Knee Osteoarthritis
Conditions
Interventions
Patch group: external patch NSAIDs external patch were used on the tender spot around the knee joint 2 times (at morning, after bath or at night) per day. The external patch was kept at room temperat
flurbiprofen, indometacin, and ketoprofen.
Oral agent group: Oral NSAIDs NSAIDs were limited only one of the following three to prescribe. These were the top three used in Japan at the present
loxoprofen sodium, diclofenac sodium, and zaltoprofen. They were also required to record exactly how many they had been taking medicine in a note.
Sponsors
The Japanese Society for Musculoskeletal Rehabilitation
Japanese Clinical Orthopaedic Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient satisfying the following conditions (1)-(6) is included. (1) Outpatients with knee pain, age 50-80 years old. Both men and women are able to enter the trial. (2) New patients for medical institution concerned, who receiving no treatment for their knees within 1 month before. (3) Patients with the following knee symptoms in the more symptomatic side. Morning stiffness less than 30 minutes, Joint crepitus, Tenderness at the joint space, and palpable osteophytes (4) As comobidity, hypertension, diabetes, and hyperlipidemia under medication are allowed to enter the trial. (5) Patient who agreed to the following examinations. [X-rays]: the anteroposterior view of both knee joints in a standing position were taken and used to confirm the diagnosis. [Laboratory tests]: blood cell count (red blood cell, white blood cell, hemoglobin, hematocrit), biochemical examination (AST, ALT, ALP, BUN, creatinin, total cholesterol, triglyceride, uric acid), and routine urinalysis. (6) Patient who understand aim and contents the trial and cooperate with filling the questionnaire.
Exclusion criteria
Exclusion criteria: (1) Patients who had treatment for their knee at other hospital or clinic, i.e., who received therapeutic exercise, intraarticular injection, or NSAIDs within 4 weeks before the day of agreement to enter the trial. (2) Patients who had done or planned operation against the knee within 6 months before or after the day of agreement to enter the trial. (3) Patients who require intraarticular injection. (4) Patients who require aspiration of joint fluid. (5) Patients who have diseases requiring regular or intermittent use of steroid or non-steroidal anti-inflammatory drugs. (6) Patients who have articular cartilage injury or history of damage due to obvious trauma or septic arthritis. (7) Patients who were diagnosed as rheumatoid arthritis, gout, pseudogout, or collagen diseases. (8) Patients who had some difficulty to fill up their treatment diary. (9) Patients with cardiac dysfunction. (10) Patients with liver dysfunction. (11) Patients with renal dysfunction. (12) Patients with peptic ulcer. (13)Patients who had a history of bronchial asthma (Aspirin asthma, etc). (14) Patients who had a history of Anaphylaxis for NSAIDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional assessment including ADL: JKOM Assessment of utility and safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of pain: VAS. Assessment of adverse event in the trial period. | — |
Countries
Japan
Contacts
Public ContactTsutomu Iwaya
National Rehabilitation Center for Persons with Disabilities Director,Training Center
Outcome results
None listed