Knee Osteoarthritis
Conditions
Interventions
E1 (trial) group: Isotonic quadriceps exer-cise and frequent clinical visits. The exercise was instructed to maintain 3-5 seconds by means of straight leg raising. Patients performed at least 4 set
loxoprofen sodium, diclofenac sodium, and zaltoprofen.
E2 (trial) group: Isotonic quadriceps exer-cise and fewer clinical visits
C2 (Control group): NSAIDs and fewer clinical visits.
Sponsors
The Japanese Orthopaedic Association
The Japanese Clinical Orthopaedic Associa-tion The Japanese Society for Musculoskeletal Rehabilitation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients satisfying the following condi-tions (1)-(6) are included. (1) Outpatients aged 50-80 years old with knee pain. Both men and women are able to enter the trial. (2) New patients for medical institution concerned, who receiving no treatment for their knee within 1 month before. (3) Patients with the following knee symp-toms in the more symptomatic side. Morning stiffness less than 30 minutes, Joint crepitus Tenderness at the joint space, and palpable osteophytes (4) As complications hypertension, diabetes, and hyperlipidemia under medication are allowed to enter the trial. (5) Patient who agreed to the following ex-aminations. [X-rays]: the anteroposterior view of both knee joints in a standing posi-tion were taken and used to confirm the di-agnosis. [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 urinaly-sis. These examinations are performed once at the entry agreement time. (6) Patient who understand aim and contents the trial and cooperate with filling the ques-tionnaire.
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 opera-tion against the knee within 6 months before or after the day of agreement to enter the trial (3) Patients who require intra-articular in-jection (4) Patients who take bisphosphonate, vita-min K, or hormone replacement therapy (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 rheu-matoid arthritis, gout, pseudogout, or colla-gen diseases (8) Patients who had some difficulty to fill up their treatment diary (9) Patients who had a history of cerebral vascular accident within 6 months before the day of agreement to enter the trial (10) Patients who had a history of myocar-dial infarction within 6 months before the day of agreement to enter the trial (11) Patients who received treatment for cardiac failure (12) Patients with liver dysfunction (13) Patients with renal dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) functional assessment including ADL: WOMAC (2) functional assessment including ADL: JKOM (3) QOL assessment: SF-36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of pain: VAS | — |
Countries
Japan
Contacts
Public ContactTsutomu Iwaya
National Rehabilitation Center for Persons with Disabilities Training Center
Outcome results
None listed