Head Cancer, Neck Cancer, Pain
Conditions
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
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.
Interventions
DEVICETranscutaneous 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).
Sponsors
Jennifer E. Lee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Head and Neck Cancer Diagnosis * Oral mucositis diagnosis
Exclusion criteria
* TENS use ≤ 5 years * Pacemaker * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS) | The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions | 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. |
Countries
United States
Participant flow
Recruitment details
This prospective, randomized, double-blinded, and placebo controlled study was conducted between May 2011 and August 2012 at the University of Iowa Hospitals and Clinics (Clinical-Trials.gov identifier, NCT01194466)
Pre-assignment details
Study exclusion criteria were (1) TENS use within 5 years, (2) conditions precluding TENS use (pacemaker, nickel allergy), (3) pain intensity less than 1 of 10 with rest or swallowing, (4) sensory impairment (could not identify sharp and dull stimuli on face), and/or (5) inability to read, write, or follow directions.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants' characteristics, prior to first treatment | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 | 0 / 41 |
Outcome results
Primary
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.
Time frame: The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions
Population: The sample was adults (18 or greater) years old with oropharyngeal or laryngeal cancer.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS) | -1.4 change units on a VAS scale | Standard Deviation 1.3 |
| Placebo TENS | Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS) | -0.6 change units on a VAS scale | Standard Deviation 1.1 |
| No TENS | Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS) | 0.1 change units on a VAS scale | Standard Deviation 0.9 |