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| ID | Type | Description | Link |
|---|---|---|---|
| 103-5150C | Other Identifier | Chang Gung Medical Foundation Institutional Review Board |
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The purpose of this study is to determine the therapeutic effect of acupuncture on severe head injury under conventional treatment. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.
Objective: To investigate the therapeutic effect of acupuncture on severe head injury under conventional treatment.
Methods: 90 subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less) are randomly divided into acupuncture, laser acupuncture and control group. We use restoring consciousness acupuncture (GV26 and 12 Well points) to treat the subjects 3 sessions per week under conventional treatment at Department of Neurosurgery. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' GCS and muscle power is measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental | acupuncture on GV26 and 12 Well points |
|
| laser acupuncture | Experimental | laser acupuncture on GV26 and 12 Well points |
|
| control group | Sham Comparator | laser acupuncture without laser output in control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | acupuncture on GV26 and 12 Well points |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Coma Scale (GCS) | Eye response (E) There are four grades starting with the most severe:
There are five grades starting with the most severe:
There are six grades:
The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Power (MP) | Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement
The 4 muscle groups were assessed on the 0 to 5 scale and scores were summed before and after treatment during hospitalization. The total score ranges from 0-20, with higher score indicating better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Long Hu, MS | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21209492 | Background | DeFina PA, Fellus J, Thompson JW, Eller M, Moser RS, Frisina PG, Schatz P, Deluca J, Zigarelli-McNish M, Prestigiacomo CJ. Improving outcomes of severe disorders of consciousness. Restor Neurol Neurosci. 2010;28(6):769-80. doi: 10.3233/RNN-2010-0548. | |
| 11222792 | Background | Jennett B, Adams JH, Murray LS, Graham DI. Neuropathology in vegetative and severely disabled patients after head injury. Neurology. 2001 Feb 27;56(4):486-90. doi: 10.1212/wnl.56.4.486. |
| Label | URL |
|---|---|
| Acupuncture for Disorders of Consciousness - A Case Series and Review | View source |
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Exclusion criteria: dilated pupils without light reflex, unstable vital signs, serious complication during therapeutic course, serious multiple injuries, withdrawal by subject, physician decision, without informed consent.
Patients with severe traumatic brain injury (Glasgow Coma Scale, GCS ≤ 8) admitted to neurosurgical intensive care unit (NSICU) were enrolled and randomly divided into three groups sequentially.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | acupuncture on Shuigou (GV26) and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points |
| FG001 | Laser Acupuncture | laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points |
| FG002 | Control Group | laser acupuncture without laser output in control group. control: sham laser acupuncture on GV26 and 12 Well points |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | acupuncture on GV26 and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points |
| BG001 | Laser Acupuncture | laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glasgow Coma Scale (GCS) | Eye response (E) There are four grades starting with the most severe:
There are five grades starting with the most severe:
There are six grades:
The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome. | The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The GCS was measured before and after treatment during hospitalization. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | acupuncture on GV26 and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points |
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Inclusion criteria leading to small numbers (24/583 in 2.5 years) of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wen-Long Hu, Deputy Director, Department of Chinese Medicine | Kaohsiung Chang Gung Memorial Hospital | +886-7-7317123 | 2334 | oolonghu@gmail.com |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| laser acupuncture |
| Other |
laser acupuncture on GV26 and 12 Well points |
|
| control | Other | sham laser acupuncture |
|
| 6 weeks |
| 16720934 | Result | Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8. |
| Efficacy of Stimulation at the Jing-Well Points of Meridians | View source |
| BG002 | Control Group | laser acupuncture without laser output in control group. control: sham laser acupuncture |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
acupuncture on GV26 and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points |
| OG001 | Laser Acupuncture | laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points |
| OG002 | Control Group | laser acupuncture without laser output in control group. control: sham laser acupuncture on GV26 and 12 Well points |
|
|
| Secondary | Muscle Power (MP) | Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement
The 4 muscle groups were assessed on the 0 to 5 scale and scores were summed before and after treatment during hospitalization. The total score ranges from 0-20, with higher score indicating better outcome. | The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The MP was measured before and after treatment during hospitalization. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Laser Acupuncture | laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points | 0 | 9 | 0 | 9 |
| EG002 | Control Group | laser acupuncture without laser output in control group. control: sham laser acupuncture on GV26 and 12 Well points | 0 | 6 | 0 | 6 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |