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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral Transcutaneous Electrical Nerve Stimulation (TENS)
  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.
• Behavioral Acupressure
  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 outcome measures

• Numerical Rating Scale [Time frame: Daily for up to 14 days]

Secondary outcome measures (2)

• Brief Symptom Rating Scale [Time frame: 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 [Time frame: Baseline, Day 7, and Day 14 or until discharge/transfer, whichever occurred first.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Taiwan · 1 center

• Kaohsiung Veterans General Hospital — Kaohsiung City

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. PMID 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. PMID 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. PMID 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/s13020-021-0055 PMID 34983587
• Gift AG. Visual analogue scales: measurement of subjective phenomena. Nurs Res. 1989 Sep-Oct;38(5):286-8. No abstract available. PMID 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. PMID 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. PMID 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. PMID 31855257

Identifiers

NCT: NCT07051265 · KSVGH25-CT4-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗