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临床试验/NCT04275505
NCT04275505已完成不适用

Efficacy of Shortwave Diathermy in Ulnar Nerve Entrapment on the Elbow

Fatih Sultan Mehmet Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
2
主要终点
pain in hand and elbow due to ulnar nerve entrapment

研究概览

简要总结

It was aimed to see if there is any efficacy of short wave diathermy (SWD) in the treatment of ulnar nerve entrapment at the elbow (UNE). Ulnar nerve entrapment, following carpal tunnel syndrome (CTS), is the second most common upper extremity entrapment neuropathy. Ulnar nerve is compressed mostly in elbow region because of its anatomy. Conservative treatment choices are limited in ulnar nerve entrapment neuropathy and very few studies about UNE, are available in literature.

The aim of this study was researching the efficacy of SWD which is a deep heating modality in treatment of UNE. SWD is used either continuous or pulsed mode. Continuous SWD is used for the purpose of heating.

MATERIALS AND METHODS: 61 adult patients, who had been diagnosed with UNE clinically and electrophysiologically, were randomly assigned into two groups. Ten sessions of SWD was applied to the patients in the treatment group as 5 sessions per week for 2 weeks. Ten sessions of placebo SWD was applied to the patients in the control group as 5 times a week, for 2 weeks. All patients in both groups were given elbow splints and were informed to avoid symptom provocating activities. Patients were evaluated at baseline, at the end of the treatment and,1 and 3 months after the treatment. Besides physical examination, quick-DASH (disabilities of arm, shoulder, hand) and SF-36 were used to evaluate activities of daily life, dynamometer was used to evaluate grip force and VAS was used to evaluate pain severity.

详细描述

efficacy of short wave diathermy in ulnar nerve entrapment on the elbow

ABSTRACT

OBJECTIVE: Efficacy of short wave diathermy (SWD) in the treatment of ulnar nerve entrapment at the elbow (UNE).

MATERIALS AND METHODS: 61 adult patients, who had been diagnosed with UNE clinically and electrophysiologically, were randomly assigned into two groups. Ten sessions of SWD was applied to the patients in the treatment group as 5 sessions per week for 2 weeks. Ten sessions of placebo SWD was applied to the patients in the control group as 5 times a week, for 2 weeks. All patients in both groups were given elbow splints and were informed to avoid symptom provocating activities. Patients were evaluated at baseline, at the end of the treatment and,1 and 3 months after the treatment. Besides physical examination, quick-DASH (disabilities of arm, shoulder, hand) and SF-36 were used to evaluate activities of daily life, dynamometer was used to evaluate grip force and VAS was used to evaluate pain severity.

INTRODUCTION

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)

盲法说明

the participants did not know if they were in tratment group or control group. both of the group participants were asked to put their elbow into the shortwave diathermy device and they did not know if the device was turned on or off.

the investigator (Naciye Bilgin Badur) did not know the participants group while performing physical examination before and after intervention in control visits.

investigator and outcome assessor are the same person who is Naciye Blgin Badur

入排标准

年龄范围
16 Years 至 79 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • UNE Diagnosis Criteria suggested by American Neurology Society (12);
  • Ulnar nerve motor conduction velocity lower than 50 m/sec in elbow region
  • Elbow region ulnar nerve motor conduction velocity 10 m/sec lower than forearm region
  • More than 20% decrease in compound muscle action potential (CMAP) amplitude in above elbow stimulation compared to below elbow
  • Evident difference in configuration of above elbow CMAP compared to below elbow
  • If 2 of the criteria are positive it is a possible UNE diagnosis, and it is certain UNE diagnosis in case 3 criteria are positive.

排除标准

  • cervical radiculopathy
  • brachial plexopathy
  • ulnar nerve cut and trauma
  • sensation deficit in application region
  • diabetes mellitus
  • polyneuropathy
  • wound, burn, scar mark on forearm research region
  • presence of implant, prothesis, pin in tissue
  • not having well general health
  • presence of intrauterine device
  • presence of hearing instrument
  • presence of tumor, inflammatory states
  • pregnancy or suspect of pregnancy
  • being exposed to radiotherapy ( during the last 6 months)

结局指标

主要结局

pain in hand and elbow due to ulnar nerve entrapment

时间窗: 3 months

the pain of the participants were measured with VAS (visiual analogy scale). the difference between pain in baseline and 3 months after treatment were compared in order to get the primary outcome measure

hand function in daily living activities

时间窗: 3 months

the progress in function was measured with quick -DASH questionnaire. the baseline measure and 3 months after treatment measures were compared in order to get the primary outcome measure

次要结局

未报告次要终点

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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