Item
6a:
Rationale
for the control or comparator in the context of the research question,
with sources that justify the choice(s)
Examples:
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.
(1)
ii) International guidelines suggest that the best package of care for
this patient group is one that includes patient education, advice and
exercise (ref). …. Randomised clinical trials consistently show the
benefit of exercise for knee pain in older adults (refs). 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 (ref). The European League Against
Rheumatism (EULAR) recommendations have recently been updated and in
particular, advocate exercise for knee pain related to osteoarthritis
(ref). 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.
(2)
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(ref).
(3)
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.
Examples:
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
(4)
.
ii) In each session, at least 5 out of 10 predefined distant
nonacupuncture points (see Melchart et al for details) 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.
(5)
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.
(6)
iv) Patients received the same treatment as in the standard group
but in addition did stabilising exercises modified because of the
pregnancy.(refs) 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.
(7)
References:
