A self-controlled trial treating patients with knee osteoarthritis using a nano-enabled Lidocaine delivery acupuncture needle(Lidocaine nd-Acu)
- Conditions
- knee osteoarthritis
- Registration Number
- ITMCTR2024000169
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1) age from 45 to 80 years old;
2) patients meet the diagnostic criteria for knee osteoarthritis according to the 2014 National Institute for Health and Clinical Excellence criteria of the United Kingdom;
3) In recent 6 months, Kellgren and Lawrecne's radiological diagnostic criteria were in line with Grade I to Grade III;
4) The average severity of knee pain in the past week was =4 points (0 points representing no pain, 10 points representing extreme pain, a total of 11 scales);
5) male or female;
6) patients who signed informed consent and volunteer to participate in this project.
1) patients with a history of knee replacement surgery;
2) knee pain caused by other diseases (e.g. joint loosening, infection, malignancy, autoimmune disease, trauma, etc.). Patients with acute and chronic periarticular synovitis, bursitis, ligamentitis and other soft tissue inflammation should be evaluated by doctors to decide whether to enter the group;
3) had undergone arthroscopy or intra-articular injection within 1 year;
4) pregnant or lactating women;
5) severe acute/chronic organic or mental illness;
6) coagulation disorders (such as hemophilia);
7) participated in other clinical studies in the past three months.
Study & Design
- Study Type
- Treatment study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster Universities Osteoarthritis index,WOMAC score;Venous blood plasma inflammatory factor IL-1/IL-6/TNF-a;
- Secondary Outcome Measures
Name Time Method Knee joint ultrasonography;TCM symptom scale score;LKSS score;