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

Official title

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

Overview

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.

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

Interventions

• Drug PRP injection
  Receive pes anserinus PRP injection
• Drug corticosteroid injection
  Receive pes anserinus corticosteroid injection

Primary outcome measures

• Visual analogue scale (VAS) [Time frame: 6 months]

Secondary outcome measures (1)

• WOMAC score [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 23107345

Identifiers

NCT: NCT06453603 · pending 00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗