N/A
N=41
Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)
Head Cancer · Neck Cancer · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01194466 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS) — -1.4; -0.6; 0.1 change units on a VAS scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jennifer E. Lee
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS) |
-1.4; -0.6; 0.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Head and Neck Cancer Diagnosis
- Oral mucositis diagnosis
Exclusion Criteria
- TENS use ≤ 5 years
- Pacemaker
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01194466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.