Acupoint Stimulation for Pain Reduction and the Associated Benefits in Head and Neck Cancer Patients Receiving Concurrent Chemoradiotherapy

NCT03640195 | Completed

• 1 other identifier: yahe7693
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to investigate the effect of Acupoint stimulation on pain reduction, and fatigue, anxiety and depression and quality of life in Head neck cancer receiving Concurrent Chemoradiotherapy.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Difference between the two groups from Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

  Pain intensity was assessed using visual analogue scales (VAS) , which is a 10-cm continuous line to assess the subjective perception of pain in the case, with a score of 0 on the leftmost end of the line indicating "painless" and 10 points indicating The "most severe pain" and the reliability of pain assessment , and all participants received this linear tool measurement, recording a total of five

  from enrollment to end of treatment at 6 weeks

Secondary Outcomes (3)

• Difference between the two groups from Baseline in fatigue on Brief Fatigue Inventory at 6 Weeks

  from enrollment to end of treatment at 6 weeks

• Difference between the two groups from Baseline in Anxiety and depression on Hospital Anxiety and depression scale

  from enrollment to end of treatment at 6 weeks

• Difference between the two groups from Baseline in quality of life European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H & N 35)

  from enrollment to end of treatment at 6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Transcutaneous nerve electrical stimulation and Auricular acupressure.

Other: Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure

Control group

NO INTERVENTION

without intervention

Interventions

Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure OTHER

Experimental group received Acupoint stimulation, Transcutaneous acupoint electrical stimulation20 minutes/weeks, once a week for six consecutive weeks. The second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3). each point is 1min, 5days/week, 3 times/day.

Experimental group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy
• Must be able to communicate clearly
• Must be above age 20

You may not qualify if:

• Previous radiotherapy
• History of arrhythmia or use of a pacemaker
• Local swelling or infection over the acupoint area

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Seeds

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention is divided into two parts: part of The Experimental group received Transcutaneous acupoint electrical stimulation 20 minutes/weeks, the acupoints are unilateral Hegu (LI4) and LU7; This study used Transcutaneous nerve electrical stimulation , 20 minutes each time, once a week for six consecutive weeks. The second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3).A seeds embedding method with seeds attached to the four sides of the unilateral ear, using the thumb and forefinger to apply pressure, the participants will feel sour, each point is 1min, 5days/week, 3 times/day. Control group: without intervention

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 21, 2018
• Study Start: October 1, 2016
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: August 21, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share