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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jennifer E. Lee, University of Iowa
ClinicalTrials.gov Identifier:
NCT01194466
First received: September 1, 2010
Last updated: January 4, 2012
Last verified: January 2012

September 1, 2010
January 4, 2012
May 2011
June 2012   (final data collection date for primary outcome measure)
10cm Visual Analog Scale (VAS) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01194466 on ClinicalTrials.gov Archive Site
  • Pain Pressure Threshold [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Pain Pressure Threshold [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • The Head and Neck Cancer Inventory (HNCI) [ Time Frame: 3 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]
    The HNCI is a 30-item, five-point Likert questionnaire with items in five domains: eating, speech, aesthetics, pain/discomfort, and social activity; one additional question assesses overall quality of life.
Not Provided
Not Provided
 
Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)
The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Head Cancer
  • Neck Cancer
  • Pain
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
  • Active Comparator: Active TENS
    Active high frequency TENS will be use for Active TENS.
    Intervention: Device: Transcutaneous Electrical Nerve Stimulation (TENS)
  • Experimental: Low Intensity TENS
    Low Intensity TENS will be applied for one arm of the study
    Intervention: Device: Transcutaneous Electrical Nerve Stimulation (TENS)
  • No Intervention: No Treatment
    TENS unit in place but not turned on
    Intervention: Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Head and Neck Cancer Diagnosis
  • Oral mucositis diagnosis

Exclusion Criteria:

  • TENS use ≤ 5 years
  • Pacemaker
  • Pregnancy
Both
18 Years to 90 Years
No
Contact: Jennifer E Lee, PhD 319-384-3052 jennifer-e-lee@uiowa.edu
United States
 
NCT01194466
University of Iowa 2031062
Yes
Jennifer E. Lee, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Jennifer E Lee, PhD University of Iowa
University of Iowa
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP