NCT06453603

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jul 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

May 23, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

May 23, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

Pes Anserine BursitisSteroid InjectionPRP injection

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (VAS)

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

    6 months

Secondary Outcomes (1)

  • WOMAC score

    6 months

Study Arms (2)

PRP injection

EXPERIMENTAL

receive pes anserinus PRP injection

Drug: PRP injection

Corticosteroid injection

ACTIVE COMPARATOR

receive pes anserinus corticosteroid injection

Drug: corticosteroid injection

Interventions

Receive pes anserinus PRP injection

PRP injection

Receive pes anserinus corticosteroid injection

Corticosteroid injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Bursitis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Chavarat Jarungvittayakon, Assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 23, 2024

First Posted

June 11, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share