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Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial.

ABSTRACT: Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of platelet-rich plasma (PRP) in painful tendons is widespread but its efficacy remains controversial.This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have ultrasound (US)-guided needling combined with a leukocyte-depleted (that is, pure) PRP or lidocaine each alternate week for a total of two interventions. Outcome data will be collected before intervention, and at 6 weeks, 3, 6, and 12 months after intervention.Changes in pain and activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH-E, Spanish version) score, at 6 months. We will compare the percentage of patients in each group that achieve a successful treatment defined as a reduction of at least 25% in the DASH-E score. Secondary outcome measures include changes in DASH-E at 3 and 12 months, changes in pain as assessed by the visual analogue scale (VAS) at the 6-week, 3-, 6-, and 12-month follow-up, changes in sonographic features and neovascularity, and percentage of patients in each group with adverse reactions at 3, 6, and 12 months.The results of this study will provide insights into the effect of pure PRP in tendon and may contribute to identifying the best protocol for PRP application in tendinopathies.ClinicalTrials.gov: NCT01945528.

SUBMITTER: Martin JI

PROVIDER: S-EPMC4220815 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial.

Martin Jose I JI Merino Josu J Atilano Leire L Areizaga Luis M LM Gomez-Fernandez Maria C MC Burgos-Alonso Natalia N Andia Isabel I

Trials 20131201

<h4>Background</h4>Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of platelet-rich plasma (PRP) in painful tendons is widespread but its efficacy remains controversial.<h4>Methods/design</h4>This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have ultrasound (US)-guided needling combined with a leukocyte-depleted (that is, pure) PRP or lidocaine each alternate wee ...[more]

PMID: 24289799

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Project description:BackgroundKnee osteoarthritis (OA) is a common, chronic, progressive and degenerative disease which affects patients' quality of life and may cause disability and social isolation. OA is a huge economic burden for the patient and a large strain for the whole healthcare system. Articular cartilage has a small potential to repair, with progressively more clinicians emphasizing cellular therapy. Subcutaneous fat tissue in human body is a large reservoir of mesenchymal stem cells (MSCs) and is been harvested in minimally invasive, simple procedure. Up to date there is no prospective randomized controlled studies demonstrating effectiveness and role of adipose tissue injections in OA treatment. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or platelet rich plasma (PRP) and to compare efficacy of both therapeutic methods.MethodsThis is a prospective, randomized, controlled study. Patients who meet inclusion criteria will be allocated to Fat Tissue group or PRP group randomly. Subjects will receive an intra articular injection with autologous adipose tissue and PRP respectively. Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The assessment consists of patient reported outcome measures (The Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000, the Western Ontario and McMaster Universities Osteoarthritis Index, the Health Questionnaire EQ- 5D- 5 L), three functional tests (The Timed Up and Go Test, The 5 Times Sit to Stand Test, The 10 m Walk Test) and Maximal Isometric Voluntary Contraction.DiscussionThis study protocol has several strengths and weaknesses. One of strongest point of this study is the wide, multidimensional functional assessment which will give a large amount of objective data. On the other hand, lack of blinding has to be considered as a risk of both subject and investigator bias.Trial registrationname of registry: ClinicalTrials.gov, trial registration number: NCT04321629, retrospectively registered on date of registration.

Project description:BackgroundIntraarticular plasma-rich platelet (PRP) and hyaluronic acid (HA) have each been shown to be effective for treating knee osteoarthritis (OA). Evidence supporting the combination therapy is controversial. This study aimed to investigate the efficacy of a single intraarticular PRP injection combined with different HAs in patients with knee OA.MethodsIn this prospective randomized-controlled trial, 99 patients with Kellgren-Lawrence grade 2 knee OA with average knee pain ≥ 30 mm on a 0-100 mm pain visual analog scale (VAS) were randomized into two groups. The PRP + Artz group received a single intraarticular HA (Artz, 2.5 ml, 10 mg/ml) followed by 3 ml PRP (n = 50). The PRP + HYAJOINT Plus group received a single intraarticular cross-linked HA (HYAJOINT Plus, 3 ml, 20 mg/ml) followed by 3 ml PRP (n = 49). All patients were evaluated before and at 1, 3 and 6 months after injections. The primary outcome was the VAS pain reduction from baseline at 6 months. Secondary outcome measures included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, single leg stance (SLS) test and patient satisfaction.ResultsNinety-five patients were analyzed by intention-to-treat analysis. Both groups improved significantly in VAS pain, WOMAC, Lequesne index and SLS at 1, 3 and 6 months post intervention (p < 0.05). Between-group comparisons showed no significant differences at most follow-up time points, except better improvements in Lequesne index at 1 month (p = 0.003) and WOMAC-stiffness score at 6 months (p = 0.020) in the PRP + Artz group, and superiority in SLS at 1, 3 and 6 months in the PRP+ HYAJOINT Plus group (p < 0.001, p = 0.003 and p = 0.004). Additional Johnson-Neyman analyses showed that among the patients with baseline WOMAC-pain score > 8.5, WOMAC-function score > 21.7 and WOMAC-total score > 32.0, respectively, those treated with PRP + HYAJOINT Plus injections had better effects in WOMAC-pain, WOMAC-function and WOMAC-total scores than those treated with PRP + Artz at 3 months postinjection (p < 0.05). Both groups reported high satisfaction. No serious adverse events occurred during the study.ConclusionsA single PRP injection combined with Artz or HYAJOINT Plus is effective and safe for 6 months in patients with knee OA. Both injection regimens are potential treatment options for knee OA. Further studies are needed to confirm these results.Trial registrationThe study was registered at ClinicalTrials.gov (NCT04931719), retrospectively. Date of registration 18/6/2021.Name of trial registryComparing efficacy of single PRP combined with different hyaluronans for knee osteoarthritis.Level of evidenceTherapeutic Level 1.

Project description:BackgroundPost-traumatic headaches (PTH) are a common sequelae of traumatic brain injury (TBI) and greatly impact patient function and quality of life. Post-traumatic greater occipital neuralgia (GON) is a type of post-traumatic headache. Conventional treatment includes steroid/anesthetic injections which typically alleviate pain but have a short duration of effect. Platelet-rich plasma (PRP) is an emerging biological treatment for numerous degenerative disorders, including peripheral nerve disorders. The primary aim of this pilot study is to evaluate whether a randomized control trial of PRP for the treatment of GON in patients with post-traumatic headaches is feasible in regard to recruitment, adherence, retention, and adherence and adverse events. Exploratory aims include improvement in pain, function, and quality of life in patients with post-traumatic GON receiving PRP compared to steroid/anesthetic and normal saline injections.MethodsThirty adults (over 18 years of age) with post-traumatic GON will be randomized into one of three groups: (1) autologous PRP injection, (2) steroid/anesthetic injection (standard care), or (3) placebo injection with normal saline. Injections will be performed to the greater occipital nerve under ultrasound guidance by a trained physician. Daily headache intensity and frequency data will be collected pre-injection and for the duration of the study period. Feasibility will be defined as greater than 30% recruitment, 70% completion of intervention, 70% retention, and less than 2 minor adverse events. Exploratory outcomes will be explored using the Headache Impact Test-6 (HIT-6, a valid and reliable 6-item questionnaire for assessment of the impact of headaches across different diagnostic groups of headaches) and the quality of life in following brain injury questionnaire (QOILIBRI).DiscussionThis pilot study will be the first to evaluate the feasibility of PRP as a potential treatment of GON in patients with post-traumatic headache.Trial registrationClinicalTrials.gov - NCT04051203 (registered August 9, 2019).

Project description:BACKGROUND:Achilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients during the lengthy healing period. Current treatment strategies struggle to curb the burden of this injury on health systems and society due to lengthy rehabilitation, work absence and reinjury risk. Platelet-rich plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies. The use of PRP in musculoskeletal injuries is on the increase despite the lack of adequately powered clinical studies. METHODS AND DESIGN:This is a multicentre randomised controlled trial to evaluate the efficacy and mechanism of PRP in patients with acute Achilles tendon rupture (ATR). All adults with acute ATR presenting within 12 days of the injury who are to be treated non-operatively are eligible. A total of 230 consenting patients will be randomly allocated via a remote web-based service to receive PRP injection or placebo injection to the site of the injury. All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce efficacy interference.Participants will be followed up with blinded assessments of muscle-tendon function, quality of life, pain and overall patient's functional goals at 4, 7, 13, 24 weeks and 24 months post-treatment. The primary outcome is the heel-rise endurance test (HRET), which will be supervised by a blinded assessor at 24 weeks. A subgroup of 16 participants in one centre will have needle biopsy under ultrasound guidance at 6 weeks. Blood and PRP will be analysed for cell count, platelet activation and growth factor concentrations. ETHICS AND DISSEMINATION:The protocol has been approved by the Oxfordshire Research Ethics Committee (Oxfordshire Research Ethics Committee A, reference no 14/SC/1333). The trial will be reported in accordance with the CONSORT statement and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER:ISRCTN: 54992179, assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.

Dataset Information

Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial.

Publications

Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial.

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