Evaluating the effectiveness of acupuncture for traumatic brain injury and stroke
| ISRCTN | ISRCTN17494271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17494271 |
| Secondary identifying numbers | EJTCM-D-21-00361 |
- Submission date
- 27/07/2021
- Registration date
- 30/07/2021
- Last edited
- 30/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
A traumatic brain injury (TBI) is an injury that affects how the brain works. A stroke occurs when the blood supply to part of your brain is interrupted or reduced. TBI and stroke are major causes of death and disability worldwide. Acupuncture has been used as a supplemental treatment for patients with TBI and stroke. The aim of this study is to evaluate the effects of acupuncture treatment for patients with TBI and stroke.
Who can participate?
Patients with TBI or stroke
What does the study involve?
Participants are invited for radial pressure wave measurement before and 20 minutes after acupuncture treatment and after 3 weeks of treatment to observe the effect of the acupuncture treatment.
What are the possible benefits and risks of participating?
Patients may benefit from evaluating the progress of treatment in the future. The radial pulse measuring device is non-invasive with no additional risk.
Where is the study run from?
Hualien Tzu Chi Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
January 2020 to December 2020
Who is funding the study?
Hualien Tzu Chi Hospital (Taiwan)
Who is the main contact?
Dr Jhong-Kuei Chen (Public)
samtati@gmail.com
Contact information
Public
No. 707, Sec 3
Zhongyang Road
Hualien
Hualien
970
Taiwan
| Phone | +886 (0)3 8561825 |
|---|---|
| hlmweb@tzuchi.com.tw |
Study information
| Study design | Observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | https://1drv.ms/b/s!AlEOtDPheSzjzmrm23FgDMwyB1Nt?e=OkhDHV |
| Scientific title | Using radial pulse wave as hemodynamic measurements to quantify the effects of acupuncture therapy for patients with traumatic brain injury and ischemia stroke |
| Study acronym | RPATTBI |
| Study objectives | Harmonic indicators may become risk indicators for traumatic brain injury (TBI) patients. |
| Ethics approval(s) | Approved 01/01/2020, Institutional Review Board of Hualien Tzu Chi Hospital (707, Sec. 3, Chung-Yang Rd., Hualien, 97002, Taiwan, R.O.C.; +886 (0)3 38561825 Ext. 12124; no email provided), ref: IRB108-200-B |
| Health condition(s) or problem(s) studied | Risk factors in traumatic brain injury patients |
| Intervention | All subjects undergo radial pressure wave measurement. Spectrum analysis of radial pressure wave is calculated and transformed into Fourier series coefficients Cn and Pn. The clinical research method is divided into two stages, which are the initial measurement and the subsequent follow-up measurement. Each stage will involve two TD01C measurements. The obtained harmonic index will be analyzed by linear regression, chi-square test, etc, to assess whether stroke, traumatic brain injury status and harmonic index are related, and whether these harmonic indicators can assist physicians in monitoring stroke and traumatic brain injury. The process provides a physician's clinical warning function. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Radial pulse spectrum measured using micro-pressure transducer before and 20 minutes after acupuncture treatments 2. Clinical severity measured using Glasgow Coma Scale before and 20 minutes after acupuncture treatments |
| Secondary outcome measures | 1. Radial pulse spectrum measured using micro-pressure transducer after 3 weeks of treatment 2. Clinical severity measured using Glasgow Coma Scale after 3 weeks of treatment |
| Overall study start date | 01/01/2020 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. New stroke (in the last half-year) and traumatic brain injury patients in Hualien Tzu Chi Hospital 2. Any age or gender |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/05/2020 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Zhongyang Road
Hualien
970
Taiwan
Sponsor information
Hospital/treatment centre
No. 707, Sec 3
Zhongyang Road
Hualien
Haulien
970
Taiwan
| Phone | +886 (0)3 8561825 Ext. 13156 |
|---|---|
| hlmweb@tzuchi.com.tw |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/08/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
29/07/2021: Trial's existence confirmed by the institutional review board of Hualien Tzu Chi Hospital.
