Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis
- Disease/Condition
- Osteoarthritis, Knee
- Drug/Device/Intervention
- Fu's Subcutaneous Needling
- Study type
- Interventional
- Intervention type
- device
- Primary sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Phase
- N/A
- Start date
- Mar 15, 2024
- End date
- Mar 01, 2026
- Enrollment
- 60 participants
Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.
The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory
 Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main
 questions it aims to answer are:
 
 Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective
 for pain relief and improvement in knee function in elder people with knee arthritis.
 
 Q2: From the biomechanical point of view, what is the mechanism by which FSN plays a
 therapeutic role in knee osteoarthritis (KOA)?
 
 Participants will:
 
 1. Will be randomly assigned to 2 groups. There will be 30 participants in each group.
 
 2. A group of patients will receive FSN monotherapy, while the other group will receive
 oral celecoxib and pantoprazole. Each patient will receive a 2-week course of treatment.
 
 3. Visual analogue scale (VAS), WOMAC, knee range of motion (ROM), gait analysis, and
 musculoskeletal ultrasonography (US) of lower extremity muscles will be assessed during
 treatment and in the follow-up.
 
 Researchers will compare FSN and celecoxib to see if FSN has better, or at least equivalent,
 efficacy than celecoxib, which is commonly used in clinical practice.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06328153
- Type
- Device Trial
Access comprehensive clinical trial information for NCT06328153 through Pure Global AI's free database. This phase not specified trial is sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine and is currently Not yet recruiting. The study focuses on Osteoarthritis, Knee. Target enrollment is 60 participants.
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