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临床试验/NCT03438864
NCT03438864已完成不适用

Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture

Ege University0 个研究点目标入组 105 人开始时间: 2017年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
主要终点
Volumetry

研究概览

简要总结

Interferential current is a form of electrotherapy that is obtained by placing two different plates that produce medium frequency waveform current, resulting in a low frequency interferential waveform in deeper tissues. It was shown interferential current electrotherapy is beneficial for reduction of traumatic edema in tissues and pain control.

Patients with conservatively managed distal radius fractures were recruited after casts are shed, and were treated with one session(30 minutes) of different protocols of interferential current electrotherapy. Before and after therapy, they were evaluated with volumetry, hand grip strength and visual analogue scale for pain.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Conservatively managed distal radius fractures

排除标准

  • Secondary conditions associated with edema(renal failure, congestive heart failure etc)
  • Complex regional pain syndrome
  • Compartment syndrome
  • Contraindications for electrotherapy(cardiac pacemaker, thrombosis, pregnancy etc)
  • Mental state unfit for electrotherapy
  • Having treated with electrotherapy before

研究组 & 干预措施

10 Hz

Experimental

Interferential current, entry frequency 4000 Hz and 4010 Hz, beat frequency 10 Hz, amplitude was individualized and increased until patients felt a comfortable tickling sensation.

干预措施: Electrotherapy, interferential current (Device)

100 Hz

Experimental

Interferential current, entry frequency 4000 Hz and 4100 Hz, beat frequency 100 Hz, amplitude was individualized and increased until patients felt a comfortable tickling sensation.

干预措施: Electrotherapy, interferential current (Device)

Placebo-Sham Control

Sham Comparator

No current except for first 5 seconds, device open but does not appy electrotherapy.

干预措施: Control (Other)

结局指标

主要结局

Volumetry

时间窗: 30 minutes

Patients were asked to dip their hands slowly into a special bucket full of water with volume markings until their middle finger touched to the bottom of the bucket. The spilled amount of water were measured as milliliters.

Visual Analogue Scale

时间窗: 30 minutes

Patients were asked to express their discomfort level from pain in a scale ranging from 1 to 10(with the help of a 10 cm line), and point they showed were measured as millimeters.

Hand Grip Strength

时间窗: 30 minutes

Patients were asked to use a hydraulic hand dynamometer for hand grip strength in a position of 10 to 30 degrees of wrist extension, and results were registered as kilograms.

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

Funda Atamaz Calis

Professor in Department of Physical Medicine and Rehabilitation

Ege University

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