Acupuncture as an Adjunctive Therapy to the Pharmacological Treatment in Patients With Chronic Pain in Osteoarthritis of the Knee: a Three Armed Randomized Placebo Controlled Trial

The participants were recruited randomly from the outpatient population at the Orthopaedic Clinic of the General Hospital of Florina from September1, 2007 until February 15, 2008. The study was approved by the Scientific committee and the Ethics and Deontology committee of the Athens University Hospital "Aretaieion" and the General Hospital of Florina "Eleni Dimitriou". Of 259 patients diagnosed with osteoarthritis of the knee, 55 chose not to participate and from the remaining 201 patients, only 120 me the participation criteria and were included in the study.

To be eligible for the study, patients must have met the American College of Rheumatology criteria for diagnosis of knee osteoarthritis. Patients must also have had a Kellgren-Lawrence (radiologic criterion) score of at least 2 and chronic pain in the knee joint for longer than 3 months. After being fully informed of the study's aims, all participants provided written consent abiding with the declaration of Helsinki. Ineligible patients included those who had received intra-articular corticosteroid or hyaluronate injection during the last 3 months, corticosteroids, antiplatelet drugs (apart from acetylsalicylic acid 100mg), or immunosuppressive drugs. Patients who were pregnant, or who had suffered from a malignancy of any kind, psychiatric disease, stroke, heart attack, kidney failure, active gastric or duodenal ulcer, or gastrorrhagia were also excluded. Finally patients who had previous treatment with acupuncture, other forms of arthritis, or who had arthroplasty during the last year were also ineligible for the study.

After screening, patients meeting the participation criteria were asked for informed consent, and were randomly assigned to 3 different groups: Group I was assigned to treatment with etoricoxib alone, Group II was assigned to treatment with acupuncture and etoricoxib, and Group III was assigned to treatment with sham acupuncture and etoricoxib. Baseline Western Ontario and McMaster Universities Osteoarthritis (WOMAC) values, Visual Analogue Scale (VAS) and SF-36v2 health survey (for quality of life) parameters were recorded. Baseline body mass index (BMI), complete blood count (CBC), C-reactive protein levels, erythrocyte sedimentation rate (ESR), Rheumatoid (Rh) Factor type, kidney and liver function tests, uric acid levels, and arterial blood pressure were recorded and followed throughout the study. Finally, a unique tender point around the knee, was found for each patient and was marked and photographed. A Pain Test™ FDK 20 Algometer was used to score the pain throughout the study using this predetermined tender point. During follow-up, the doctor performing the acupuncture was the only one who was aware of the group each patient belonged to. This physician did not perform randomization or any patient evaluations or statistical analysis.

Randomization Eligible patients were randomly allocated to 3 treatment groups. In order to ensure similar treatment numbers, blocked randomization was used. Blocks of 3 patients were allocated to the 3 treatment groups and a random, computer generated sequence was assigned to each block.

Interventions