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临床试验/CTRI/2024/01/061287
CTRI/2024/01/061287招募中4 期

Comparison of Intra-articular corticosteroids with and without intra articular local anesthesia in patients with chronic inflammatory arthritis: a randomised control trail with paired-design.

Department of Internal MEdicine1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月15日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
80
试验地点
1
主要终点
Improvement in joint-pain

研究概览

简要总结

Joint Injections of corticosteroid are routinely practised in patients with inflammatory arthritis like rheumatoid arthritis and spondyloarthritis. Routinely inflamed joints like shoulders, kinees, ankles and elbows are done. These lead to rapid relef. However, just after giving the injection it takes times for the corticosteroid to act, and sometimes it may also cause an increase in joint pain for a few days due to steroid crystals leading to inflammation. Addition of lignocaine, which is a local anaesthetic agent to the corticosteroid being injected into the joint is practised at some centers. The logic of this addition is its ability to lead to rapid improvement (within minutes) and also the prevention of joint flares. However, this has not been investigated by a trail

We propose to compare whether the addition of the local anaesthetic agent mixed to the corticosteroid before giving the joint injection will benefit the short and medium term improvement which the patient feels with this intervention and whether there is any difference in the remission rates over a longer term of 3-months. We plan a paired-design, that is we will include only those patients whose paired joints have to be injected and then inject one of these joints with corticosteroid alone and one with addition oflignocaine to the corticosteroid. This paired design will standardise the pain felt by each patient and lead to a better and easier comparison of which arm is doing better.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed as a case of rheumatoid arthritis or spondyloarthritis
  • Having bilateral symmetrical swollen joints.
  • either both shoulders or knees or ankles or elbows planned for joint injections.

排除标准

  • Patient refusal to participate in study
  • Allergy to Lignocaine or Methyl-Prednisolone acetate
  • Joints are damaged
  • Inability of the patient to be able to understand or give pain scores
  • Non-symmetrical joint involvement (Symmetry as assessed by physician)
  • Standard exclusion for any intra-articular steroids including Septic-arthritis or overlying skin infection,Coagulopathy, Joint Prosthesis, Intra-articular fracture.

结局指标

主要结局

Improvement in joint-pain

时间窗: 1-hour

次要结局

  • Procedural pain between the IAC+LA versus IAC alone(immediate)
  • Improvement in Joint-pain at 1-day between the IAC+LA versus IAC alone(1 day)
  • Improvement in Joint-pain at 1-week between the IAC+LA versus IAC alone(1 week)
  • Relapse rates at 3 months post intra articular injection(3 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Varun Dhir

PGIMER, Chandigarh

研究点 (1)

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