plete the study questionnaire. Criteria for exclusion were
previous treatment with acupuncture; contraindication to medi-
cation with diclofenac; inflammatory, metabolic, or neuropathic
arthropathies; severe concomitant illnesses that might interfere
with the clinical evaluation of the patient; severe or generalised
dermopathy; pregnancy or existing treatment with antineoplasic,
corticoid, or immunosuppressive drugs.
The patients were divided into two groups, an intervention
group treated with acupuncture plus diclofenac and a control
group given placebo acupuncture plus diclofenac. We used a
computer program to assign the patients randomly to one or the
other group8
; the invention group comprised 48 participants
and the control group 49. We used a simple random allocation
method. We sent out sealed opaque envelopes. Only the doctor
applying the treatment was aware which group each patient had
been assigned to, and he did not participate in any phase of the
subsequent evaluation. We took precautions to maintain the
confidentiality of the data concerning the participating patients.
Before starting treatment, all patients observed a one week
period during which they did not take any NSAIDs.