Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Head Cancer, Neck Cancer, Pain

Intervention / Treatment
-----------------
* Device: Transcutaneous Electrical Nerve Stimulation (TENS)


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active TENS<br>Active high frequency TENS will be use for Active TENS. | Device: Transcutaneous Electrical Nerve Stimulation (TENS)<br>* 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).<br>* Other names: EMPI Select;|
| Experimental: Placebo (low intensity) TENS<br>Placebo TENS will be applied for one arm of the study | Device: Transcutaneous Electrical Nerve Stimulation (TENS)<br>* 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).<br>* Other names: EMPI Select;|
| Sham Comparator: No Treatment<br>TENS unit in place but not turned on | Device: Transcutaneous Electrical Nerve Stimulation (TENS)<br>* 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).<br>* Other names: EMPI Select;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS) | 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. | The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Head and Neck Cancer, Oral Cancer, Laryngeal Cancer, Oropharyngeal Cancer, Transcutaneous Electrical Nerve Stimulation (TENS), Oral Mucositis, Function, TENS, Functional Pain, Non-pharamcologic, Quality of Life