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临床试验/NCT05467501
NCT05467501Unknown不适用

Principal Investigator

Eslam Elsayed Ali Shohda0 个研究点目标入组 40 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
pain intensity

研究概览

简要总结

to determine the effect of US on pain intensity in TF patients 2) to determine the effect of US on number of daily finger triggering in TF patients.

详细描述

Trigger finger (T.F) is a disorder characterized by snapping or locking of a finger. Painful popping or clicking sound is elicited by flexion and extension of the involved digit . It is a multifactorial disease. The common mechanism of triggering is that there is a mismatch of diameter between flexors tendons and the annular pulley (retinacular sheath) of the finger. Some studies found inflammatory cells as a part of the pathology, hence anti-inflammatory drugs are the first line of treatment .

Therapeutic ultrasound (US) is a form of acoustic energy which is often used in physical therapy. When US enters the body, it can affect the cells and tissues through thermal and non-thermal mechanisms. While a thermal mechanism has a direct heating effect which promotes anti-inflammatory response with increase blood flow, evidence indicates, however, that non thermal mechanisms are thought to play a primary role in producing a therapeutically significant biological effect (i.e. the stimulation of tissue regeneration) . So my question is in T.F patients does therapeutic ultrasound decrease pain more than anti-inflammatory drugs?

研究设计

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

盲法说明

Patients will not know the actual ultrasound application

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •1 - patients will be included to this study if they are trigger finger patients ( clinically evaluated and refereed by orthopedist).

排除标准

  • •1 - complete locked finger. 2-Ages below 18 y. 3-Patients with any other hand pathology .

研究组 & 干预措施

Ultrasound group

Experimental

Therapeutic ultrasound application. US parameters are 0.8 W/cm for intensity, 3 MHz for frequency and 5 min application. The device that will be used is medserve, England (the head of the device is 5cm). The physical therapy will by 6 sessions (every day). PT sessions will be done by the same physical therapist.

干预措施: Theraputic ultrasound (Device)

placepo group

Active Comparator

group B will have a non-steroidal anti-inflammatory drug as prescribed by the same orthopedist and 2 session of massage with the head of ultrasound.

干预措施: Theraputic ultrasound (Device)

结局指标

主要结局

pain intensity

时间窗: 6 month - 1 year

measured by visual analog scale

次要结局

  • number of daily finger triggering(6 month - 1 year)

研究者

发起方
Eslam Elsayed Ali Shohda
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Eslam Elsayed Ali Shohda

Dr

General Committee of Teaching Hospitals and Institutes, Egypt

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