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Acupressure in Reducing Post-TBI Fatigue

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupressure
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hsiao-Yean Chiu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

4-point acupressure group

4 -point acupressure group

Usual care

Arm Description

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.

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.

The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2020
Last Updated
January 30, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04429126
Brief Title
Acupressure in Reducing Post-TBI Fatigue
Official Title
The Effect of Acupressure on Relieving Fatigue Following Traumatic Brain Injury: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4-point acupressure group
Arm Type
Experimental
Arm Description
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.
Arm Title
4 -point acupressure group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator.
Intervention Type
Behavioral
Intervention Name(s)
Acupressure
Intervention Description
Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.
Primary Outcome Measure Information:
Title
Fatigue
Description
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Memory function
Description
The function will be measured by using the Rey Auditory Verbal Learning Test
Time Frame
4 weeks
Title
Attention function
Description
The function will be measured by using the Trail Making Test
Time Frame
4 weeks
Title
Heart rate variability
Description
We will measure HRV parameter using the device of My ECG E3-8010
Time Frame
My ECG E3-8010
Title
Brain waves
Description
measured by the NeuroSky MindWave Mobile 2
Time Frame
4 weeks
Title
Sleep quality
Description
Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Yean Chiu, PhD
Organizational Affiliation
School of Nursing, Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hsiao-Yean Chiu
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acupressure in Reducing Post-TBI Fatigue

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