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Completed

NCT Number: NCT03640195

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Data were collected from 92 participants in northern Taiwan medical center Radiation Outpatient.They are randomly assigned to the experimental group (n=46) with Acupoint stimulation and control group(n=46). Outcomes were assessed according to the pain, Brief fatigue inventory, Hospital anxiety and depression scale, quality of life, five repeated measures was conducted.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: from enrollment to end of treatment 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

Secondary outcomes

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

    Time frame: from enrollment to end of treatment at 6 weeks

    Fatigue is using the friction fatigue inventory (BFI) ; it is a nitrate-item self-reported for measuring fatigue intensity and interference with functionality. Item 1-3 describes the fatigue strength, during The past 24 hour using a visual analogue scale (VAS) ranging from 0 (no fatigue) to 10 (very severely fatigued). Item 4-9 describes interferes with certain functions such as daily activity, including work, walking ability, normal work, Relations with others, and enjoyment in life. Each item was rated on a scale of 0 (does not interfere) to 10 (completely interferes). Its average score for each item indicates its severity of fatigue 1-3 points of helpful mild fatigue, 4 -6 is divided into moderate, 7-10 is divided into severe fatigue.

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

    Time frame: from enrollment to end of treatment at 6 weeks

    The Hospital Anxiety and depression scale (HADS) is composed of two seven-item subscales, one specifically targeting anxiety (HADS-A) and the other focusing on depression (HADS-D). The HADS is a 14-item measure divided into 2 subscales (anxiety and depression), HADS_A and HADS_D are scored separately, the topic arrangement is staggered, and the reverse problem is scored in reverse. The total score is between 0-21 points. Below 8 points means no anxiety and depression; 8 to 10 points may be anxiety and depression. And anxiety and depression of 10 points or more

  3. 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)

    Time frame: from enrollment to end of treatment at 6 weeks

    European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H & N 35) is a specific questionnaire developed by the European Organisation for Research and Treatment of Cancer for head and neck cancer. The module includes 35 questions Assessing symptoms and side effects of treatment, social function and body image/sexuality .This scale includes seven symptoms subscales that measure pain, swallowing, senses problems, speech problems, trouble with social eating, trouble with social Contact, and less sexuality, and also has 11 subscales related with teeth, opening mouth, dry mouth, sticky saliva, coughing, ill feeling, weight loss, weight gain, use of painkillers, nutritional supplements, and feeding tubes. Standardize the original scores, with scores ranging from 0 to 100, with higher scores representing more serious problems.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Acupoint Stimulation for Pain Reduction

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2018
Registry last updated
Aug 21, 2018

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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