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Head and Neck CancerNCT07051265

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

A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Acupressure in people with Head and Neck Cancer and Cancer Pain, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 100 years
Conditions the study is for
Head and Neck Cancer, Cancer Pain
What is being tested?
Transcutaneous Electrical Nerve Stimulation (TENS) and Acupressure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteTaiwan
Study dates
1 Apr 2025to 1 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Participant inclusion criteria:

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

Participant exclusion criteria:

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

Other trials in Taiwan

About this study

Official title: Effect of Transcutaneous Electrical Nerve Stimulation (TENS) 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.
Read the detailed description

Study Procedure:

  1. 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.
  2. 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.
  1. 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.

Being tested
Transcutaneous Electrical Nerve Stimulation (TENS), Acupressure
Keywords
Transcutaneous Electrical Nerve Stimulation, Acupressure, Cancer pain, Head and neck cancer, Quality of life, emotional distress
Medical subject headings
Head and Neck Neoplasms, Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Electrical Nerve Stimulation (TENS)Behavioural

    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.

  • AcupressureBehavioural

    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.

Study groups in NCT07051265
Study groupRoleWhat they receive
Control groupNo interventionMaintain normal treatment without any intervention
Transcutaneous Electrical Nerve Stimulation (TENS)ExperimentalThe transcutaneous electrical stimulation group used a transcutaneous electrical nerve stimulator daily, with electrode patches attached to the unilateral Hegu and Lieque points respectively, providing 20 minutes of 80-100 HZ TENS, 3 times a day, and the electrical stimulation was adjusted to a level that the subjects felt was comfortable.
Receives: Behavioral: Transcutaneous Electrical Nerve Stimulation (TENS)
AcupressureExperimentalThe acupressure group selected Hegu and Lieque points for the treatment, placed the acupoint stickers on the acupoints of both hands, and pressed each acupoint with the thumb and index finger for 1 minute, 3 times a day, each time for about 4 minutes.
Receives: Behavioral: Acupressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numerical Rating Scale

    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).

    Measured: Daily for up to 14 days

Secondary outcomes (2)

  1. Brief Symptom Rating Scale

    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).

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients with head and neck cancer were randomly assigned to an intervention group or a control group using computer random numbers. The intervention group was further divided into two groups: transcutaneous electrical nerve stimulation intervention and acupoint pressing measures. The transcutaneous electrical stimulation group used a transcutaneous electrical nerve stimulator daily, with electrode patches attached to the unilateral Hegu and Lieque points for 20 minutes of 80-100 Hz TAES stimulation, three times a day, and the electrical stimulation was adjusted to a level that the subjects felt was comfortable. The acupressure group also selected Hegu and Lieque points for the treatment, placed the acupoint stickers on the acupoints of both hands, and pressed each acupoint with the thumb and index finger for 1 minute, 3 times a day, each time for about 4 minutes. The control group took the original analgesics and did not receive any acupoint stimulation.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07051265
Sponsor's protocol ID
KSVGH25-CT4-03
Status last verified
Jun 2025
First submitted
25 May 2025
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

    PubMed 11733293

  • Brant JM, Eaton LH, Irwin MM. Cancer-Related Pain: Assessment and Management With Putting Evidence Into Practice Interventions . Clin J Oncol Nurs. 2017 Jun 1;21(3 Suppl):4-7. doi: 10.1188/17.CJON.S3.4-7.

    PubMed 28524908

  • Chou YH, Yeh ML, Huang TS, Hsu H. Acupoint stimulation improves pain and quality of life in head and neck cancer patients with chemoradiotherapy: A randomized controlled trial. Asia Pac J Oncol Nurs. 2021 Dec 25;9(1):61-68. doi: 10.1016/j.apjon.2021.11.002. eCollection 2022 Jan.

    PubMed 35528798

  • Ge L, Wang Q, He Y, Wu D, Zhou Q, Xu N, Yang K, Chen Y, Zhang AL, Hua H, Huang J, Hui KK, Liang F, Wang L, Xu B, Yang Y, Zhang W, Zhao B, Zhu B, Guo X, Xue CC, Zhang H; International Trustworthy traditional Chinese Medicine Recommendations (TCM Recs) Working Group. Acupuncture for cancer pain: an evidence-based clinical practice guideline. Chin Med. 2022 Jan 5;17(1):8. doi: 10.1186/s13020-021-00558-4.

    PubMed 34983587

  • Gift AG. Visual analogue scales: measurement of subjective phenomena. Nurs Res. 1989 Sep-Oct;38(5):286-8. No abstract available.

    PubMed 2678015

  • Harrington CB, Hansen JA, Moskowitz M, Todd BL, Feuerstein M. It's not over when it's over: long-term symptoms in cancer survivors--a systematic review. Int J Psychiatry Med. 2010;40(2):163-81. doi: 10.2190/PM.40.2.c.

    PubMed 20848873

  • Hermann GM, Iovoli AJ, Platek AJ, Wang C, Miller A, Attwood K, Bourgeois DJ, Singh AK. A single-institution, randomized, pilot study evaluating the efficacy of gabapentin and methadone for patients undergoing chemoradiation for head and neck squamous cell cancer. Cancer. 2020 Apr 1;126(7):1480-1491. doi: 10.1002/cncr.32676. Epub 2019 Dec 23.

    PubMed 31869451

  • He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233.

    PubMed 31855257

  • Kasasbeh MAM, McCabe C, Payne S. Cancer-related pain management: A review of knowledge and attitudes of healthcare professionals. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12625. Epub 2016 Dec 27.

    PubMed 28026070

  • Kramer S, Newcomb M, Hessler J, Siddiqui F. Prophylactic versus reactive PEG tube placement in head and neck cancer. Otolaryngol Head Neck Surg. 2014 Mar;150(3):407-12. doi: 10.1177/0194599813517081. Epub 2013 Dec 31.

    PubMed 24381015

  • Lee JE, Anderson CM, Perkhounkova Y, Sleeuwenhoek BM, Louison RR. Transcutaneous Electrical Nerve Stimulation Reduces Resting Pain in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double-Blind Pilot Study. Cancer Nurs. 2019 May/Jun;42(3):218-228. doi: 10.1097/NCC.0000000000000594.

    PubMed 29649082

  • Lee MB, Lee YJ, Yen LL, Lin MH, Lue BH. Reliability and validity of using a Brief Psychiatric Symptom Rating Scale in clinical practice. J Formos Med Assoc. 1990 Dec;89(12):1081-7.

    PubMed 1982678

  • Lee MB, Liao SC, Lee YJ, Wu CH, Tseng MC, Gau SF, Rau CL. Development and verification of validity and reliability of a short screening instrument to identify psychiatric morbidity. J Formos Med Assoc. 2003 Oct;102(10):687-94.

    PubMed 14691593

  • Loh J, Gulati A. The use of transcutaneous electrical nerve stimulation (TENS) in a major cancer center for the treatment of severe cancer-related pain and associated disability. Pain Med. 2015 Jun;16(6):1204-10. doi: 10.1111/pme.12038. Epub 2013 Feb 25.

    PubMed 23438255

  • Maindet C, Burnod A, Minello C, George B, Allano G, Lemaire A. Strategies of complementary and integrative therapies in cancer-related pain-attaining exhaustive cancer pain management. Support Care Cancer. 2019 Aug;27(8):3119-3132. doi: 10.1007/s00520-019-04829-7. Epub 2019 May 11.

    PubMed 31076901

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Acupressure in people with Head and Neck Cancer and Cancer Pain, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: enrolling by invitation, as of the sponsor's last update on 4 Jul 2025. 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 Taiwan. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Numerical Rating Scale (time frame: Daily for up to 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07051265, which also lists 21 linked publications.

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 4 Jul 2025.

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