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

June 10, 2024 updated by: Thaned Ekthanaporn, Ramathibodi Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chavarat Jarungvittayakon, Assistant professor
  • Phone Number: (66+)02-201-1589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Over 18 years old
  • Patients diagnosed with Pes Anserine Pain Syndrome
  • Patients willing to participate in the research project by signing a consent form

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP injection
receive pes anserinus PRP injection
Drug: PRP injection
Receive pes anserinus PRP injection
Active Comparator: Corticosteroid injection
receive pes anserinus corticosteroid injection
Drug: corticosteroid injection
Receive pes anserinus corticosteroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS)
Time Frame: 6 months
Pain relief outcome : Visual analogue scale (VAS) scale 0(minimum pain) to 10(maximum pain)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC score
Time Frame: 6 months
Functional outcomes : The Western Ontario and McMaster Universities Arthritis Index(WOMAC) version 3.01 Thai version
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pending 00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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