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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194466
First Posted: September 3, 2010
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer E. Lee, University of Iowa
  Purpose
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.

Condition Intervention
Head Cancer Neck Cancer Pain Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jennifer E. Lee, University of Iowa:

Primary Outcome Measures:
  • 10cm Visual Analog Scale (VAS) [ Time Frame: 3 weeks ]
    Pain intensity will be assessed at baseline (head and neck regions), immediately after each of the function tasks, and at the end of the testing session for both the head and neck locations.


Secondary Outcome Measures:
  • Pain Pressure Threshold [ Time Frame: 3 weeks ]
    A digital pressure Algometer (Somedic AB, Farsta, Sweden) will be used to measure pain threshold to deep mechanical stimuli.

  • Cutaneous Pain Intensities (CPI's; von Frey filament) [ Time Frame: 3 weeks ]
    CPI's will be performed over the TMJ muscle masseter (i.e., cheek) on both sides of the face (2 CPI application sites), and two times at each site (total of 4 CPI scores). Patients will report the pain intensity of the stimulus using the 10cm VAS scale.


Enrollment: 42
Actual Study Start Date: June 15, 2011
Study Completion Date: August 14, 2012
Primary Completion Date: August 14, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active TENS
Active high frequency TENS will be use for Active TENS.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
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).
Other Name: EMPI Select
Experimental: Low Intensity TENS
Low Intensity TENS will be applied for one arm of the study
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
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).
Other Name: EMPI Select
Sham Comparator: No Treatment
TENS unit in place but not turned on
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
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).
Other Name: EMPI Select

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Head and Neck Cancer Diagnosis
  • Oral mucositis diagnosis

Exclusion Criteria:

  • TENS use ≤ 5 years
  • Pacemaker
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194466


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Jennifer E Lee, PhD University of Iowa
  More Information

Responsible Party: Jennifer E. Lee, Post Doctoral Research Fellow, University of Iowa
ClinicalTrials.gov Identifier: NCT01194466     History of Changes
Other Study ID Numbers: University of Iowa 2031062
First Submitted: September 1, 2010
First Posted: September 3, 2010
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer E. Lee, University of Iowa:
Head and Neck Cancer
Oral Cancer
Laryngeal Cancer
Oropharyngeal Cancer
Transcutaneous Electrical Nerve Stimulation (TENS)
Oral Mucositis
Pain
Function
TENS
Functional Pain
Non-pharamcologic
Quality of Life

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms