Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-27 @ 4:14 AM
Study NCT ID:
NCT06453603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale (VAS)', 'timeFrame': '6 months', 'description': 'Pain relief outcome : Visual analogue scale (VAS) scale 0(minimum pain) to 10(maximum pain)'}], 'secondaryOutcomes': [{'measure': 'WOMAC score', 'timeFrame': '6 months', 'description': 'Functional outcomes : The Western Ontario and McMaster Universities Arthritis Index(WOMAC) version 3.01 Thai version'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pes Anserine Bursitis', 'Steroid Injection', 'PRP injection'], 'conditions': ['Pes Anserine Bursitis', 'Steroid Injection', 'PRP Injection']}, 'referencesModule': {'references': [{'pmid': '17310271', 'type': 'RESULT', 'citation': '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': '15716614', 'type': 'RESULT', 'citation': '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': '28027657', 'type': 'RESULT', 'citation': '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': '3772761', 'type': 'RESULT', 'citation': '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': '20970844', 'type': 'RESULT', 'citation': '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': '14563798', 'type': 'RESULT', 'citation': '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': '23947590', 'type': 'RESULT', 'citation': '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': '23107345', 'type': 'RESULT', 'citation': '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': '22264830', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23997125', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '33096812', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24797774', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34123513', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '25920633', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '29561260', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '16540193', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': 'Randomization of patient with pes anserinus bursitis at opd od ramathibodi hospital.\n\nObjective : to study the efficacy of treatment between PRP injection and corticosteroid injection in patients with pes anserinus bursitis\n\nMedhods :\n\nA 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\n\nInterventions and control :\n\n* Experimental groups : PRP injection 4 ml\n* Control groups : Steroid injection , Triamcinolone acetonide(40mg/ml) 1 ml + 1%Lidocaine without adrenaline 3 ml = 4ml By Orthopedic surgeon with ultrasound guide.\n\nAllocation and concealment :\n\nA central randomization service will prepare sealed envelopes containing the assigned treatment for each patient.\n\nThe envelopes will be kept in secure location until Break the concealment at outpatient orthopedics department , Ramathibodi hospital\n\nBlinding :\n\nRandomized controlled trial study, Single blinded The assessor who will be follow up the patients, will be blinded to the group assignments.\n\nOutcome measures:\n\nVisual Analogue Scale (VAS) , Womac scores\n\nFollow up:\n\nat 4 weeks, 12 weeks, and 24 weeks after injection.\n\nStatistic analysis:\n\nSTATA 16.0, StataCorp, College Station, Texas, USA Analysis Demographic data : mean, SD Mean difference in patient-relevant outcomes : Independent T- test'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Over 18 years old\n* Patients diagnosed with Pes Anserine Pain Syndrome\n* Patients willing to participate in the research project by signing a consent form\n\nExclusion Criteria:\n\n* Patients with a localized knee infection or a disseminated infection within the past 3 months\n* Patients with thyroid disorders, rheumatoid arthritis, or other types of knee arthritis\n* Patients with abnormal blood coagulation or thrombocytopenia\n* Patients who are pregnant\n* Patients with any type of cancer\n* Patients who cannot follow up with treatment until the end of the project\n* Patients who are unwilling to participate in the project or wish to withdraw from the research project'}, 'identificationModule': {'nctId': 'NCT06453603', 'briefTitle': 'Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome, Randomized Controlled Trial Study', 'orgStudyIdInfo': {'id': 'pending 00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP injection', 'description': 'receive pes anserinus PRP injection', 'interventionNames': ['Drug: PRP injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroid injection', 'description': 'receive pes anserinus corticosteroid injection', 'interventionNames': ['Drug: corticosteroid injection']}], 'interventions': [{'name': 'PRP injection', 'type': 'DRUG', 'description': 'Receive pes anserinus PRP injection', 'armGroupLabels': ['PRP injection']}, {'name': 'corticosteroid injection', 'type': 'DRUG', 'description': 'Receive pes anserinus corticosteroid injection', 'armGroupLabels': ['Corticosteroid injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Thaned ekthanaporn', 'role': 'CONTACT', 'email': 'jame.longjohn@gmail.com', 'phone': '(66+)94-992-8544'}, {'name': 'Chavarat Jarungvittayakon, Assistant professor', 'role': 'CONTACT', 'phone': '(66+)02-201-1589'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Thaned Ekthanaporn', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}