Effect of Home Exercise of Quadriceps for Knee Osteoarthritis; A Randomized Con-trolled Trial comparing with Non Steroidal Anti Inflammatory Drugs

UMIN ID: C000000268

Registered date:27/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Knee Osteoarthritis
• Date of first enrollment: 2003/03/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 sets consisted of 80 repetitions of the above quadriceps setting (20 times as one sets), each 2 sets in the morning and afternoon. Patients were basically instructed to do the exercise in sitting position with chair, and were also able to do in supine position if necessary. If patients wanted heavier weight at the ex-ercise they could add 1 or 2 kg as the ankle weight gradually. One or two sets of exer-cise are imposed as check at the clinical visit.
C1 (Control group): Non-steriodal anti-inflammatory drugs (NSAIDs) and fre-quent clinical visits. The patients were able to stop their drugs when they no longer re-quired treatment. They were also required to record exactly how many they had been taking medicine in a note. NSAIDs were limited only one of the three to prescribe. These were the top three used in Japan at the present; 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.

Outcome(s)

• Primary Outcome: (1) functional assessment including ADL: WOMAC (2) functional assessment including ADL: JKOM (3) QOL assessment: SF-36
• Secondary Outcome: Assessment of pain: VAS

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: The Japanese Orthopaedic Association
• Secondary Sponsor: The Japanese Clinical Orthopaedic Associa-tion The Japanese Society for Musculoskeletal Rehabilitation
• Source(s) of Monetary Support: None