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NCT Number: NCT06453603

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP injection

Drug

Receive pes anserinus PRP injection

Corticosteroid injection

Drug

Receive pes anserinus corticosteroid injection

Primary outcomes

  1. 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

  1. WOMAC score

    Time frame: 6 months

    Functional outcomes : The Western Ontario and McMaster Universities Arthritis Index(WOMAC) version 3.01 Thai version

Study contacts

Contact information is provided by the study sponsor or research team.

Chavarat Jarungvittayakon, Assistant professor

CONTACT

(66+)02-201-1589

Thaned ekthanaporn

CONTACT

[email protected]

(66+)94-992-8544

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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