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The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial


N/A
18 Years
90 Years
Open (Enrolling)
Both
Head Cancer, Neck Cancer, Pain

Thank you

Trial Information

The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial


Inclusion Criteria:



- Head and Neck Cancer Diagnosis

- Oral mucositis diagnosis

Exclusion Criteria:

- TENS use ≤ 5 years

- Pacemaker

- Pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

10cm Visual Analog Scale (VAS)

Outcome Description:

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.

Outcome Time Frame:

3 weeks

Safety Issue:

No

Principal Investigator

Jennifer E Lee, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa

Authority:

United States: Institutional Review Board

Study ID:

University of Iowa 2031062

NCT ID:

NCT01194466

Start Date:

May 2011

Completion Date:

June 2012

Related Keywords:

  • Head Cancer
  • Neck Cancer
  • Pain
  • 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
  • Head and Neck Neoplasms

Name

Location
University of Iowa Iowa City, Iowa  52242