CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Transcutaneous Electrical Nerve Stimulation (TENS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01194466
NCT01194466N/ACompleted

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. Lee·interventional·Posted Sep 3, 2010·Updated Sep 17, 2019

In Brief

A clinical study evaluating Transcutaneous Electrical Nerve Stimulation (TENS) for Head Cancer and 2 related conditions. Completed, enrolled 41 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 3, 2010
Enrollment StartMay 15, 2011
Primary CompletionAug 14, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.8 years ago

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS)device

Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).