Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-27 @ 4:14 AM
Study NCT ID:
NCT06453603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome
Sponsor:
Ramathibodi Hospital
Organization:
Study Overview
Official Title:
Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome, Randomized Controlled Trial Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 research is to study the efficacy of treatment between PRP injection and corticosteroid injection in patients with pes anserinus bursitis. The research question is whether PRP can reduce pain more effectively than corticosteroids.
The study is divided into two groups: one group receiving PRP injections and the second group receiving corticosteroid injections. Treatment outcomes will be monitored at four time points: baseline, 4 weeks, 12 weeks, and 24 weeks. The outcomes will be measured using the VAS and WOMAC scores.
The study is divided into two groups: one group receiving PRP injections and the second group receiving corticosteroid injections. Treatment outcomes will be monitored at four time points: baseline, 4 weeks, 12 weeks, and 24 weeks. The outcomes will be measured using the VAS and WOMAC scores.
Detailed Description:
Randomization of patient with pes anserinus bursitis at opd od ramathibodi hospital.
Objective : to study the efficacy of treatment between PRP injection and corticosteroid injection in patients with pes anserinus bursitis
Medhods :
A randomized controlled trial , Single blinded Participants : Patients with pes anserinus bursitis Randomization : Randomization will be performed using the software STATA 16.0 (StataCorp, College Station, Texas, USA). A various blocked randomization method
Interventions and control :
* Experimental groups : PRP injection 4 ml
* Control groups : Steroid injection , Triamcinolone acetonide(40mg/ml) 1 ml + 1%Lidocaine without adrenaline 3 ml = 4ml By Orthopedic surgeon with ultrasound guide.
Allocation and concealment :
A central randomization service will prepare sealed envelopes containing the assigned treatment for each patient.
The envelopes will be kept in secure location until Break the concealment at outpatient orthopedics department , Ramathibodi hospital
Blinding :
Randomized controlled trial study, Single blinded The assessor who will be follow up the patients, will be blinded to the group assignments.
Outcome measures:
Visual Analogue Scale (VAS) , Womac scores
Follow up:
at 4 weeks, 12 weeks, and 24 weeks after injection.
Statistic analysis:
STATA 16.0, StataCorp, College Station, Texas, USA Analysis Demographic data : mean, SD Mean difference in patient-relevant outcomes : Independent T- test
Objective : to study the efficacy of treatment between PRP injection and corticosteroid injection in patients with pes anserinus bursitis
Medhods :
A randomized controlled trial , Single blinded Participants : Patients with pes anserinus bursitis Randomization : Randomization will be performed using the software STATA 16.0 (StataCorp, College Station, Texas, USA). A various blocked randomization method
Interventions and control :
* Experimental groups : PRP injection 4 ml
* Control groups : Steroid injection , Triamcinolone acetonide(40mg/ml) 1 ml + 1%Lidocaine without adrenaline 3 ml = 4ml By Orthopedic surgeon with ultrasound guide.
Allocation and concealment :
A central randomization service will prepare sealed envelopes containing the assigned treatment for each patient.
The envelopes will be kept in secure location until Break the concealment at outpatient orthopedics department , Ramathibodi hospital
Blinding :
Randomized controlled trial study, Single blinded The assessor who will be follow up the patients, will be blinded to the group assignments.
Outcome measures:
Visual Analogue Scale (VAS) , Womac scores
Follow up:
at 4 weeks, 12 weeks, and 24 weeks after injection.
Statistic analysis:
STATA 16.0, StataCorp, College Station, Texas, USA Analysis Demographic data : mean, SD Mean difference in patient-relevant outcomes : Independent T- test
Study Oversight
Has Oversight DMC:
True
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?: