The
treatment with sham acupuncture
was standardised too. To trigger only a minimal unspecific
physiological
stimulus, sham acupuncture is applied with a minimal depth of needling
(not
exceeding 5 mm), avoiding real acupoints. A manual stimulation of needles is
not allowed.
General
procedure, anamnesis, diagnostics and communication with patients must be
performed
exactly as in the verum acupuncture group.
As
sham-points ten points in total are chosen, four on each leg and one on each
arm. In localising
the points,
the Chinese measure cun is applied: 1 cun corresponds to the width of a
patient's
thumb.
• One
point between the gall bladder- and stomach-meridian on the distal part of the
fibula,
2 cun above
the Malleolus lateralis, in the direction towards the knee.
• At
each case, one point 2 cun and 6 cun above the Malleolus medialis in the center
of the
tibia
surface area intracutaneous without periost contact, in the direction towards
the knee.
• One
point in the centre of the thigh on the connecting line from the centre of the
patella to
spina iliaca
anterior superior, in the direction towards the hip.
• One
point on the highest spot of the tightened musculus biceps brachii.
Patients
randomised to one of the two acupuncture arms get 10 acupuncture treatments
within
the first
six weeks with a duration of needling of 20-30 minutes. Patients in the
conservative
standard
therapy arm should have also 10 visits to try to have the same devotion.
Patients
graded as
"partially successfully treated" during the interview in week 7 are
allowed to receive
five
additional visits/treatments. The criteria is based on a global pain score and
not
known to the
investigator.
page 6 of 1616
All patients
treated with acupuncture or sham acupuncture are allowed during the first two
weeks of
treatment to take Diclofenac (up to 150 mg/day) or Rofecoxib (up to 25 mg/day).
During the
third treatment week until the end of week 23 of the trial the patient is allowed
to
use a total
dose of 1.000 mg Diclofenac (max. dose 150 mg/day) or a total dose of 175 mg
Rofecoxib
(max. dose 25 mg/day). During the last three study weeks before measurement of
the primary
endpoints of the study no further pain medication is allowed. In case of
emergency
the use of
up to 150 mg/day Diclofenac is allowed during the whole duration of the
trial, but
has to be counted as treatment failure. (aus: "http://www.biomedcentral.com/1472-6882/4/6" )