Effectiveness and safety of celecoxib (Celebrex 200 mg) combined with Joins in the treatment of degenerative knee osteoarthritis: a randomized controlled trial
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0005742
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 216
• Adults over 50
• Patients undergoing outpatient treatment in orthopedic surgery for osteoarthritis of the knee joint
• Patients diagnosed with Kellgren-Lawrence grade II or III osteoarthritis of the knee by imaging examination
• Patients with a pain VAS scale of 4 or more out of 10 with a pain in the knee joint during daily activities on flat ground
• Patients confirmed by the examiner for no abnormal results in blood tests, etc.
• Patients who are willing or able to follow doctor's instructions, including joint exercises
• Patients not participating in other clinical trials
• Patients who have received sufficient explanation for this clinical trial and agreed to participate
• Patients with secondary knee osteoarthritis
• Patients with hypersensitivity reactions and serious side effects to Celebrex or Joins
• Patients with inflammatory arthritis or crystalline arthritis
• Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
• Patients who underwent meniscus surgery on the knee joint in the painful area
• Patients who underwent total knee arthroplasty within 180 days of the knee joint opposite the pain area
• If there is construction or deformation of the knee joint in the pain area
• Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
• Hemoglobin A1c level >8% of patients not managed by diabetes
• Patients with high blood pressure with poor blood pressure control (Systolic Blood Pressure of> 150 mmHg or Diastolic Blood Pressure> 95 mmHg)
• Patients taking PPI drugs for recurrent upper gastrointestinal ulcer or inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
• Patients with abnormal liver function (ALT)> 2.0 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine> 2.0 times ULN)
• Patients who took excessive narcotic analgesics for pain in the affected area before the clinical trial
• Patients scheduled for surgery during the clinical trial period
• Patients who received intraarticular injection treatment into the painful area of ??the knee within 3 months prior to the first visit
• Patients who received systemic steroid treatment within 3 months prior to their first visit
• Pregnant or lactating women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster University Osteoarthritis (WOMAC) subscale
- Secondary Outcome Measures
Name Time Method Pain Visual Analogue Scale (VAS);Brief pain inventory (BPI);SF-36 score;Biomarker (CTX-1, CTX-2. COMP, HA, NTX-1);X-ray(Joint space width, Kellgren-Lawrence grade);Adverse event