Head CancerNCT01194466
Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Head Cancer and Neck Cancer, run by Jennifer E. Lee at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head Cancer, Neck Cancer, Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2011to 14 Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and Neck Cancer Diagnosis
- Oral mucositis diagnosis
Who cannot join
- TENS use ≤ 5 years
- Pacemaker
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial
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
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- 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
- Medical subject headings
- Head and Neck Neoplasms, Pain, Mouth Neoplasms, Laryngeal Neoplasms, Oropharyngeal Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called EMPI Select
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).
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | Active high frequency TENS will be use for Active TENS. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Placebo (low intensity) TENS | Experimental | Placebo TENS will be applied for one arm of the study Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| No Treatment | Sham comparator | TENS unit in place but not turned on Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study start15 May 2011
- Primary completion14 Aug 2012
- Study completion14 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer E. Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer E. Lee, University of Iowa
- Investigators
- Jennifer E Lee, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194466
- Sponsor's protocol ID
- University of Iowa 201009732
- Status last verified
- Aug 2019
- First submitted
- 1 Sep 2010
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01194466
- Acronym / sponsor ID
- University of Iowa 201009732
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jennifer E. LeeUniversity, hospital or other
- Study start
- 15 May 2011 (actual)
- Primary completion
- 14 Aug 2012 (actual)
- Study completion
- 14 Aug 2012 (actual)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Posted 17 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Active high frequency TENS will be use for Active TENS. |
| Placebo (low intensity) TENS | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Placebo TENS will be applied for one arm of the study |
| No Treatment | Sham comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)TENS unit in place but not turned on |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Head and Neck Cancer Diagnosis
- Oral mucositis diagnosis
Key exclusion criteria (3 listed)
- TENS use ≤ 5 years
- Pacemaker
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: EMPI SelectFour 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). | Device | Active TENS, No Treatment, Placebo (low intensity) TENS |
Primary outcome
Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer E Lee, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Head Cancer and Neck Cancer, run by Jennifer E. Lee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS) (time frame: The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.