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NCT06328153Not yet recruiting

Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis

Biomechanically Based Fu's Subcutaneous Needling Treatment for Senile Keen Osteoarthritis: Protocol For a Randomized Controlled Trial
Guangdong Provincial Hospital of Traditional Chinese MedicineClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Osteoarthritis, Knee
Drug/Device/Intervention
Fu's Subcutaneous Needling
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Timeline & enrollment
Phase
N/A
Start date
Mar 15, 2024
End date
Mar 01, 2026
Enrollment
60 participants
Primary outcome

Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.

Summary

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.

ICD-10 classifications
Chronic instability of kneeInjuries to the knee and lower legGonarthrosis [arthrosis of knee]Dislocation, sprain and strain of joints and ligaments of kneeSprain and strain of other and unspecified parts of knee
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06328153
Type
Device Trial
About this record

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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