Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
Study NCT ID:
NCT06854666
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2025-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Leukocyte-Poor Platelet-Rich Plasma Reduces Pain Symptoms in the Treatment of the Lateral Epicondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}, {'id': 'D034062', 'term': 'Insomnia, Fatal Familial'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D017096', 'term': 'Prion Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Healing Process of Tendons', 'timeFrame': '12 months', 'description': 'Healing Process of Tendons: The healing progress of the repaired tendons will be monitored using MRI imaging at before and after 24 weeks post-treatment.'}], 'primaryOutcomes': [{'measure': 'Improvement in Pain (VAS Score)', 'timeFrame': '12 months', 'description': 'Description: This study aims to evaluate whether PRP reduces pain in patients with lateral epicondylar tendinopathy (LET).\n\nAssessment Tool: Visual Analog Scale (VAS) Scale: 0 to 10 (0 = no pain, 10 = worst possible pain) Higher scores indicate worse pain outcomes. Time Frame: 12 months'}, {'measure': 'Grip Strength', 'timeFrame': '12 months', 'description': 'Grip Strength: The study includes grip strength testing with isometric grip strenght measure BTE, which is a primary measure of functional improvement following treatment.'}, {'measure': 'Improvement in Functional Outcomes (Oxford Elbow Score - OES)', 'timeFrame': '12 months', 'description': 'Description: This study will assess whether PRP improves elbow function and daily activity performance in LET patients.\n\nAssessment Tool: Oxford Elbow Score (OES) Scale: 0 to 48 (0 = worst function/pain, 48 = best function/pain) Higher scores indicate better functional outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tennis elbow', 'prp'], 'conditions': ['Tennis Elbow', 'Lateral Epicondylitis', 'Lateral Epicondylitis (tennis Elbow)', 'PRP Injection', 'PRP and Physiotherapy']}, 'referencesModule': {'references': [{'pmid': '24748436', 'type': 'BACKGROUND', 'citation': 'Kushida S, Kakudo N, Morimoto N, Hara T, Ogawa T, Mitsui T, Kusumoto K. Platelet and growth factor concentrations in activated platelet-rich plasma: a comparison of seven commercial separation systems. J Artif Organs. 2014 Jun;17(2):186-92. doi: 10.1007/s10047-014-0761-5. Epub 2014 Apr 20.'}, {'pmid': '19187989', 'type': 'BACKGROUND', 'citation': 'Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.'}, {'pmid': '23001116', 'type': 'BACKGROUND', 'citation': 'Chaudhury S, de La Lama M, Adler RS, Gulotta LV, Skonieczki B, Chang A, Moley P, Cordasco F, Hannafin J, Fealy S. Platelet-rich plasma for the treatment of lateral epicondylitis: sonographic assessment of tendon morphology and vascularity (pilot study). Skeletal Radiol. 2013 Jan;42(1):91-7. doi: 10.1007/s00256-012-1518-y. Epub 2012 Sep 22.'}, {'pmid': '6350485', 'type': 'BACKGROUND', 'citation': 'Fulginiti VA. A new pertussis vaccine: hope for the future? J Infect Dis. 1983 Jul;148(1):146-7. doi: 10.1093/infdis/148.1.146. No abstract available.'}, {'pmid': '26962506', 'type': 'BACKGROUND', 'citation': 'Palacio EP, Schiavetti RR, Kanematsu M, Ikeda TM, Mizobuchi RR, Galbiatti JA. Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial. Rev Bras Ortop. 2016 Jan 13;51(1):90-5. doi: 10.1016/j.rboe.2015.03.014. eCollection 2016 Jan-Feb.'}, {'pmid': '3328738', 'type': 'BACKGROUND', 'citation': 'Dronamraju KR. The origins of human gene mapping. With particular reference to the contributions of J. B. S. Haldane. Genomics. 1987 Nov;1(3):270-6. doi: 10.1016/0888-7543(87)90054-1.'}, {'pmid': '26393174', 'type': 'BACKGROUND', 'citation': 'Yadav R, Kothari SY, Borah D. Comparison of Local Injection of Platelet Rich Plasma and Corticosteroids in the Treatment of Lateral Epicondylitis of Humerus. J Clin Diagn Res. 2015 Jul;9(7):RC05-7. doi: 10.7860/JCDR/2015/14087.6213. Epub 2015 Jul 1.'}, {'pmid': '25920633', 'type': 'BACKGROUND', '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': '17962514', 'type': 'BACKGROUND', 'citation': 'Italiano JE Jr, Richardson JL, Patel-Hett S, Battinelli E, Zaslavsky A, Short S, Ryeom S, Folkman J, Klement GL. Angiogenesis is regulated by a novel mechanism: pro- and antiangiogenic proteins are organized into separate platelet alpha granules and differentially released. Blood. 2008 Feb 1;111(3):1227-33. doi: 10.1182/blood-2007-09-113837. Epub 2007 Oct 25.'}, {'pmid': '17397313', 'type': 'BACKGROUND', 'citation': 'El-Sharkawy H, Kantarci A, Deady J, Hasturk H, Liu H, Alshahat M, Van Dyke TE. Platelet-rich plasma: growth factors and pro- and anti-inflammatory properties. J Periodontol. 2007 Apr;78(4):661-9. doi: 10.1902/jop.2007.060302.'}, {'pmid': '17197209', 'type': 'BACKGROUND', 'citation': 'Cieslik-Bielecka A, Gazdzik TS, Bielecki TM, Cieslik T. Why the platelet-rich gel has antimicrobial activity? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103(3):303-5; author reply 305-6. doi: 10.1016/j.tripleo.2006.08.034. Epub 2007 Jan 2. No abstract available.'}, {'pmid': '24960641', 'type': 'BACKGROUND', 'citation': 'Filardo G, Kon E, Di Matteo B, Di Martino A, Tesei G, Pelotti P, Cenacchi A, Marcacci M. Platelet-rich plasma injections for the treatment of refractory Achilles tendinopathy: results at 4 years. Blood Transfus. 2014 Oct;12(4):533-40. doi: 10.2450/2014.0289-13. Epub 2014 Jun 19.'}, {'pmid': '24932440', 'type': 'BACKGROUND', 'citation': 'Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan.'}, {'pmid': '23352397', 'type': 'BACKGROUND', 'citation': 'Baksh N, Hannon CP, Murawski CD, Smyth NA, Kennedy JG. Platelet-rich plasma in tendon models: a systematic review of basic science literature. Arthroscopy. 2013 Mar;29(3):596-607. doi: 10.1016/j.arthro.2012.10.025. Epub 2013 Jan 24.'}, {'pmid': '22802273', 'type': 'BACKGROUND', 'citation': 'Mazzocca AD, McCarthy MB, Chowaniec DM, Dugdale EM, Hansen D, Cote MP, Bradley JP, Romeo AA, Arciero RA, Beitzel K. The positive effects of different platelet-rich plasma methods on human muscle, bone, and tendon cells. Am J Sports Med. 2012 Aug;40(8):1742-9. doi: 10.1177/0363546512452713. Epub 2012 Jul 16.'}, {'pmid': '21422467', 'type': 'BACKGROUND', 'citation': 'Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.'}]}, 'descriptionModule': {'briefSummary': "Lateral epicondylar tendinopathy (LET), or tennis elbow, is a degenerative condition affecting the forearm's extensor tendons. It commonly leads to pain, reduced grip strength, and impaired function, particularly in individuals performing repetitive wrist and forearm movements. Standard treatments, including physiotherapy, braces, and anti-inflammatory medications, provide relief but do not always lead to full recovery. Platelet-rich plasma (PRP) has gained interest as a regenerative therapy with the potential to enhance tendon healing and improve clinical outcomes.\n\nThis randomized, double-blind, placebo-controlled trial aims to evaluate PRP's effectiveness in treating LET, comparing it to leukocyte-rich PRP (L-PRP) and saline (placebo). Additionally, it assesses the composition of PRP and its role in tendon regeneration.\n\nThe study will enroll 80 patients diagnosed with LET, meeting predefined clinical criteria. Participants will be randomized into three groups (PRP, L-PRP, saline) and receive two injections (day 0 and day 7). PRP will be prepared using a standardized protocol to ensure consistency.\n\nPatients will undergo clinical evaluations (VAS, Mayo Elbow Score, SECEC Elbow Score), grip strength testing, and MRI scans at baseline and 24 weeks post-treatment. The PRP composition will be analyzed in a laboratory. Follow-ups will be conducted at 12, 24, and 54 weeks to monitor pain reduction, functional improvement, and tendon healing.\n\nThis study will provide critical insights into PRP's therapeutic potential, helping refine treatment approaches for LET and improve patient outcomes.", 'detailedDescription': 'Detailed Description\n\nStudy Rationale\n\nLateral epicondylar tendinopathy (LET), commonly referred to as tennis elbow, is a chronic degenerative condition affecting the common extensor tendon (CET) at the lateral epicondyle of the humerus. It is commonly observed in individuals engaged in repetitive wrist and forearm movements, such as athletes, manual laborers, and office workers. The primary pathological mechanism involves microtears leading to pain, reduced grip strength, and impaired function.\n\nConservative treatments, including physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and bracing, often provide temporary symptom relief but do not facilitate tendon regeneration. Corticosteroid injections may offer short-term pain relief but have been associated with tendon degeneration and higher recurrence rates. Given the limitations of these treatments, platelet-rich plasma (PRP) has emerged as a promising biological therapy due to its high concentration of growth factors that promote tissue healing, angiogenesis, and anti-inflammatory effects.\n\nHowever, the optimal formulation of PRP remains controversial. Some studies suggest that leukocyte-rich PRP (L-PRP) may enhance the inflammatory response and accelerate healing, while others indicate that leukocyte-poor PRP (LP-PRP) may have superior effects by reducing excessive inflammation. The cellular composition of PRP is not standardized across clinical studies, leading to variability in treatment outcomes. This study seeks to clarify the role of PRP in LET treatment, determine whether L-PRP offers superior benefits, and evaluate its effects on pain relief, functional recovery, and tendon healing over time.\n\nStudy Design and Methodology\n\nThis is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of PRP and L-PRP, saline compared to saline injections in treating LET. The study will enroll 80 symptomatic patients diagnosed with LET based on clinical criteria. Patients will be randomly assigned to one of the three treatment groups:\n\nPRP Group (n=20): Standard platelet-rich plasma injection\n\nL-PRP Group (n=20): Leukocyte-rich platelet-rich plasma injection\n\nSaline Group (Control) (n=20): Placebo (saline) injection\n\nBoth PRP and L-PRP will be prepared using a standardized, non-commercial protocol to ensure consistency in cellular composition. Blinding procedures will ensure that neither the patients nor the evaluating clinicians know which treatment is administered.\n\nPatient Selection Criteria\n\nInclusion Criteria:\n\nAge 18-65 years\n\nDiagnosed with chronic lateral epicondylitis (duration \\>6 months)\n\nPositive clinical tests: pain on resisted wrist extension and decreased grip strength\n\nWritten informed consent\n\nExclusion Criteria:\n\nPrevious elbow surgery or PRP treatment\n\nCorticosteroid injections within the past 3 months\n\nSystemic inflammatory or autoimmune diseases\n\nPregnancy or breastfeeding\n\nNeurological conditions affecting upper limb function\n\nPIN syndrome\n\nTreatment Protocol\n\nPre-Treatment Evaluation:\n\nAll patients will undergo:\n\nClinical assessment of pain and function\n\nVAS and Oxford Elbow Score questionnaires\n\nGrip strength testing using BTE\n\nMRI imaging of the affected elbow (baseline)\n\nInjection Procedure:\n\nBlood Collection: 30 ml of venous blood will be drawn from each patient\n\nCentrifugation: Blood will be centrifuged at 2054 g for 7 minutes to separate PRP fractions\n\nPRP/L-PRP Preparation: The appropriate PRP fraction will be extracted (with or without leukocytes)\n\nInjection: 2 ml of PRP or L-PRP will be injected into the CET, with 1 ml retained for laboratory analysis\n\nControl Group: Patients will receive an equivalent saline injection following the same procedure\n\nPost-Treatment Rehabilitation:\n\nGuided physiotherapy program focusing on eccentric strengthening\n\nUse of elbow braces during daily activities\n\nActivity modification guidelines\n\nOutcome Measures and Follow-Up\n\nPrimary Outcome:\n\nPain reduction measured by VAS score\n\nSecondary Outcomes:\n\nFunctional improvement assessed using Oxford Elbow Score\n\nGrip strength recovery using a digital dynamometer BTE Structural tendon healing assessed via MRI at baseline and 24 weeks post-treatment\n\nFollow-Up Schedule:\n\nWeek 0: Baseline assessments and first injection\n\nWeek 1: Second injection\n\nWeek 12: First follow-up visit (VAS, Oxford Elbow Score, grip strength)\n\nWeek 24: Second follow-up visit (MRI assessment, VAS, Oxford Elbow Score, grip strength)\n\nWeek 54: Final follow-up visit (long-term clinical evaluation, VAS, Oxford Elbow Score, grip strength)\n\nLaboratory Analysis\n\nPRP samples will be analyzed for platelet concentration, leukocyte content, and growth factor levels\n\nComparative analysis between PRP and L-PRP to correlate biological composition with clinical outcomes\n\nExpected Impact and Clinical Relevance\n\nThis study aims to establish a standardized PRP protocol for LET treatment and determine whether PRP offers superior benefits compared to conventional approaches. The results will provide:\n\nHigh-quality evidence for clinicians regarding PRP effectiveness\n\nGuidance on PRP formulation (leukocyte-rich vs. leukocyte-poor)\n\nObjective MRI data to track structural healing of the common extensor tendon\n\nImproved treatment strategies to enhance patient recovery and reduce recurrence rates\n\nBy correlating PRP composition with clinical and imaging outcomes, this trial will help refine biologic treatment strategies for chronic tendinopathies, ultimately improving evidence-based management of LET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first-time diagnosis of chronic lateral epicondylitis with a duration of at least 1 month, age of 18 years or more, and signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* pregnancy, any previous treatment for the condition (including injections around the elbow, rehabilitation, or use of orthoses), previous surgical treatment of the elbow, other painful elbow conditions, co-existing upper limb and/or neck pain, prior elbow trauma or arthritic changes, posterior interosseous nerve (PIN) neuropathy, and systemic disorders'}, 'identificationModule': {'nctId': 'NCT06854666', 'acronym': 'LET', 'briefTitle': 'Leukocyte-Poor Platelet-Rich Plasma Reduces Pain Symptoms in the Treatment of the Lateral Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Rehasport Clinic'}, 'officialTitle': 'Clinical and Morphological Evaluation Following Treatment of Lateral Epicondylar Tendinopathy with PRP or L-PRP,saline- Prospective Randomized Double Blinded Controlled Trial', 'orgStudyIdInfo': {'id': 'RSC_JWAL_2024_V1'}, 'secondaryIdInfos': [{'id': 'Secec grant 2017', 'type': 'OTHER_GRANT', 'domain': 'European Society for Surgery of the Shoulder and the Elbow'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standardized PRP Injection', 'description': 'A standardized PRP preparation protocol (without commercial kits) is used, ensuring consistency in platelet concentration.\n\nPreparation Process:\n\nBlood Collection: 30 ml of venous blood drawn from each patient Centrifugation: 7 minutes at 2,054 g using MPV-223e centrifuge Separation: Blood fractionated into erythrocytes, leukocytes, PRP, and platelet-poor plasma PRP Isolation: Pure PRP extracted for injection Injection Procedure: 2 ml of PRP injected into the tendon pain area, with 1 ml retained for laboratory analysis', 'interventionNames': ['Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standardized leukocyte-rich PRP (L-PRP)', 'description': 'A standardized leukocyte-rich PRP (L-PRP) preparation protocol (without commercial kits) is used to ensure consistency in platelet and leukocyte concentrations.\n\nPreparation Process:\n\nBlood Collection: 30 ml of venous blood drawn from each patient Centrifugation: 7 minutes at 2,054 g using MPV-223e centrifuge Separation: Blood fractionated into erythrocytes, leukocytes, PRP, and platelet-poor plasma L-PRP Isolation: Leukocyte-rich PRP extracted for injection Injection Procedure: 2 ml of L-PRP injected into the tendon pain area, with 1 ml retained for laboratory analysis', 'interventionNames': ['Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline Injection (Placebo Control)', 'description': 'A placebo control group receiving a standardized saline injection to evaluate the efficacy of PRP and L-PRP treatments.\n\nProcedure:\n\nInjection of 2 ml of sterile saline into the tendon pain area, following the same protocol as the PRP and L-PRP groups.', 'interventionNames': ['Other: effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)']}], 'interventions': [{'name': 'effectiveness of platelet-rich plasma (PRP) in treating lateral epicondylar tendinopathy (LET)', 'type': 'OTHER', 'description': 'The intervention involves the administration of PRP (platelet-rich plasma), L-PRP (leukocyte-rich platelet-rich plasma), and saline according to a protocol developed for patients with lateral epicondylitis (EPi lat). The intervention includes specific parameters such as centrifugation speed and dual injection to the painful site, which is repeated after one week.\n\nFollowing the procedure, treatment continues with a rehabilitation program, including the use of an orthosis. The orthosis serves as support during the recovery process after the injection. The rehabilitation program and the use of the orthosis aim to improve joint function and reduce pain, supporting tissue healing and regeneration.', 'armGroupLabels': ['Saline Injection (Placebo Control)', 'Standardized PRP Injection', 'Standardized leukocyte-rich PRP (L-PRP)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poznan', 'state': 'Wielkopolska', 'country': 'Poland', 'facility': 'Rehasport', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Joanna Walecka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehasport Clinic'}, {'name': 'Przemyslaw Lubiatowski, MD, Phd,', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rehasport Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rehasport Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}