Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001307897
Ethics application status
Approved
Date submitted
14/12/2012
Date registered
17/12/2012
Date last updated
18/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture for acute stroke: a retrospective analysis with prospective data collection in Stroke Registry In Chang Gung Healthcare System (SRICHS)
Scientific title
Acupuncture for treating acute stroke patients: a retrospective analysis with propsective data collection in the Stroke Registry In Chang Gung Healthcare System (SRICHS)
Secondary ID [1] 281687 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute stroke 287975 0
Condition category
Condition code
Alternative and Complementary Medicine 288357 288357 0 0
Other alternative and complementary medicine
Stroke 288358 288358 0 0
Ischaemic
Stroke 288359 288359 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Acupuncture rationale: Traditional Chinese Medicine, Reasoning for treatment provided is based on historical context and patient’s clinical condition.
2. Details of needling:
2a) Number of needle insertions per subject per session: 2-4, bilateral and symmetrical
2b) Depth of insertion, based on a specified unit of measurement, or on a particular tissue level: scalp acupuncture-1 to 1.2 inch, extremities: 0.2 to 0.4 inch
2c) Response sought: de qi
2d) Needle stimulation: after manual insertion of needle, no further needle stimulation
2e) Needle retention time: 30min
2f) Needle type: diameter-#30, length-1.5-inch, manufacturer-Ching Ming Medical Device, material-stainless steel
3. Treatment regimen:
3a) Number of treatment sessions: until patient’s condition became stable and discharge from Neurology ward
3b) Frequency and duration of treatment sessions: the frequency was three times a week, and the duration of treatment session was 30min
3c) The overall duration of the observation: The participants will be observed throughout their hospital stay and the course of their treatments up until 3 months after their condition has become stable and they have been discharged from the Neurology ward
4. Other components of treatment: Details of other interventions administered to the acupuncture group: routine rehabilitation program if patients tolerable. No moxibustion, no cupping, no herbs.
5. Practitioner background: A fixed qualified professional senior practitioner, with more than a decade of experience.
Intervention code [1] 286225 0
Not applicable
Comparator / control treatment
This is an observational study where the controls observed in this trial were acute stroke patients who did not receive acupuncture treatments because they did not have any consultations from the neurologist.
Control group would receive usual treatment, including medication and/or primary neuro-rehabilitation if patient's condition was tolerable.
The participants will be observed throughout their hospital stay and the course of their treatments up until 3 months after their condition has become stable and they have been discharged from the Neurology ward.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288527 0
Neurological deficit measured using the NIHSS.
Timepoint [1] 288527 0
Participants will be assessed immediately once their condition is stable and have been discharged from the Neurology ward.
Secondary outcome [1] 300395 0
Daily activities measured using the Barthel index.
Timepoint [1] 300395 0
Participants will be assessed immediately once their condition is stable and have been discharged from the Neurology ward.
Secondary outcome [2] 300399 0
Medical complication measured using the rate of complication, including "stroke in evolution," "infection," "heart disease," "upper gastrointestinal bleeding," and "seizure."
Timepoint [2] 300399 0
Participants will be assessed immediately during their hospital stay until their condition is stable and have been discharged from the Neurology ward.

Eligibility
Key inclusion criteria
Acute stroke patients in neurology ward at Chang Gung Memorial Hospital, Linkou since Jan. 1, 2010 to Dec. 31, 2011.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not been registered in Stroke Registry In Chang Gung Healthcare System (SRICHS) or not enrolled in the Health Policy in Stroke Adjuvant Acupuncture Therapy (HPSAAT were excluded).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
9/02/2010
Date of last participant enrolment
Anticipated
31/12/2011
Actual
29/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4761 0
Taiwan, Province Of China
State/province [1] 4761 0

Funding & Sponsors
Funding source category [1] 286479 0
Self funded/Unfunded
Name [1] 286479 0
Country [1] 286479 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Yu-Sheng Chen
Address
Division of Chinese Acupuncture, Center for Traditional Chinese Medicine, Chang Gung Memorial Hospital, 8F., No.123, Dinghu Rd., Guishan Township, Taoyuan County 33378, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 285273 0
None
Name [1] 285273 0
Address [1] 285273 0
Country [1] 285273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288556 0
Institutional Review Board
Ethics committee address [1] 288556 0
Chang Gung Memorial Foundation
8F., No.123, Dinghu Rd., Guishan Township, Taoyuan County 33378, Taiwan (R.O.C.)
Ethics committee country [1] 288556 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 288556 0
22/08/2012
Approval date [1] 288556 0
04/09/2012
Ethics approval number [1] 288556 0
101-1687B

Summary
Brief summary
Expedited review.
Data were retrospectively collected from stroke patients in neurology ward at Chang Gung Memorial Hospital, Linkou since Jan. 1, 2010 to Dec. 31, 2011. Patients not been registered in SRICHS or not enrolled in the HPSAAT were excluded. Matched control group patients were randomly selected from whom did not receive acupuncture therapy among the SRICHS database by 1 : 4 age-sex-severity matching. Profiles including neurologic deficit, activities of daily living, complications, length of stay, and long-term outcome were recorded and evaluated, as well as timing of acupuncture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36662 0
Dr Yu-Sheng Chen
Address 36662 0
Division of Chinese Acupuncture, Center for Traditional Chinese Medicine, Chang Gung Memorial Hospital, 8F., No.123, Dinghu Rd., Guishan Township, Taoyuan County 33378, Taiwan (R.O.C.)
Country 36662 0
Taiwan, Province Of China
Phone 36662 0
+886-3-3196200 ext. 2613
Fax 36662 0
Email 36662 0
[email protected]
Contact person for public queries
Name 36663 0
Dr Geng-Hao Liu
Address 36663 0
Division of Chinese Acupuncture, Center for Traditional Chinese Medicine, Chang Gung Memorial Hospital, 8F., No.123, Dinghu Rd., Guishan Township, Taoyuan County 33378, Taiwan (R.O.C.)
Country 36663 0
Taiwan, Province Of China
Phone 36663 0
+886-9-75362734
Fax 36663 0
Email 36663 0
[email protected]
Contact person for scientific queries
Name 36664 0
Prof Tsong-Hai Lee
Address 36664 0
Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital, No.5, Fuxing St., Guishan Township, Taoyuan County 33305, Taiwan (R.O.C.)
Country 36664 0
Taiwan, Province Of China
Phone 36664 0
+886-3-3281200 ext. 8340
Fax 36664 0
Email 36664 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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