FatigueNCT04429126
Acupressure in Reducing Post-TBI Fatigue
A study testing Acupressure in people with Fatigue, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fatigue
- What is being tested?
- Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- With skin lesion
- had diagnosis of neuropathy and paraesthesia prior to study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Acupressure
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureBehavioural
Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.
| Study group | Role | What they receive |
|---|---|---|
| 4-point acupressure group | Experimental | 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. Receives: Behavioral: Acupressure |
| 4 -point acupressure group | Active comparator | 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. Receives: Behavioral: Acupressure |
| Usual care | No intervention | The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (5)
Memory function
The function will be measured by using the Rey Auditory Verbal Learning Test
Measured: 4 weeks
Attention function
The function will be measured by using the Trail Making Test
Measured: 4 weeks
Heart rate variability
We will measure HRV parameter using the device of My ECG E3-8010
Measured: My ECG E3-8010
Brain waves
measured by the NeuroSky MindWave Mobile 2
Measured: 4 weeks
Sleep quality
Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Jul 2020
- Primary completion18 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
- Investigators
- Hsiao-Yean Chiu, PhD, Principal investigator, School of Nursing, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429126
- Sponsor's protocol ID
- 109059-E
- Status last verified
- Jan 2022
- First submitted
- 10 Jun 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Relieving Fatigue Following Traumatic Brain Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04429126
- Acronym / sponsor ID
- 109059-E
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-point acupressure group | Experimental | Behavioral: AcupressureThe 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. |
| 4 -point acupressure group | Active comparator | Behavioral: AcupressureThe 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. |
| Usual care | No intervention | –The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- With skin lesion
- had diagnosis of neuropathy and paraesthesia prior to study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureTwo types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study. | Behavioural | 4 -point acupressure group, 4-point acupressure group |
Primary outcome
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)
5 secondary outcomes
Memory function
Time frame: 4 weeks
Attention function
Time frame: 4 weeks
Heart rate variability
Time frame: My ECG E3-8010
Brain waves
Time frame: 4 weeks
Sleep quality
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Yean Chiu, PhD principal investigator
School of Nursing, Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Fatigue, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022; AzTrials last refreshed its copy on 31 Oct 2026.