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NCT Number: NCT07051265

Effect of Transcutaneous Electrical Nerve Stimulation or Acupressure on Pain in Patients With Head and Neck Cancer

This clinical trial aims to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS), acupressure intervention, or standard care (control group) for pain management in participants hospitalized with head and neck cancer. This study aims to answer the following questions:

* Is TENS or acupressure intervention effective in reducing pain in participants hospitalized with head and neck cancer compared with the control group? * Does TENS or acupressure intervention improve psychological distress (measured by the Brief Health Inventory (BMI)) in these participants? * Does TENS or acupressure intervention improve the quality of life of participants hospitalized with head and neck cancer? Researchers will compare the effects of TENS, acupressure, and standard care to assess the effects of each group on pain, psychological distress (measured by the Brief Health Inventory (BMI)), and quality of life.

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Key information

Conditions

Head and Neck Cancer Cancer Pain Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

About this study

Study Procedure:

A. If the participant agrees to participate in the study and signs the informed consent form, the researcher will ask them to complete a questionnaire. The questionnaire includes basic demographic information, pain level, emotional distress (Brief Symptom Rating Scale), and quality of life survey. It takes about 10 minutes to complete the questionnaire.

B. Participants will be randomly assigned to one of the following three groups:

  • Transcutaneous electrical nerve stimulation (TENS) combined with standard treatment
  • Acupressure combined with standard treatment
  • Standard treatment (control group) C. Before and after daily intervention, all three groups of participants will complete a numerical rating scale (0-10 points) to assess pain intensity, and their vital signs will be recorded.

D. After one week of intervention, every week thereafter, and before discharge, participants will complete a numerical rating scale (0-10 points), the Brief Symptom Rating Scale (BSRS), and the World Health Organization Quality of Life Brief Form (WHOQOL-BREF).

Possible side effects and how to cope with them:

  • TENS or acupressure: Participants may experience soreness, tingling, pressure, or mild pain when using TENS or acupressure to treat the Hegu (LI4) and Lieque (LU7) points. These are normal reactions and are generally well tolerated. No studies have shown any harmful side effects from stimulating these points. If discomfort is too great, the intensity of stimulation can be adjusted.
  • Risks to participants: Participants can stop at any time if they feel discomfort during the study. Participants can also contact the study's emergency contact for assistance.

Expected benefits:

Previous research and traditional practices have shown that acupressure on the Hegu (LI4) and Lieque (LU7) points may help regulate the flow of Qi and blood, enhance lung function, improve blood circulation, and relieve pain and discomfort. While researchers cannot guarantee that this study will benefit participants, acupressure may help healthcare professionals better understand how to support clinical inpatients (non-participants) and may benefit others in the future.

Participant privacy is protected: Researchers will only collect information necessary for this study. All participant personal information and questionnaire responses will remain confidential. Participants' names and personal identifying information will not be used; instead, researchers will assign participants a code to ensure that the participant's identity remains anonymous in all records.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participant inclusion criteria:

  • Age ≥ 20 years old
  • Inpatients diagnosed with head and neck cancer
  • Conscious and able to communicate in Mandarin and Taiwanese
  • Suffering from pain problems and requiring pain medication
  • Participants agree to participate in this study.

Participant exclusion criteria:

  • Those with nerve conduction disorders
  • Pregnant women
  • Those whose pain is not caused by tumors
  • Those with a history of epilepsy
  • Those with skin infections
  • Those who are allergic to the patch
  • Those with implanted devices such as pacemakers
  • Those who still disagree with the study content and are unable to cooperate with the researchers after the researchers' explanation.

Treatment and study plan

Transcutaneous electrical nerve stimulation (TENS)

Behavioral

Participants received TENS therapy at two specific acupoints - Hegu (LI4) and Lieque (LU7). Surface electrodes were placed over the acupoints, and stimulation was delivered using a standard TENS device.

acupressure

Behavioral

The acupressure group placed the acupoint patches on the Hegu and Lieque points on both hands and pressed each acupoint with the index finger and thumb for 1 minute, 3 times a day, each time for about 4 minutes.

Primary outcomes

  1. Numerical Rating Scale

    Time frame: Daily for up to 14 days

    A self-reporting tool to assess subjective experience (such as symptoms, feelings and attitudes). On a 10 mm straight line (0-10 points from left to right), the far left side represents no pain (0 points) and the far right side represents extreme pain (10 points). The higher the pain score, the more severe the pain. The subjects were asked to describe the pain intensity themselves. This method has a good intraclass correlation coefficient for pain assessment (ICC=0.99). After the subjects started the trial, they were required to fill in the numerical scale three times a day (9 am, 12 pm and 4 pm). Each filling was divided into before the intervention (pretest) and after the intervention (posttest). Therefore, the pain index will be recorded 6 times a day. The numerical scale will be filled in until they are discharged from the hospital or transferred to another ward (whichever comes first).

Secondary outcomes

  1. Brief Symptom Rating Scale

    Time frame: Baseline, Day 7, and Day 14 or until discharge/transfer, whichever occurred first.

    The Brief Symptom Rating Scale (BSRS-5) compiled by Professor Li Mingbin can quickly understand an individual's psychological care needs. The BSRS consists of 5 questions (measuring anxiety, anger, depression, low self-esteem and insomnia) and 1 additional question. Participants used a 5-point Likert scale (0-4 points), where 0 represented "not at all", 1 represented "mild", 2 represented "moderate", 3 represented "severe", and 4 represented "very severe", with a total score of 0-20 points. The higher the score, the more severe the psychological distress. The Cronbach's α value measured for the sample in this study was 0.829, which has a high internal consistency reliability. Participants will complete the BSRS-5 assessment once at the beginning of the program, and then complete the follow-up once a week (start day (pre-test) + 7 days, 14 days, 28 days, etc.) until they are discharged from the hospital or transferred to another ward (whichever comes first).

  2. The Taiwanese version of the World Health Organization Quality of Life Questionnaire

    Time frame: Baseline, Day 7, and Day 14 or until discharge/transfer, whichever occurred first.

    The World Health Organization Quality of Life Questionnaire (WHOQOL BREF) developed by Yao Qizhi was used to measure the overall quality of life, general health status and 24 aspects of quality of life, which are divided into four categories: "physical health (covering the original physical and independence categories), psychological (covering the original psychological and spiritual/religious/personal belief categories), social relationships and environment". The scale consists of 28 questions, each with a score range of 1-5 points, and a total score of 28-140 points. The higher the score, the better the quality of life. Participants will complete the World Health Organization Quality of Life Questionnaire Taiwan Version (pre-test) once after the start of the program, and then complete it once a week (starting day + 7 days, 14 days, 28 days, etc.) until they were discharged or transferred to other wards whichever came first.

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Effect of Transcutaneous Electrical Nerve Stimulation (TENS) or Acupressure on Pain in Patients With Head and Neck Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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