Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome

Not Applicable

Not yet recruiting

• Conditions: Pes Anserine Bursitis; Steroid Injection; PRP Injection
• Interventions: Drug: PRP injection; Drug: corticosteroid injection

• Registration Number: NCT06453603
• Lead Sponsor: Ramathibodi Hospital

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.

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

Study Timeline

• Study First Submitted: 2024-05-23
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Start: 2024-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients with a localized knee infection or a disseminated infection within the past 3 months
• Patients with thyroid disorders, rheumatoid arthritis, or other types of knee arthritis
• Patients with abnormal blood coagulation or thrombocytopenia
• Patients who are pregnant
• Patients with any type of cancer
• Patients who cannot follow up with treatment until the end of the project
• Patients who are unwilling to participate in the project or wish to withdraw from the research project

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP injection	PRP injection	receive pes anserinus PRP injection
Corticosteroid injection	corticosteroid injection	receive pes anserinus corticosteroid injection

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	6 months	Pain relief outcome : Visual analogue scale (VAS) scale 0(minimum pain) to 10(maximum pain)

Secondary Outcome Measures

Name	Time	Method
WOMAC score	6 months	Functional outcomes : The Western Ontario and McMaster Universities Arthritis Index(WOMAC) version 3.01 Thai version