Acupressure in Reducing Post-TBI Fatigue

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429126
• Other study ID #: 109059-E
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 31, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue

Intervention

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

Locations

Country	Name	City	State
Taiwan	Hsiao-Yean Chiu	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	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)	4 weeks
Secondary	Memory function	The function will be measured by using the Rey Auditory Verbal Learning Test	4 weeks
Secondary	Attention function	The function will be measured by using the Trail Making Test	4 weeks
Secondary	Heart rate variability	We will measure HRV parameter using the device of My ECG E3-8010	My ECG E3-8010
Secondary	Brain waves	measured by the NeuroSky MindWave Mobile 2	4 weeks
Secondary	Sleep quality	Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index	4 weeks