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临床试验/CTRI/2025/12/099278
CTRI/2025/12/099278尚未招募2 期

Effectiveness of ultrasound guided intra-articular injection of platelet-rich plasma (PRP) in comparison with methylprednisolone acetate in reducing pain and improving function in hip osteoarthritis: A randomized controlled trial

No Primary Sponsor1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年12月27日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
Pain by VAS score

研究概览

简要总结

Osteoarthritis (OA) of hip is a chronic disease with loss of articular cartilage resulting in pain, stiffness and dysfunction of joint affecting day to day activities. It is the 2nd largest joint that is commonly affected by OA. The prevalence of hip OA increases with age and weight. Various treatment modalities of hip OA includes lifestyle modification, exercise, physical therapy, pharmacological treatment such as NSAIDs, intra-articular injection and surgery in advance conditions. Intra-articular steroid injection in hip is commonly practiced. But these treatments are not very effective in preventing the destructive process nor in facilitating reconstruction. Therefore, one of the recent interventions that has gained popularity towards biological treatment is platelet-rich plasma in hip OA. PRP is a biological treatment with great prospective but there is lacking of standardization on the effect of intra-articular PRP injection for the management of hip OA. Due to the limited number of studies available for intra-articular PRP in the management of hip OA, there is still need to study effects of PRP in the management of hip OA. Thus, a randomized controlled trial shall be conducted in the Department of Physical Medicine and Rehabilitation, RIMS, Imphal to determine the effectiveness of ultrasound guided intra-articular injection of PRP in comparison with methylprednisolone acetate in reducing pain and improving function in hip osteoarthritis. The outcome variables which are VAS and WOMAC will be measured before starting intervention at baseline and at 1st week, 4th week, 12th week, 24th week post intervention follow up by using VAS for pain scale and WOMAC for quality of life. To represent the descriptive statistics, mean, standard deviation and percentage will be used. For comparing categorical data, chi square test will be used. Independent t-test will be used for comparison between the groups and the mean changes from baseline within each group will be compared by repeated measures ANOVA test. A p-value < 0.05 will be considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients fulfilling 1991 American College of Rheumatology criteria for hip osteoarthritis
  • Duration of symptoms of more than 3 months
  • KL Grade 2 and 3
  • Age group 40 to 70 years
  • People who are willing to comply with the study and follow up assessments.

排除标准

  • Infection of hip joint
  • Platelet count less than 180×1000/microliter
  • Acute and chronic systemic infections 4.Coagulopathy and Bleeding disorders
  • Impaired cognition
  • Immunosuppressed patients (eg., HIV)
  • Systemic disorders such as uncontrolled diabetes
  • Malignancy.

结局指标

主要结局

Pain by VAS score

时间窗: Baseline, 1 week, 4 week, 12 week and 24 weeks

次要结局

  • Physical function by WOMAC score(Baseline, 1 week, 4 week, 12 week and 24 weeks)

研究者

发起方
No Primary Sponsor
申办方类型
Other [Not applicable]
责任方
Principal Investigator
主要研究者

Bidyabati Yumnam

Regional Institute of Medical Sciences, Imphal, Manipur

研究点 (1)

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