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Not yet recruitingNCT06453603Updated Jun 11, 2024

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

An interventional study of PRP injection and corticosteroid injection in Pes Anserine Bursitis, Steroid Injection and PRP Injection, sponsored by Ramathibodi Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by Ramathibodi Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Pes Anserine Bursitis
  • Steroid Injection
  • PRP Injection

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Keywords

  • Pes Anserine Bursitis
  • Steroid Injection
  • PRP injection
03

In context

Bursitis

383 studies on the registry are indexed under Bursitis; 111 are open to participants now.

This study's planned enrollment of 24 is below the median of 44 across 346 interventional studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Ramathibodi Hospital is the lead sponsor of 63 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    PRP injection

    receive pes anserinus PRP injection

    Drug: PRP injection

  • Active comparator
    Corticosteroid injection

    receive pes anserinus corticosteroid injection

    Drug: corticosteroid injection

Interventions

  • Receive pes anserinus PRP injection

  • Drugcorticosteroid injection

    Receive pes anserinus corticosteroid injection

06

What researchers measure

Primary outcomes

  1. Visual analogue scale (VAS)

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

    Time frame: 6 months

Secondary outcomes

  1. WOMAC score

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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Kuptniratsaikul V, Rattanachaiyanont M. Validation of a modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis. Clin Rheumatol. 2007 Oct;26(10):1641-5. doi: 10.1007/s10067-007-0560-y. Epub 2007 Feb 20. PubMed 17310271 ↗
  • Yoon HS, Kim SE, Suh YR, Seo YI, Kim HA. Correlation between ultrasonographic findings and the response to corticosteroid injection in pes anserinus tendinobursitis syndrome in knee osteoarthritis patients. J Korean Med Sci. 2005 Feb;20(1):109-12. doi: 10.3346/jkms.2005.20.1.109. PubMed 15716614 ↗
  • Saltzman BM, Leroux T, Meyer MA, Basques BA, Chahal J, Bach BR Jr, Yanke AB, Cole BJ. The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies. Am J Sports Med. 2017 Sep;45(11):2647-2653. doi: 10.1177/0363546516680607. Epub 2016 Dec 27. PubMed 28027657 ↗
  • Subotnick SI, Sisney P. Treatment of Achilles tendinopathy in the athlete. J Am Podiatr Med Assoc. 1986 Oct;76(10):552-7. doi: 10.7547/87507315-76-10-552. No abstract available. PubMed 3772761 ↗
  • Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21. PubMed 20970844 ↗
  • Wong MW, Tang YY, Lee SK, Fu BS, Chan BP, Chan CK. Effect of dexamethasone on cultured human tenocytes and its reversibility by platelet-derived growth factor. J Bone Joint Surg Am. 2003 Oct;85(10):1914-20. doi: 10.2106/00004623-200310000-00008. PubMed 14563798 ↗
  • Liu D, Ahmet A, Ward L, Krishnamoorthy P, Mandelcorn ED, Leigh R, Brown JP, Cohen A, Kim H. A practical guide to the monitoring and management of the complications of systemic corticosteroid therapy. Allergy Asthma Clin Immunol. 2013 Aug 15;9(1):30. doi: 10.1186/1710-1492-9-30. PubMed 23947590 ↗
  • Han SH, An HJ, Song JY, Shin DE, Kwon YD, Shim JS, Lee SC. Effects of corticosteroid on the expressions of neuropeptide and cytokine mRNA and on tenocyte viability in lateral epicondylitis. J Inflamm (Lond). 2012 Oct 30;9(1):40. doi: 10.1186/1476-9255-9-40. PubMed 23107345 ↗
  • Carofino B, Chowaniec DM, McCarthy MB, Bradley JP, Delaronde S, Beitzel K, Cote MP, Arciero RA, Mazzocca AD. Corticosteroids and local anesthetics decrease positive effects of platelet-rich plasma: an in vitro study on human tendon cells. Arthroscopy. 2012 May;28(5):711-9. doi: 10.1016/j.arthro.2011.09.013. Epub 2012 Jan 21. PubMed 22264830 ↗
  • Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285. PubMed 23997125 ↗
  • Everts P, Onishi K, Jayaram P, Lana JF, Mautner K. Platelet-Rich Plasma: New Performance Understandings and Therapeutic Considerations in 2020. Int J Mol Sci. 2020 Oct 21;21(20):7794. doi: 10.3390/ijms21207794. PubMed 33096812 ↗
  • Uysal F, Akbal A, Gokmen F, Adam G, Resorlu M. Prevalence of pes anserine bursitis in symptomatic osteoarthritis patients: an ultrasonographic prospective study. Clin Rheumatol. 2015 Mar;34(3):529-33. doi: 10.1007/s10067-014-2653-8. Epub 2014 May 6. PubMed 24797774 ↗
  • Kemp JA, Olson MA, Tao MA, Burcal CJ. Platelet-Rich Plasma versus Corticosteroid Injection for the Treatment of Lateral Epicondylitis: A Systematic Review of Systematic Reviews. Int J Sports Phys Ther. 2021 Jun 1;16(3):597-605. doi: 10.26603/001c.24148. PubMed 34123513 ↗
  • Gautam VK, Verma S, Batra S, Bhatnagar N, Arora S. Platelet-rich plasma versus corticosteroid injection for recalcitrant lateral epicondylitis: clinical and ultrasonographic evaluation. J Orthop Surg (Hong Kong). 2015 Apr;23(1):1-5. doi: 10.1177/230949901502300101. PubMed 25920633 ↗
  • Ben-Nafa W, Munro W. The effect of corticosteroid versus platelet-rich plasma injection therapies for the management of lateral epicondylitis: A systematic review. SICOT J. 2018;4:11. doi: 10.1051/sicotj/2017062. Epub 2018 Mar 21. PubMed 29561260 ↗
  • Anitua E, Sanchez M, Nurden AT, Nurden P, Orive G, Andia I. New insights into and novel applications for platelet-rich fibrin therapies. Trends Biotechnol. 2006 May;24(5):227-34. doi: 10.1016/j.tibtech.2006.02.010. Epub 2006 Mar 15. PubMed 16540193 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06453603
Lead sponsor
Ramathibodi Hospital
Responsible party
Thaned Ekthanaporn (Doctor, Ramathibodi Hospital) — Principal investigator
First posted
Jun 11, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 11, 2024

Study contacts

Thaned ekthanaporn
Contact
jame.longjohn@gmail.com
(66+)94-992-8544
Chavarat Jarungvittayakon, Assistant professor
Contact
(66+)02-201-1589

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Platelet rich plasma

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