Efficacy Of Intra-Articular Injection Of Platelet Rich Plasma And The Modulation Of mRNA Expression Of MAT2B Gene In Patients With Early Stage Osteoarthritis Knee:A Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1)Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score,
研究概览
简要总结
The present prospective interventional study aims to evaluate the efficacy of intra-articular injection of platelet rich plasma and themodulation of mRNA expression of MAT2B gene in patients with early stage osteoarthritisknee.
Patients of age >45 years and <65 years who are diagnosed case of osteoarthritis knee based on clinico- radiological diagnosis will be included. In case of bilateral symptoms side with more significant symptom receives treatment with NRS score of ≥4/10 over minimum 3 months and Grade 1, 2, 3 of Kellgren and Lawrence system of classification of severity of kneeOA, who have tried atleast 3 months of non-invasive conservative treatmentincluding lifestyle modification before the beginning of therapy. Patients will be excluded if a diagnosis of secondary OA (Post-traumatic, post-surgical and post-inflammatoryosteoarthritis) or history of recent intra-articular injection of corticosteroids within last 3 months or prior treatmentwith hyaluronic acid in past 6 months or Anemia (Hb < 10gm%). Procedure of intra-articular injection of PRP will be conducted under C-armfluoroscopic guidance under full aseptic precautions in the operation theatre. Primary outcome measures are Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score, stiffnessscore, physical function score and total score at various designated intervals
Secondary Outcome measures are NRS pain scores, Lequesne scores, NPSI scores, SF-12 questionnaire. Comparison of modulation in mRNA expression of MAT2B genes at baseline and at the end of 12th week following intra-articular treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age >45 years and <65 years 2)Diagnosed case of osteoarthritis knee based on clinico- radiological diagnosis 3)In case of bilateral symptoms side with more significant symptom receives treatment 4)NRS score of ≥4/10 over minimum 3 months 5)Grade 1, 2, 3 of Kellgren and Lawrence system of classification of severity of knee OA(28) 6)Patients who have tried atleast 3 months of non-invasive conservative treatment including lifestyle modification before the beginning of therapy.
排除标准
- •Diagnosis of secondary OA (Post-traumatic, post-surgical and post-inflammatory osteoarthritis) 2)Recent intra-articular injection of corticosteroids within last 3 months and prior treatment with hyaluronic acid in past 6 months 3)Anemia (Hb < 10gm%).
结局指标
主要结局
1)Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score,
时间窗: baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week
stiffness score, physical function score and WOMAC total score at various designated
时间窗: baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week
intervals
时间窗: baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week
2)NRS pain score at various designated intervals
时间窗: baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week
次要结局
- 1)Lequesne scores following implementation of injection at various designated intervals(2)Neuropathic component of pain using NPSI scores at various designated intervals)