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Completed

NCT Number: NCT04429126

Acupressure in Reducing Post-TBI Fatigue

Fatigue is a common symptom experienced by patients with traumatic brain injury (TBI). Prior works have demonstrated that it may profoundly impact the ability to return to productive activity and cognitive functions. However, few interventions have been applied in this population.The purpose of the current will be to test the effect of acupressure on fatigue reduction after traumatic brain injury.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hsiao-Yean Chiu

Taipei, 110, Taiwan

About this study

Fatigue is a pervasive and critical long-lasting symptom experienced by patients with traumatic brain injury (TBI) and can persist up to months or years after head injury. However, thus far, only few non-pharmacological interventions, such as mindfulness, are implemented in reducing fatigue in TBI survivors. Prior works have suggested that acupressure can significantly improve fatigue in different populations, such as cancers survivors and patients with hemodialysis. Therefore, we would like to test whether acupressure effectively improve fatigue after TBI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with traumatic brain injury over 6 months with initial GCS (admitted GCS) from 3-12.
  • Aged between 20-65 years
  • Are able to communicate in Chinese and Mandarin
  • Are able to complete the questionnaires
  • Complain of tiredness and cannot be restored even after a rest.
  • No physical disability and visual impairment

Exclusion criteria

  • With skin lesion
  • had diagnosis of neuropathy and paraesthesia prior to study.

Treatment and study plan

acupressure

Behavioral

Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.

Primary outcomes

  1. Fatigue

    Time frame: 4 weeks

    Self-reported feeling of tiredness, is measured by the Chinese version of The Mental fatigue Scale (MFS, higher scores indicate greater mental fatigue) and Multidimensional Fatigue Inventory (MFI, higher score indicates more fatigue)

Secondary outcomes

  1. Memory function

    Time frame: 4 weeks

    The function will be measured by using the Rey Auditory Verbal Learning Test

  2. Attention function

    Time frame: 4 weeks

    The function will be measured by using the Trail Making Test

  3. Heart rate variability

    Time frame: My ECG E3-8010

    We will measure HRV parameter using the device of My ECG E3-8010

  4. Brain waves

    Time frame: 4 weeks

    measured by the NeuroSky MindWave Mobile 2

  5. Sleep quality

    Time frame: 4 weeks

    Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

The Effect of Acupressure on Relieving Fatigue Following Traumatic Brain Injury: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2020
Registry last updated
Feb 1, 2022

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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