knee osteoarthritis
Conditions
Interventions
treatment group:Tizanidine hydrochloride tablets combined with imrecoxib tablets
control group:Oral imrecoxib tablets
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Those who do not meet one of the following circumstances are not eligible for selection: 1. Over 40 years old (including 40 years old) to 80 years old. 2. Meet the diagnostic criteria for knee osteoarthritis [Refer to the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2021 edition)" of the Joint Surgery Group, Branch of Orthopedics, Chinese Medical Association. 3. Patients measured on the Numerical Pain Rating Scale (VAS, range: 0-10) reported a pain score of not less than 4 points, and the pain presentation was continuous and stable in intensity for nearly 1 week. 4. Duration of pain =90 days. 5. One knee osteoarthritis grade Kellgren&Lawrence II or III. 6. Can walk without assistance. 7. Participants are required to avoid non-habitual physical activity throughout the study period. The subjects fully understand the content and process of the experiment and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: Any of the following circumstances are excluded: 1. Patients with severe osteoarthritis, obvious narrowing of joint space and indications for surgery. 2. Arthritis caused by dermatomyositis, gouty arthritis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus and other causes. 3. In addition to knee arthritis, such as bursitis, intermittent claudication disease and other diseases that can cause knee pain. 4. Chinese and Western drugs for the treatment of osteoarthritis other than experimental drugs should be used within 1 week before the use of the study drug or during the study period. Such as non-steroidal anti-inflammatory drugs (not more than 325mg/ day aspirin for the prevention of heart disease, except), analgesics, osteoarthritis symptoms relief drugs (diacreine, glucosamine and chondroitin sulfate, etc.), anti-anxiety drugs (doxepin, amitriptyline and loricas, etc.), Chinese patent medicines and other oral medicines and topical creams. 5. Patients who were treated with oral, suppository, or intravenous formulations of glucocorticoids within 4 weeks prior to use of the study drug. 6. Patients who received intra-articular drug injection (such as glucocorticoids, sodium hyaluronate, medical chitinose, etc.) within 3 months prior to the use of the study drug 7. Open knee injury or other knee surgery such as arthroscopy, arthroscopic debridement, and knee replacement occurred within 1 year before the use of the study drug. 8. Patients who need physical therapy and rehabilitation of lower limbs during the study. 9. Patients whose clinical manifestations cannot be assessed. 10. Serious heart disease (such as heart failure), kidney failure. 11. Patients with active gastrointestinal ulcers/bleeding, or who have had recurrent ulcers/bleeding in the past. 12. A history of hypersensitivity to any component of the investigational drug. 13. Women with pregnancy, suspected pregnancy, breastfeeding, or who refused to use contraception during the study period. 14. Severe liver damage. 15. Malignant tumors or a history of malignant tumors within 5 years prior to signing the informed consent form. 16. Patients who are known to be allergic to tizanidine, iricoxib or other coxib drugs, and sulfonamide. 17. Patients with asthma, urticaria, or allergic reactions induced by aspirin or other nonsteroidal anti-inflammatory drugs. 18. The researcher determined that other patients who are not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in VAS pain scores of the target knee joint from baseline at week 4 (motion status: walking).; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in target knee VAS pain scores from baseline at week 1, 2, 8, and 12 (movement status: walking).;2. Changes from baseline in the target knee WOMAC Pain Scale scores at weeks 1, 2, 4, 8, and 12.;3. Changes from baseline in the WOMAC Stiffness Scale score of the target knee joint at weeks 1, 2, 4, 8, and 12.;4. Changes from baseline in the target knee WOMAC Daily Activity Scale scores at week 1, 2, 4, 8 and 12;5. Changes from baseline in the target knee Composite WOMAC Scale scores at week 1, 2, 4, 8 and 12.; 6. Overall changes in patients with knee osteoarthritis (PGA) at week 1, 2, 4, 8, and 12.;7. The degree and frequency of the target knee pain recurrence after the end of treatment at week 4.;8. At the end of the 4th week, whether the target knee joint needs to be administered again to control the pain after drug withdrawal.;9. Whether the target knee joint adjusted its treatment plan after the first dose because of ineffective or ineffective treatment.; | — |
Countries
China
Contacts
Public ContactKang Pengde
West China Hospital of Sichuan University
Outcome results
None listed