ITMCTR2000003312
Recruiting
Phase 1
Treatment of knee osteoarthritis with small needle knife: a randomized controlled trial
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who meet the stage I, II, III of Kellgren\-Lawrecne's radiological diagnostic criteria;
- •2\. KAS pain VAS score \>\= 4 points;
- •3\. The age is between 40\-70 years old, regardless of gender;
- •4\. Those who have not taken other related treatment drugs or adopted related treatment measures within 2 weeks;
- •5\. Participate voluntarily, sign the informed consent form, be willing to accept the trial, and follow the random grouping.
Exclusion Criteria
- •1\. Women who are pregnant or breastfeeding, or who have a pregnancy plan during the trial;
- •2\. Patients with severely life\-threatening cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system and other diseases or infectious diseases, who are unable to complete or are not suitable for related treatment and examination;
- •3\. Patients with local infection, ulceration, vascular nerve injury or deep abscess in the knee;
- •4\. Patients who have a history of severe knee trauma, or have undergone surgery or arthroscopy treatment;
- •5\. Patients with other bone diseases such as tuberculosis, tumors, rheumatism, rheumatoid arthritis, gouty arthritis and other bone diseases that are not osteoarthritis or knee pain caused by other diseases;
- •6\. Patients who have received oral hormonal drugs or knee closure therapy and other interventions within 1 month; or patients who have participated in other clinical trials within 3 months;
- •7\. People who are allergic to the medical devices involved in this trial; contraindications to the use of indomethacin plaster, such as those with a history of allergy to indomethacin, those with liver and kidney dysfunction (alanine aminotransferase (ALT), aspart The amino acid transaminase (AST) is more than 2 times the normal value, and the blood creatinine (cr) is more than the normal value). Patients who have induced asthma, urticaria or allergic reactions after taking aspirin or other non\-steroidal anti\-inflammatory drugs may have nonsteroidal Patients with a history of gastrointestinal bleeding or perforation after anti\-inflammatory drugs, patients with active gastrointestinal ulcer bleeding, or patients with previous recurrent ulcers / bleeds, patients with severe heart failure, perioperative coronary artery bypass surgery, etc .;
- •8\. Patients with bleeding tendency, such as long\-term use of anticoagulants such as warfarin and aspirin;
- •9\. Those who have a history of sedative hypnotics, opioid analgesics and alcohol abuse;
- •10\. Patients with cognitive impairment, or language communication impairment, unable to express accurately.
Outcomes
Primary Outcomes
Not specified
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