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

NCT07051265 | Enrolling By Invitation

• 1 other identifier: KSVGH25-CT4-03
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Head and Neck Cancer; Cancer Pain

Keywords

Transcutaneous Electrical Nerve Stimulation; Acupressure; Cancer pain; Head and neck cancer; Quality of life; emotional distress

Outcome Measures

Primary Outcomes (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).

  Daily for up to 14 days

Secondary Outcomes (2)

• Brief Symptom Rating Scale

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

• The Taiwanese version of the World Health Organization Quality of Life Questionnaire

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

Study Arms (3)

Control group

NO INTERVENTION

Maintain normal treatment without any intervention

Transcutaneous Electrical Nerve Stimulation (TENS)

EXPERIMENTAL

The 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.

Behavioral: Transcutaneous Electrical Nerve Stimulation (TENS)

Acupressure

EXPERIMENTAL

The 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.

Behavioral: Acupressure

Interventions

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.

Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Acupressure

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Related Publications (21)

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Related Links

• Development and Applications of the WHOQOL-Taiwan Version
• Pain mechanisms: A new theory: A gate control system modulates sensory input from the skin before it evokes pain perception and response
• Cancer Facts \& Figures 2018
• Transcutaneous Electrical Nerve Stimulation in Patients with CancerRelated Pain: A Systematic Review
• The Experiences and Outcomes of Promoting Cancer Painless College at a Medical Center
• Effects of an Acupoint Intervention on Improving Fatigue and Heart Rate Variability in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy
• A review on the psychometric properties of the WHOQOL-BREF
• The incidence of the top ten cancers

MeSH Terms

Conditions

Head and Neck Neoplasms; Cancer Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Acupressure

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies

Study Officials

• Lin Ling Li

  Supervision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Department Supervisor

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: July 4, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)