BACKGROUND: The pain and the unstability of the knee joint are the main clinical manifestation of knee osteoarthritis. OBJECTIVE: To verify the efficacy of ultrasonic drug penetration combined with quadriceps exercise in treating senile knee osteoarthritis. DESIGN: Randomized controlled study. SETTING: Rehabilitation Department of the Affiliated Hospital of Luzhou Medical College. PARTICIPANTS: Seventy-six in-patient and out-patient cases of the knee osteoarthritis, 28 males and 48 females and total 109 knees, were chosen in the Orthopaedic Department and Rehabilitation Department in the Affiliated Hospital of Luzhou Medical College in the period between August 2001 and August 2004. The cases were randomly divided into the experimental group and the control group with 38 cases each. INTERVENTIONS: (1) The experimental group: The CZ-01 ultrasonic therapy apparatus made in Mianyang was adopted and the diameter of the handpiece was 3 cm. 10 g/L dichloride sodium emulsion (made by Beijing Nuohua Pharmaceutical Co Ltd) was taken as the coupling agent to smear around the knee joint about 0.75 to 1.25 W/cm2, once a day, and 8 to 10 minutes per time. Meanwhile the static isometric contraction exercise of the knee joint in the extension position was done. Using the quardriceps isometric exercise apparatus, the Delorme progressive resistance exercise was performed once or twice a day. (2) The control group: the same ultrasonic therapy was done as the therapy group. The nonthermal and microthermal ultrasonic wave was adopted on the suffered location 10 to 15 minutes per time, and the tolerance dose of the mid-frequency current was given 20 minutes per time and once a day using the CM-518B computer mid-frequency current therapy apparatus. (3) The therapy efficacy was assessed in the two groups 4 weeks after the therapy. During the therapy period the anti-inflammatory and analgesic drugs were not used. (4) The visual comparison scale was used in the evaluation of the patient's knee joint activities of daily life (0 score signifies no pain, 10 scores severe pain, the pain relief better than 40% that before the therapy means the effectiveness). The lower limb activity of daily life was chosen to evaluate the patient's knee joint activities of daily life (5 items, total 10 scores, high score means good, low score means poor). The maximal loading dose in the extension position of the knee joint was measured on the quadriceps isometric exercise apparatus using the suspension weight method. MAIN OUTCOME MEASURES: (1) The evaluation of the numerical pain scale in the two groups before and after the therapy. (2) The evaluation of the patient's knee joint activities of daily life in the two groups. (3) The maximal loading dose in the extension position of the knee joint in the two groups. RESULTS: The data of 76 cases all went into the result analysis. (1) The result of the walking pain scale in the two groups before and after the therapy: The score of pain evaluation after therapy was significantly lower than that before the therapy (p < 0.01), and there was no significant difference between the two groups (p > 0.05). (2) The comparison of the patient's knee joint activities of daily life in the two groups before and after the therapy: the result after the therapy was significantly better than that before the therapy, and the efficacy after the therapy was significantly higher than that before the therapy, the efficacy of the experiment group was better than that of the control group (9.61 +/- 1.82, 8.77 +/- 2.28), while there was no significant difference between the two groups (p > 0:05).3The evaluation results of the maximal loading dose in the extension position of the knee joint in the two groups: the result of the experimental group after the therapy was significantly better than that of the experimental group before the therapy and the control group (10.05 +/- 2.41 kg versus 7.86 +/- 1.98 kg and 8.76 +/- 1.65 kg, p < 0.01). CONCLUSION: The ultrasonic wave using the dichloride sodium emulsion as the ultrasonic coupling agent in combination with quadriceps strengthening exercise in treating the senile knee osteoarthritis is efficacious in relieving pain and improving the ADL ability of the knee joint, increasing the maximal loading dose in the extension position of the knee joint and the stability of the knee joint. The efficacy of the combination therapy is better than the single ultrasonic therapy.

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