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临床试验/NCT04645056
NCT04645056Unknown不适用

The Impact of Post-thyroidectomy Neck Stretching Exercises on Improving Short Term Quality of Life: A Randomized Prospective Clinical Trial

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Short time quality of life (QoL)

研究概览

简要总结

The project deals with patients undergoing surgery in the neck due to benign tumor in the thyroid gland in order to remove pressure symptoms.

The background of the project is a recent series of studies (Sorensen, Watt et al. 2017) (Sorensen, Watt et al. 2017), showing that patients are very adversely affected by a reduced voice function and pain the neck/shoulders in the first weeks and months after the operation. In general, the patients quality of life is impaired in this period. Due to this, it is relevant to seek ways to reduce the discomfort symptoms after the operation by performing simple and specific chosen stretching exercises for the muscles in the neck and shoulders.

The patients in the project are randomly divided into two groups, and both groups are answering questionnaires after 1,2, 4 weeks and after 3 months regarding their short time quality of life focusing on voice function and pain in the neck and shoulders. The patients in the intervention group are instructed in stretching and mobility exercises for neck and shoulder starting the day after surgery and they are supposed to perform them every day in four weeks after surgery. The control group are not performing these exercises and are not informed that there concurrently is an intervention going on. In this way the questionnaires can be compared in the end.

The hypothesis is that short time quality of life including voice function and pain the neck and shoulder can be improved for this group of patients with these specific stretching and mobility exercises. The project is of great clinical relevance and can in case of confirmed hypothesis be applied in clinical practice immediately benefitting the patients undergoing surgery.

详细描述

PROJECT DESCRIPTION

Background/introduction:

Removing all or part of the thyroid gland by surgery, has routinely been used for more than 100 years for the treatment of patients with benign as well as malignant thyroid disease. It is generally accepted that quality of life is improved three-to-six months after surgery (Mishra, Sabaretnam et al. 2013) (Sorensen, Watt et al. 2017) (Watt, Cramon et al. 2014). However, in the days and weeks following thyroid surgery, patients often experience muscle pain and stiffness of the neck and shoulders (Yuuki Takumara 2005). In addition, 2-4 weeks postoperatively voice discomfort symptoms can be pronounced, and although short-termed and passing, patients experience a decreased quality of life (Sorensen, Printz et al. 2019) (Vicente, Solomon et al. 2014) (Ryu, Ryu et al. 2013). The accumulation of such symptoms in the weeks just after surgery may reduce quality of live significantly. Therefore, any rehabilitative interventions which may reduce discomfort are highly relevant.

A limited number of randomized trials have investigated the effect of early postoperative rehabilitative measures such as neck stretching. Rehabilitation with stretching exercises is found to reduce neck pain, neck stiffness, and the need for postoperative pain relief medication (Yuuki Takumara 2005) (Hatice Ayhan 2016). No study has examined the effect of neck stretching exercises on short term quality of life improvements in relation to voice function despite many of the neck muscles are used for voice production. The same goes for the impact of neck stretching exercises on short term quality of life improvements in relation to neck pain.

Objective/Purpose The objective is to examine the effect of neck stretching exercises performed shortly after hemi- and total thyroidectomy on short term quality of life in relation to subjective voice function and neck pain in the first four weeks after surgery.

研究设计

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

入排标准

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

入选标准

  • •Patients undergoing either hemi- or total thyroidectomy for a benign thyroid disease

排除标准

  • •Pre-operative recurrent laryngeal nerve palsy
  • •Pre-operative voice disorder requiring treatment by surgery or speech language pathology
  • •Previous neck surgery including thyroid surgery
  • •Patients under the age of 18 years old

研究组 & 干预措施

Intervention group

Experimental

a. Intervention Group: Neck stretching and movement

The patient starts the stretching exercises the morning after surgery with instructions from a trained professional at the department. The patient is informed that the stretching exercises will not affect the surgical wound. The patient is instructed in performing five repetitions of each of the following nine exercises three times each day in four weeks:

  1. Relax shoulders and neck sufficiently
  2. Look down - Stretching and movement
  3. Look to each side - movement
  4. Lower the head to each side - stretching
  5. Lower the head diagonally to each side - stretching
  6. Small nod movements
  7. Lift the shoulders - movement
  8. Roll the shoulders - movement
  9. Lift the arms - movement

The first stretching session is observed by the instructor who gives feedback and correct the exercises, if necessary. Furthermore, the patient is given a training brochure.

干预措施: Stretching and Mobility exercises for neck and shoulder (Other)

Control group

No Intervention

b. Control group The patients in the control group are not instructed in any intervention but are answering completely similar questionnaires as the intervention group.

结局指标

主要结局

Short time quality of life (QoL)

时间窗: Short time QoL three months after surgery

Short time quality of life including voice quality and pain in neck and shoulders measured in specific questionnaires answered before and 4 times after surgery (2 weeks before, 1,2,4 weeks and 3 months after surgery).

Short time quality of life (QoL)

时间窗: Short time QoL 1 week after surgery

Short time quality of life including voice quality and pain in neck and shoulders measured in specific questionnaires answered before and 4 times after surgery (2 weeks before, 1,2,4 weeks and 3 months after surgery).

Short time quality of life (QoL)

时间窗: Short time QoL 2 weeks after surgery

Short time quality of life including voice quality and pain in neck and shoulders measured in specific questionnaires answered before and 4 times after surgery (2 weeks before, 1,2,4 weeks and 3 months after surgery).

Short time quality of life (QoL)

时间窗: Short time QoL 4 weeks after surgery

Short time quality of life including voice quality and pain in neck and shoulders measured in specific questionnaires answered before and 4 times after surgery (2 weeks before, 1,2,4 weeks and 3 months after surgery).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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