Overview

This trial is active, not recruiting.

Conditions head cancer, neck cancer, pain
Treatment transcutaneous electrical nerve stimulation (tens)
Sponsor University of Iowa
Start date May 2011
End date August 2012
Trial size 50 participants
Trial identifier NCT01194466, University of Iowa 2031062

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Active high frequency TENS will be use for Active TENS.
transcutaneous electrical nerve stimulation (tens) EMPI Select
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).
(Experimental)
Low Intensity TENS will be applied for one arm of the study
transcutaneous electrical nerve stimulation (tens) EMPI Select
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).
(Sham Comparator)
TENS unit in place but not turned on
transcutaneous electrical nerve stimulation (tens) EMPI Select
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).

Primary Outcomes

Measure
10cm Visual Analog Scale (VAS)
time frame: 3 weeks

Secondary Outcomes

Measure
Pain Pressure Threshold
time frame: 3 weeks
Cutaneous Pain Intensities (CPI's; von Frey filament)
time frame: 3 weeks

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - Head and Neck Cancer Diagnosis - Oral mucositis diagnosis Exclusion Criteria: - TENS use ≤ 5 years - Pacemaker - Pregnancy

Additional Information

Official title The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial
Principal investigator Jennifer E Lee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Iowa.