Exploring the Effectiveness of Combined High Frequency Intensive Autologous Platelet Rich Plasma Injection and Genicular Nerve Blocks in Treating Patients With Moderate to Severe Degrees of Knee Osteoarthritis
Autologous platelet rich plasma and 5% dextrose solution injections.
Arthrite+3
+ Maladies des Articulations
+ Maladies musculo-squelettiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 2019
Date à laquelle le premier participant a commencé l'étude.Our previous study has documented that knee IA PRP injection combined with PRP injection to the pes anserine complex offered better treatment effectiveness as compared with IA PRP alone. In this two-year study, patients with moderate to severe degrees of knee OA will be recruited and divided into 3 groups. The high frequency PRP injection method will be applied (weekly PRP injections for a total of 3 weeks). Group 1 will receive knee IA PRP injections only. Group 2 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex. Group 3 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex, as well as to the genicular nerve blocks using 5% dextrose solution. We hypothesize that patients in group 3 will have better treatment outcomes. The effectiveness will be examined using proteomics, isokinetic measurements and functional scale evaluations. Upon the completion of this study, we will be able to gather adequate scientific evidences as to which injection approach and what PRP injection frequency is a better option in treating patients with moderate to severe degrees of knee OA.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.36 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 45 à 85 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: 1. Patients suffered from chronic unilateral knee pain for more than 4 months and with roentgenogram degenerative findings of grades 3 and 4 on the Kellgren-Lawrence Classification of Osteoarthritis scale (meaning moderate to severe degrees of knee OA) will be recruited. 2. The volume of the SF in the supra-patellar bursa region is enough (at least 2 mm thickness in bursa fluid as measured by ultrasound) to be aspirated via ultrasound guidance. 3. Small volume of SF will be aspirated first and sent for SF analysis. SF showing evidences of crystals suggesting possible gouty arthritis and infection will not be included in this study. 4. Patient has previously received oral NSAIDs and physical modality treatments but WITHOUT any obvious improvements in knee pain and function. The usage of musculoskeletal ultrasound to confirm that the supra-patellar bursa is in communication with the synovial cavity of the knee joint. This is to prevent the aspiration of isolated cystic lesion at the supra-patellar region. Exclusion Criteria: 1. Total obliteration of knee joint as shown on the roentgenogram images. Patient has systemic disorders such as diabetes, rheumatoid arthritis, major axial deviation of the knee joint (varus \>5°, valgus \>5°), hematological diseases (coagulopathy), severe cardiovascular diseases, infections, and immune-depression. 2. Patients in therapy with anticoagulants, and taking NSAIDs within the 5 days before blood harvest 3. Patients with hemoglobin value of less than 11 g/dl, and platelet counts of less than 150,000/mm3.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Chang Gung Memorial Hospital
Taoyuan District, TaiwanOuvrir Chang Gung Memorial Hospital dans Google Maps