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

NCT01194466 | Completed Results DMC FDA Device

• 1 other identifier: University of Iowa 201009732
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head Cancer; Neck Cancer; Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)

  Participants rated 0-10 pain intensity in head/neck cancer area using one number (where their disease was located) by a vertical line on a horizontal 10-cm visual analog scale (VAS) from 0 "no pain" to 10 "worst possible pain." Possible scores ranged from 0-10 (10=worse pain). VAS was assessed two times each visit: (1) Pre-VAS: start of visit, (2) Post-VAS: end of the visit. The outcome measure was each person's change in pain: Pre-VAS minus Post-VAS, to create VAS change score. An average of all participants' VAS change score was calculated for each TENS condition (Active, Placebo, No TENS) and used as the dependent measure.

  The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions

Study Arms (3)

Active TENS

ACTIVE COMPARATOR

Active high frequency TENS will be use for Active TENS.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Placebo (low intensity) TENS

EXPERIMENTAL

Placebo TENS will be applied for one arm of the study

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

No Treatment

SHAM COMPARATOR

TENS unit in place but not turned on

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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).

Also known as: EMPI Select

Active TENS; No Treatment; Placebo (low intensity) TENS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Head and Neck Cancer Diagnosis
• Oral mucositis diagnosis

You may not qualify if:

• TENS use ≤ 5 years
• Pacemaker
• Pregnancy

Sponsors & Collaborators

• Jennifer E. Lee: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Pain; Mouth Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Stomatitis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Pharyngeal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Jen Lee
• Organization: Mount Mercy University/The University of Iowa

jlee@mtmercy.edu

3193231623

Study Officials

• Jennifer E Lee, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Doctoral Research Fellow

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 3, 2010
• Study Start: May 15, 2011
• Primary Completion: August 14, 2012
• Study Completion: August 14, 2012
• Last Updated: September 17, 2019
• Results First Posted: September 17, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)