Treatment of knee osteoarthritis with small needle knife: a randomized controlled trial

Phase 1

Recruiting

• Conditions: Osteoarthritis of knee

• Registration Number: ITMCTR2000003312
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC knee osteoarthritis score;

Secondary Outcome Measures

Name	Time	Method
Patient's knee mobility measurement;Patient's knee musculoskeletal ultrasound;Patient's knee X-ray examination;Patient pain score (VAS);Patient's knee circumference measurement;Patient's plantar pressure test;