Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Cancer Pain

Pain

Head and Neck Neoplasms

Stomatitis

Mucositis

Mouth Neoplasms

Quality of Life

Oral Cancer

Laryngeal Cancer

Lip and Oral Cavity Cancer

Active high frequency TENS will be use for Active TENS.

Placebo TENS will be applied for one arm of the study

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).

Transcutaneous Electrical Nerve Stimulation (TENS)

Jennifer E Lee, PhD

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.

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

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.

Jennifer E. Lee

Post Doctoral Research Fellow

Active high frequency TENS will be use for Active TENS.

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).

Active TENS

Low Intensity TENS will be applied for one arm of the study

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).

Low Intensity TENS

TENS unit in place but not turned on

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).

No Treatment

All participants' characteristics, prior to first treatment

All Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Jen Lee

Each participant received an Active TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Active TENS condition. Active TENS was delivered for 30 minutes at a frequency of 125Hz and a pulse duration of 100 2s on continuous mode output (calibrated using an oscilloscope before the study). Transcutaneous electrical nerve stimulation intensity was increased by the allocator until patients reported a ''maximally strong but comfortable sensation'' to ensure an analgesic effect.

Each participant received an Placebo TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Placebo TENS condition. Placebo TENS parameters were identical to active TENS (125 Hz, 100 2s). A novel, transient placebo TENS unit, previously tested and validated, was used. The intensity was increased until patients first felt ''any sensation at all (sensory threshold)'' in any electrode (ie, they did not have to reach sensory threshold in all electrodes). The placebo device then provided a current for 30 seconds and decreased gradually over 15 seconds to 0 output (ie, 45 seconds from the first sensory threshold). An indicator light remained on for the remainder of the visit so it appeared to the participant and outcomes assessor that the unit was still producing current.

Placebo TENS

Each participant received a No TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the No TENS condition. No TENS parameters were identical to active and placebo TENS, except that (1) the unit was never turned on and (2) participants were told that the unit was not on.

No TENS

The sample was adults (18 or greater) years old with oropharyngeal or laryngeal cancer.

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

Active high frequency TENS will be used visit 1 Washout 6 days Placebo for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2

Order: Active, Placebo, No TENS

Placebo low frequency TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2

Order: Placebo, Active, No TENS

No TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days Placebo Low Intensity TENS visit 3- 7 days after visit 2

Spots Global Cancer Trial Database for functional pain