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

Jennifer E. Lee

Status: Completed

Conditions: Head Cancer; Neck Cancer; Pain

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01194466

University of Iowa 201009732

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Head and Neck Cancer Diagnosis
• Oral mucositis diagnosis

Exclusion criteria

• TENS use ≤ 5 years
• Pacemaker
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

41 participants in 3 patient groups

Active TENS

Active Comparator group

Description:

Active high frequency TENS will be use for Active TENS.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Placebo (low intensity) TENS

Experimental group

Description:

Placebo TENS will be applied for one arm of the study

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

No Treatment

Sham Comparator group

Description:

TENS unit in place but not turned on

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)