Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome
NCT ID: NCT06453603
Last Updated: 2024-06-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-07-01
Study Completion Date
2026-12-31
Brief Summary
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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.
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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Detailed Description
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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
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
Conditions
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Pes Anserine Bursitis
Steroid Injection
PRP Injection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
Study Groups
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PRP injection
receive pes anserinus PRP injection
Group Type
EXPERIMENTAL
PRP injection
Intervention Type
DRUG
Receive pes anserinus PRP injection
Corticosteroid injection
receive pes anserinus corticosteroid injection
Group Type
ACTIVE_COMPARATOR
corticosteroid injection
Intervention Type
DRUG
Receive pes anserinus corticosteroid injection
Interventions
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PRP injection
Receive pes anserinus PRP injection
Intervention Type
DRUG
corticosteroid injection
Receive pes anserinus corticosteroid injection
Intervention Type
DRUG
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ramathibodi Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Thaned Ekthanaporn
Doctor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Central Contacts
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Chavarat Jarungvittayakon, Assistant professor
Role: CONTACT
(66+)02-201-1589
References
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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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
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pending 00
Identifier Type: -
Identifier Source: org_study_id
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