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临床试验/NCT06131996
NCT06131996已完成不适用

Comparison of the Effects of Volar-assisted and Elastic Wrist Splints on Edema, Pain, Grip Strength and Functionality in Pregnant Women With Carpal Tunnel Syndrome

Mardin Artuklu University2 个研究点 分布在 2 个国家目标入组 41 人开始时间: 2022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
41
试验地点
2
主要终点
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)

研究概览

简要总结

It is aimed to compare the effect of two different splints on carpal tunnel syndrome in pregnant individuals after 4 weeks of use.

详细描述

Carpal tunnel syndrome (CTS) is a common musculoskeletal problem in pregnancy. The aim of this study is to compare the effects of rigid and elastic wrist splints on edema, pain levels, grip strength, and upper extremity functionality in pregnant women with CTS.

Pregnant women in the last trimester of pregnancy who were diagnosed with CTS were included in the study.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Being in the last trimester of pregnancy,
  • Having a diagnosis of CTS,
  • Positive Tinnel and Phalen tests,
  • Pain, tenderness, and numbness symptoms in the median nerve neurodynamic test,
  • pain of at least 4 severity according to VAS,
  • Edema due to pregnancy

排除标准

  • Individuals in the 1st or 2nd trimester of pregnancy,
  • Those with pain complaints below 4 according to VAS,
  • Those with a history of CTS before pregnancy,
  • Those who had undergone surgery in the hand-wrist region
  • Those diagnosed with cervical disc herniation

结局指标

主要结局

Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)

时间窗: before intervention and 4 weeks after intervention

Q-DASH questionnaire is applied to evaluate upper extremity-related functionality and symptoms. Each item provides 5 response options and the overall score is calculated from the item scores. 0, no loss of function; 100 is interpreted as the most severe loss of function.

The Boston Questionnaire (BA)

时间窗: before intervention and 4 weeks after intervention

The Boston Questionnaire (BA) is specific to Carpal Tunnel Syndrome (CTS) and consists of two different scales that evaluate symptom severity and functional capacity.The scoring of each item varies between 1 and 5. The average score is obtained by dividing the total score by the number of items and ranges from 1 to 5. A high score indicates low functional capacity. Mean scores are calculated separately for symptom severity and functional capacity. The symptom score consists of 11 items and the function score consists of 8 items.

Grip strength

时间窗: before intervention and 4 weeks after intervention

Grip strength was measured with the Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and whose validity and reliability have been confirmed in many studies.According to the measurement procedure, three repeated measurements were made for hand grip strength and the results were recorded in kilograms.

Volumetric measurement

时间窗: before intervention and 4 weeks after intervention

The water flooding method, which is considered the gold standard in the measurement of extremity volume and is preferred in the evaluation of edematous hand or foot volume, was used in this study.With this measurement method, the amount of overflowing water volume between the affected and unaffected extremities was compared and the amount of edema was determined.

Visual Analog Scale (VAS)

时间窗: before intervention and 4 weeks after intervention

The pain levels were measured by the Visual Analog Scale (VAS).It is scored between 0-10 cm. A high score indicates high pain.

次要结局

未报告次要终点

研究者

发起方
Mardin Artuklu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Funda Mete Cavus

Principal Investigator

Mardin Artuklu University

研究点 (2)

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