跳至主要内容
临床试验/NCT02012686
NCT02012686已完成不适用

The Effect of Transcutaneous Electrical Nerve Stimulation for Reduction of Posterior Neck Pain After Thyroidectomy

Yonsei University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2013年11月最近更新:
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
100
试验地点
2
主要终点
Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy

研究概览

简要总结

The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after thyroidectomy.

详细描述

Thyroidectomy is performed in supine position with the neck fully extended. After thyroidectomy, 80 percent of patients experience posterior neck pain as well as the incision site pain. The posterior neck pain is thought to be due to hyperextension is continued during an average of 90 minutes of surgery. Non-steroidal anti-inflammatory agents or opioids are administrated to reduce the pain, but the pain still remained.

TENS is simple, non-invasive analgesic technique that is used extensively to reduce acute and chronic pain. TENS has beneficial effect for the reduction of postoperative pain. The conventional way of administering TENS is to use electric characteristics that selectively activate large diameter Aβ fiber mediating touch perception without activating smaller diameter Aδ and C fiber.

In this study, TENS during thyroidectomy in posterior neck pain will be evaluated.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergoing open total thyroidectomy under general anesthesia
  • American Society of Anesthesiology physical status I or II

排除标准

  • American Society of Anesthesiology physical status III or IV
  • History of headache or neck pain within six months
  • Past history of herniated cervical disc, cervical foraminal stenosis, ossification of posterior longitudinal ligament

研究组 & 干预措施

Control group

Placebo Comparator

numerical rating scale of TENS non-applied group

TENS group

Active Comparator

numerical rating scale of TENS applied group

干预措施: TENS (Device)

结局指标

主要结局

Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy

时间窗: 0.5 hours after thyroidectomy

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy

时间窗: 48 hours after thyroidectomy

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy

时间窗: 6 hours after thyroidectomy

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy

时间窗: 24 hours after thyroidectomy

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

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

Cholhee Park

clinical assisted professor

Yonsei University

研究点 (2)

Loading locations...

相似试验

The Effect of Transcutaneous Electrical Nerve... | 临床试验