Acupressure in Reducing Post-TBI Fatigue

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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Behavioral: Acupressure

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Hsiao-Yean Chiu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-point acupressure group; The 5-point acupressure group will be instructed on the following acupressure points: sanyinjiao (SP6), Zu San Li (ST36), shenmen (TF4), Yongquan (KI-1), and He Gu (LI4). Bilateral 1.5 min for each point, three times daily for 4 weeks.	Behavioral: Acupressure; Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.
Active Comparator: 4 -point acupressure group; The 2-point acupressure group will be instructed on the following acupressure points: He Gu (LI4) and Tai Chong (LV3). Bilateral 1.5 min for each point, three times daily for 4 weeks.	Behavioral: Acupressure; Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.
No Intervention: Usual care; The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Hsiao-Yean Chiu, PhD, School of Nursing, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 30, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 109059-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No