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Clinical Trials/NCT06453603
NCT06453603
Not yet recruiting
Not Applicable

Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome, Randomized Controlled Trial Study

Ramathibodi Hospital0 sites24 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
PRP injection
Conditions
Pes Anserine Bursitis
Sponsor
Ramathibodi Hospital
Enrollment
24
Primary Endpoint
Visual analogue scale (VAS)
Status
Not yet recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thaned Ekthanaporn

Doctor

Ramathibodi Hospital

Eligibility Criteria

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

Arms & Interventions

PRP injection

receive pes anserinus PRP injection

Intervention: PRP injection

Corticosteroid injection

receive pes anserinus corticosteroid injection

Intervention: corticosteroid injection

Outcomes

Primary Outcomes

Visual analogue scale (VAS)

Time Frame: 6 months

Pain relief outcome : Visual analogue scale (VAS) scale 0(minimum pain) to 10(maximum pain)

Secondary Outcomes

  • WOMAC score(6 months)

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