Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06328153
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-15
Brief Title:
Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis
Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Organization:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Overview
Official Title:
Biomechanically Based Fus Subcutaneous Needling Treatment for Senile Keen Osteoarthritis Protocol For a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 n30 and a drug group n30 All patients will give informed consent before participation and the trial is initiated after approval The Fus subcutaneous needlingFSN group underwent FSN treatment 3 times a week for 2 weeks while the drug group received oral celecoxib 02 gday for 2 weeks with a follow-up period of 2 weeks after the completion of treatment The primary outcome will be the visual analog scaleVASafter 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None