NCT06328153

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was a randomised, parallel-controlled, single-center prospective clinical study, which included 60 participants, with an FSN group (n=30) and a drug group (n=30). All patients will give informed consent before participation and the trial is initiated after approval. The Fu's subcutaneous needling(FSN) group underwent FSN treatment 3 times a week for 2 weeks, while the drug group received oral celecoxib 0.2 g/day for 2 weeks, with a follow-up period of 2 weeks after the completion of treatment. The primary outcome will be the visual analog scale（VAS）after two weeks of treatment. The secondary outcomes will be self-reported knee stiffness using the WOMAC Index, joint active range of motion test, three-dimensional gait analysis, and Shear wave elastic imaging technology analysis in lower limb muscles. The results of this trial will be disseminated through publication in peer-reviewed journals.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Fu's Subcutaneous Needling	Operation of the FSN will follow the KOA's Fu's Subcutaneous Needling Treatment Code of Practice24. After routine disinfection, a disposable Fu's subcutaneous needle ( Nanjing-Paifu Medical Technology Co., Ltd., Jiangsu, China ) is inserted parallel into the subcutaneous loose connective tissue of the pathological tight muscles ( gastrocnemius muscle, tibial anterior muscle and quadriceps femoris muscle ). The FSN needle is operated in a swaying movement. The fan angle is approximately 60°; perform a total of 45 round trips in 30 seconds. Swaying is accompanied by reperfusion approach: 20 sweeps with 10 seconds of reperfusion approach as a group, 3 groups for each pathological tight muscle. The reperfusion approach requires active, short and sharp contractions of the pathological tight muscle. The muscle alternates contraction and relaxation. The FSN group is treated 3 times a week for 2 weeks.
DRUG	Celecoxib	Participants in the drug group will receive celecoxib (capsule) 200mg every day continuously for 2 weeks.

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2024-03-25
• Last updated: 2024-03-25