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临床试验/NCT04130178
NCT04130178已完成不适用

Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study

Sohag University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Change in pain

研究概览

简要总结

Researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 ACR/EULAR criteria with bilateral hand arthritis aged 18 or above. Nerve block to the neural bundle of the 2nd and 3rd PIPs will be done to one hand (the dominant in half of the participants and the non-dominant in the remaining). The other hand will be used as a control and injected subcutaneously with saline. Half ml of Bupivacaine will be injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP. The needle will be directed alternatively toward the two pedicles on both sides.

PIPs of the 2nd and 3rd fingers in both hands will be examined EULAR-OMERACT scoring system at 0, 2 weeks, and 2 months intervals. Visual analog scale (VAS) for each hand will be used at the same intervals. There are no certain conditions for medications and all the patients were using sDMARDS.

详细描述

PIPs of the 2nd and 3rd fingers at the control group will be injected with .5 mL of saline on each joint through a 27G needle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rheumatoid arthritis patient according to ACR/EULAR criteria
  • bilateral hand affection

排除标准

  • peripheral neuropathy
  • other chronic arthritis
  • patient who did mastectomy or any other hand operation

研究组 & 干预措施

Bupivacine injected

Active Comparator

Half ml of Bupivicaine hydrochloride .5% (Marcaine, Pfizer) was injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP on each side of the selected joint.

干预措施: Nerve block (Drug)

Control group

Placebo Comparator

Saline was injected subcutaneously in the 2nd and 3rd PIP on each side of the selected joint.

干预措施: Saline injection (Drug)

结局指标

主要结局

Change in pain

时间窗: 0 time after 2 weeks and after 2 months

by visual analogue sclae

Change in the degree of inflammation

时间窗: at 0 time after 2 weeks and after 2 months

Musculoskeletal ultrasound evaluation by EULAR-OMERACT score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mahrous

Associate professor

Sohag University

研究点 (1)

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