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临床试验/NCT01194466
NCT01194466已完成不适用

The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial

Jennifer E. Lee2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2011年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
2
主要终点
Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)

研究概览

简要总结

The overall goal of this study is to examine the effect of a single dose of TENS on mucositis pain and function secondary to head and neck radiation therapies. Oral mucositis is an extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth, nose, and throat) that causes significant pain, functional impairment, and diminished quality of life. Head and neck cancers pose specific challenges to effective pain management and past studies suggest the use of effective non-pharmacologic strategies such as TENS may be particularly beneficial for avoiding sources of acute and chronic pain, thereby improving quality of life. The investigators hypothesize that a single dose of TENS will decrease pain and improve function and quality of life in head and neck cancer patients. This project is particularly innovative because it is the first known study to examine the efficacy of TENS, an established safe, inexpensive and easy-to-use non-pharmacologic pain management intervention, for treating acute oral mucositis pain. The investigators research translates bench (animal model) science to human subjects using an interdisciplinary approach to pain management. Establishing whether TENS is effective for reducing mucositis pain is a critical first step toward establishing an effective, non-pharmacologic pain relief intervention for mucositis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Head and Neck Cancer Diagnosis
  • Oral mucositis diagnosis

排除标准

  • TENS use ≤ 5 years
  • Pacemaker
  • Pregnancy

研究组 & 干预措施

Active TENS

Active Comparator

Active high frequency TENS will be use for Active TENS.

干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)

Placebo (low intensity) TENS

Experimental

Placebo TENS will be applied for one arm of the study

干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)

No Treatment

Sham Comparator

TENS unit in place but not turned on

干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)

结局指标

主要结局

Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)

时间窗: The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions

Participants rated 0-10 pain intensity in head/neck cancer area using one number (where their disease was located) by a vertical line on a horizontal 10-cm visual analog scale (VAS) from 0 "no pain" to 10 "worst possible pain." Possible scores ranged from 0-10 (10=worse pain). VAS was assessed two times each visit: (1) Pre-VAS: start of visit, (2) Post-VAS: end of the visit. The outcome measure was each person's change in pain: Pre-VAS minus Post-VAS, to create VAS change score. An average of all participants' VAS change score was calculated for each TENS condition (Active, Placebo, No TENS) and used as the dependent measure.

次要结局

未报告次要终点

研究者

发起方
Jennifer E. Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jennifer E. Lee

Post Doctoral Research Fellow

University of Iowa

研究点 (2)

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