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NCT01194466 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2019-09-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Head and Neck Cancer Diagnosis * Oral mucositis diagnosis Exclusion Criteria: * TENS use ≤ 5 years * Pacemaker * Pregnancy
healthy Volunteers
false
maximum Age
90 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Active high frequency TENS will be use for Active TENS.
    intervention Names
    1. Device: Transcutaneous Electrical Nerve Stimulation (TENS)
    label
    Active TENS
    type
    ACTIVE_COMPARATOR
  2. description
    Placebo TENS will be applied for one arm of the study
    intervention Names
    1. Device: Transcutaneous Electrical Nerve Stimulation (TENS)
    label
    Placebo (low intensity) TENS
    type
    EXPERIMENTAL
  3. description
    TENS unit in place but not turned on
    intervention Names
    1. Device: Transcutaneous Electrical Nerve Stimulation (TENS)
    label
    No Treatment
    type
    SHAM_COMPARATOR
interventions
  1. arm Group Labels
    1. Active TENS
    2. No Treatment
    3. Placebo (low intensity) TENS
    description
    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).
    name
    Transcutaneous Electrical Nerve Stimulation (TENS)
    other Names
    1. EMPI Select
    type
    DEVICE
Study design
allocation
RANDOMIZED
intervention Model
CROSSOVER
masking Info
masking
SINGLE
who Masked
  1. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
41
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    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
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-7b53d11acf56e51c2df7
      requested nct id
      NCT01194466
      primary nct id
      NCT01194466
      source kind
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      source record id
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      source file sha256
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      payload sha256
      e24cda7055873ce68b521bee584b188cc7c952a6e6eb2fec461d13b41306750d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-7b53d11acf56e51c2df7
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01194466
      occurrences
      1. context exact
        NCT01194466
        end
        11
        exact text
        NCT01194466
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      source json pointer
      /studies/105/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2919e78a4a5f5a3114f666a3373b2bbba13a859e771eec88563f2333d04c3c48

    Preserved source evidence · Not medical advice