跳至主要内容
临床试验/CTRI/2019/08/020977
CTRI/2019/08/020977尚未招募不适用

A Study to translate and validate self reported shoulder dysfunction scales into Hindi and Marathi in patients of Head and Neck cancers

NA1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年9月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NA
入组人数
70
试验地点
1
主要终点
To translate shoulder dysfunction specific questionnaires namely Constant shoulder scale and Neck Dissection Impairment Index into Hindi and Marathi

研究概览

简要总结

Neck dissection plays an integral part in the surgical management of head and neck cancers. Although neck dissection techniques were described as early as the eighteenth century, a systematic approach to it was described by George Washington Crile in 1906.1 The technique of neck dissection has undergone major transformations over the years, from Radical neck dissection to a Selective neck dissection.2 Neck dissection is a time tested procedure, however it is still associated with significant complications. Injury to the spinal accessory nerve results in the Painful Shoulder Syndrome or the 11th Nerve Syndrome. 3 The incidence of painful shoulder syndrome varies between the various types of neck dissection. It is highest in radical neck dissection (79%) and modified radical neck dissection (65%). 4 A lower incidence of Shoulder dysfunction syndrome has been seen in selective neck dissection. 5 Shoulder dysfunction in Selective neck dissection is primarily due to handling of the spinal accessory and thermal injury due to electrocautery, some authors therefore avoid dissection of Level IIb nodes in clinically N0 neck.5 Various scales such as self-report Flexilevel scale of shoulder

function, constant shoulder score etc., are used to assess shoulder dysfunction in the post-operative period. 6, 7 Electromyography(EMG) is an objective way to evaluate shoulder dysfunction, and it has been shown to be a sensitive and painless method.8 However EMG may not be available at all times and therefore there needs to be an alternative way to detect shoulder dysfunction. NDII and Constant Morley’s scales are widely used to subjectively assess degree of shoulder dysfunction. Constant’s score was devised by Christopher Constant for standardisation of shoulder function assessment, it was revised and modified in 2008. NDII was devised as a health-related quality-of-life (QOL) instrument for patients following neck dissection and to identify the factors that affect QOL following neck dissection in 2002 by Rodney Taylor, it is approved by the American association of Shoulder and elbow surgeons. In this study, we aim to translate the constant shoulder scale and NDII and validate these scales. Early confirmation of shoulder dysfunction would aid to initiate early physical therapy for the patients which would reduce the associated morbidity.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients of head neck cancer who have undergone some form of neck dissection
  • Loco-regionally controlled
  • Age 18-75 years
  • Literate patients – patients who have studied high school and can read, write and understand either Hindi or Marathi.
  • ECOG 0, 1, 2 performance status.

排除标准

  • Age < 18 years or >75 years
  • Illiterate patients
  • ECOG status >2
  • Patients undergoing only level VI neck dissection.

结局指标

主要结局

To translate shoulder dysfunction specific questionnaires namely Constant shoulder scale and Neck Dissection Impairment Index into Hindi and Marathi

时间窗: At the start of the study

次要结局

  • 1. To generate psychometric data regarding the questionnaires’ reliability and validity when used in the Indian population(2. To compare the ease of administration between the two questionnaires i.e. Constant Shoulder Scale and neck dissection Impairment Index.)

研究者

发起方
NA
申办方类型
Other [na]

研究点 (1)

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