Fire needle of different treatment frequencies in knee osteoarthritis: a pilot randomised controlled trial
- Conditions
- Knee osteoarthritis
- Registration Number
- ITMCTR2100004377
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Eligible participants were men or women between the ages of 45 and 75 years;
2. Diagnosed with KOA according to the 2014 National Institute of Health and Clinical Optimization Standards; had symptoms related to KOA for 6 months;
3. Met the radiologic confirmation of KOA (Kellgren–Lawrence grade II to IV);
4. had average knee pain 4 on an 11-point numerical rating scale (NRS) in the past week;
5. and agreed to refrain from the routine use of analgesics; If participants need rescue medication, they were provided with Ibuprofen (SK&F Co, Ltd, Tianjin, China;0.4 g/8 hour).
The exclusion criteria were:
1. history of knee surgery or waiting for surgery;
2. knee pain caused by other diseases (eg, joint loose bodies, severe effusion of the joint cavity, malignant tumors, and autoimmune diseases);
3. history of arthroscopy in the past year or intra-articular injection in the past 4 months;
4. acupuncture treatment in the past 3 months;
5. severe organic or mental diseases;
6. pregnant or lactating women;
7. coagulation disorders; needle phobia;
8. and involvement in other clinical trials in the past 3 months;
9. Medical history of pacemaker installation, history of metal allergy or fear of needle, fear of fire needle.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The response rate;
- Secondary Outcome Measures
Name Time Method Mechanical Withdrawal Threshold;WOMAC SCALE;Patient Global Impression of Change;Standing and Walking Test;BPI SCALE;Pressure Pain Threshold;SF-12;