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
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The objective of this study is to assess the efficacy of acupuncture as an adjunctive therapy
      to pharmacological treatment of chronic pain due to knee osteoarthritis, as well as for, the
      improvement of physical functioning, reduction of stiffness, and improvement in quality of
      life. This is a 3-armed single-blinded randomized sham-controlled trial, comparing
      acupuncture along with pharmacological treatment, sham acupuncture including pharmacological
      treatment, and pharmacological treatment alone. One-hundred and twenty patients with knee
      osteoarthritis were randomly allocated to 3 groups. Group I was treated with etoricoxib,
      Group II was treated with acupuncture and etoricoxib, and Group III was treated with sham
      acupuncture and etoricoxib.
    

Detailed description: 
      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

      Group I (Pharmacological) All patients received 60-mg etoricoxib tablets once-daily for 60
      days.

      Groups II and III (Acupuncture) A doctor specializing in acupuncture (accredited by the
      International Council of Medical Acupuncture and Related Techniques [ICMART] and the Medical
      Acupuncture Society of Northern Greece) selected the acupuncture points that would be
      effective for osteoarthritis of the knee according to traditional treatment methods.

      The protocol for acupuncture was to insert single use, sterile, 30 mm long and 30 gauge
      acupuncture needles into the local points ST36, SP9, SP10, GB34, Ex-LE 2, and Ex-LE5 as well
      as the distal points Li4, Ki3, ST40, and SP6. At each point, the patient confirmed the De Qi
      sensation (a feeling that indicates effective needling). This treatment was given biweekly
      for 8 weeks. Starting from the third session, the ES - 160 electrostimulator ITO co. (2-6Hz,
      150 ms for 20 minutes) was used to stimulate the needles in pairs ST36-SP9 and GB34-SP10.

      Sham acupuncture was administrated at the same duration and frequency by the same specialist
      who performed the non-sham acupuncture. Retractable needles were placed into small adhesive
      cylinders, so that the needles were supported but did not perforate the skin [30]. The
      acupuncturist placed the needles at the same points as the non-sham group and used the same
      pairs of electrodes to simulate the electrical connection.

      All patients were instructed to check their arterial blood pressure daily. Patients with risk
      factors for upper gastrointestinal (GI) tract complications received proton pump inhibitors
      (PPIs).

      All patients completed standard questionnaires at baseline, and after 4, 8 (final treatment
      week), and 12 weeks.

      An examination for possible side effects of both acupuncture and pharmacological treatment
      was performed at each visit. These side effects included gastrointestinal tract
      complications, blood pressure increases, and haematomas at the acupuncture point.

      The scale for the primary endpoint was the WOMAC index Version VA3.1 and its three subscales
      (pain, stiffness, and physical function) at the end of treatment, week 8. Additional outcome
      measures were the WOMAC scales at weeks 4 and 12, VAS (0-100) [26,12] at weeks 4, 8 and 12,
      and the Greek version of SF-36v2 Health Survey with its two components (physical-mental) for
      assessment, of health related quality of life at the end of week 8. The score from the direct
      measurement of pain at the predetermined unique trigger point was measured with the Pain
      Test™ FDK 20 Algometer of Warner USA at the end of weeks 4, 8, and 12. In cases of bilateral
      osteoarthritis of the knee, the most painful knee at baseline was assessed throughout the
      study.

      Statistical Analyses Descriptive statistics like the mean ± standard deviation (SD), median,
      minimum (min) and maximum (max) are used to present continuous variables. Categorical
      variables were analyzed using χ2 tests and are reported as frequencies or percentages.

      For multiple group comparisons, the one-way ANOVA test was used to determine statistically
      significant differences between groups of variables with data that were normal distributed,
      while the Kruskal Wallis test was used for groups with data that were not normally
      distributed. Post hoc tests were performed only for statistically significant group
      differences. Paired t-tests (or Wilcoxon tests when appropriate) were performed in order to
      assess differences between different time points in the same group. Data analysis was
      performed using the statistical package SPSS v 15.0
    

Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): This is a 3-armed single-blinded randomized sham-controlled trial, comparing acupuncture along with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acupuncture; knee osteoarthritis; adjunctive therapy; chronic pain; algometer; etoricoxib.