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Effect of non-steroidal anti-inflammatory drugs external patch for Knee Osteoarthritis; An Open label Randomized Controlled Trial.

Phase 3
Conditions
Knee Osteoarthritis
Registration Number
JPRN-C000000283
Lead Sponsor
The Japanese Society for Musculoskeletal Rehabilitation
Brief Summary

ocal application of a plaster with non- steroidal anti-inflammatory drugs (NSAIDs) leads to the same level of improvement for knee osteoarthritis in Japanese as oral NSAIDs. Doi T, Akai M, Fujino K, et al.: Effect of non-steroidal anti-inflammatory drug plasters for knee osteoarthritis in Japanese: A randomized controlled trial. Modern Rheumatology 20(1): 24-33, 2010

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Functional assessment including ADL: JKOM Assessment of utility and safety.
Secondary Outcome Measures
NameTimeMethod
Assessment of pain: VAS. Assessment of adverse event in the trial period.
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