is expected to be therapeutic.
If using an acupuncture-like control in a participant-blinded trial then one of the following terms: active acupuncture control; penetrating needle control; or non-penetrating sham needling control might be helpful descriptors. Control procedures involving invasive or non-invasive sham needling techniques may be therapeutically active, evoking neurophysiological and/or localised immune and circulatory responses. The extent that sham acupuncture needling, whether penetrating or not, might elicit acupuncture-specific physiological mechanisms is not known, and is in part a consequence of our lack of knowledge of the mechanism(s) of true acupuncture. There are also variations in assumptions about the precision required for point location, as for some clinicians and investigators, acupuncture points are considered as areas of reactivity rather than points of action. Such assumptions have a bearing on the integrity of the sham as an appropriate control. Some non-needling control procedures can be assumed to be physiologically inert, such as an inactivated transcutaneous electrical nerve stimulation (TENS) machine; however, these procedures may not have the same total psychophysiological credibility as acupuncture, thereby compromising the interpretation of the results.
Sources that led to the choice of control, such as literature or expert opinion, should also be reported and referenced. The author should reference prior work that supports the use of the selected comparator, such as from the conclusion of a systematic review or from another randomised controlled trial.
(i) ‘Sham’ acupuncture points were chosen from three different areas on the body (the anterior thigh distally, the posterior thigh, and the lateral aspect of the lower back), which do not correspond to recognized acupuncture points and are deemed to have no therapeutic value.
(ii) International guidelines suggest that the best package of care for this patient group is one that includes patient education, advice and exercise…. Randomised clinical trials consistently show the benefit of exercise for knee pain in older adults. Recent studies also highlight the need to provide adequate instruction, feedback and practice in order to ensure that the key muscle groups around the knee, such as the quadriceps, are activated. The European League Against Rheumatism (EULAR) recommendations have recently been updated and in particular, advocate exercise for knee pain related to osteoarthritis. In line with this evidence base, the current trial was designed so that all participants receive a package of care which includes education, advice, and exercise.
(iii) For this study a special ‘placebo needle’ was designed by Streitberger. The needle body is not fixed inside the copper handle. Its tip is blunt and when it touches the skin, a small pricking sensation is felt by the patient, simulating the puncture of the skin. The handle of the needle moves over the needle, the needle is shortened. Patients ‘see’ the needle moving inside their body… This needle was tested in 60 volunteers and proved to be sufficiently credible to be used in our clinical trial as a control.
Item 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.
A precise description of the components of the control or comparator should be presented. If the control treatment is an acupuncture-like intervention, such as a form of sham acupuncture, then it should be specified whether the sham is invasive (penetrating the skin) or non-invasive (non-penetrating). The theoretical basis, needling details and regimen of an acupuncture-like control need to be reported in the same way as is set out in STRICTA Items 1 to 3 above.
The lack of a world-wide consensus on the location and size of acupuncture points reinforces the importance of accurate documentation of the sham points actually used, their precise location and the method used to locate them.
If usual care or another active treatment is the comparator, all the components should be reported in full detail. This will enable readers to compare usual care as provided in the trial with what is usually provided to participants in another setting. Where usual care is also provided to those receiving acupuncture, these data will also allow readers to compare the intensity of usual care in the comparator arm with that of the experimental arm. If it is a waitlist arm, then the period of waiting needs to be specified. While precise description of the control or comparator is fairly straightforward in principle, the more complex the components, the more care is required to specify them precisely.
(i) Acupuncturists inserted 2 needles into the sham points in the abdominal area, approximately 3 cm lateral to and slightly above the umbilicus bilaterally, and then immediately applied 2 pieces of adhesive tape next to the needles. In addition, they tapped a mock plastic needle guiding tube on the surface of each of the 9 true points in the leg to produce some discernible sensation and then immediately applied a needle with a piece of adhesive tape to the dermal surface, without needle insertion, of each point for a total of 20 minutes. The sham acupuncture procedure was given on the same schedule as the experimental group and used the same active needle placements, except actual insertion did not occur at these 9 points. Although electrical stimulation did not occur, a mock transelectrical stimulation unit (which emitted a sound and possessed a blinking light) was attached to the sham needles at the knee. To facilitate blinding, we used screens in both treatment and sham groups that were placed below the abdomen to prevent participants from actually observing the true or sham procedures at the knee area but to allow them to observe the procedure being performed in the abdomen area.
(ii) In each session, at least 5 out of 10 predefined distant nonacupuncture points were needled bilaterally (at least 10 needles) and superficially using fine needles (ie, minimal acupuncture). ‘‘De Qi’’ and manual stimulation of the needles were avoided. All acupuncturists received oral instructions, a videotape, and a brochure with detailed information on sham acupuncture.
(iii) Conservative therapy involved 10 visits to practitioners with consultation and a prescription for diclofenac, up to 150 mg/d, or rofecoxib, 25 mg/d, as needed until week 23.
(iv) Patients received the same treatment as in the standard group but in addition did stabilising exercises modified because of the pregnancy. The training programme started by emphasising activation and control of local deep lumbopelvic muscles. Training of more superficial muscles in dynamic exercises to improve mobility, strength, and endurance capacity was gradually included. Patients received treatments individually for a total of six hours during six weeks. They were told to integrate the exercises in daily activities and to exercise in short sessions on several occasions during the day.
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]