Head Injury
Conditions
Keywords
Acupuncture; laser acupuncture; traumatic brain injury
Brief summary
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.
Detailed description
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.
Interventions
OTHERacupuncture
acupuncture on GV26 and 12 Well points
OTHERlaser acupuncture
laser acupuncture on GV26 and 12 Well points
OTHERcontrol
sham laser acupuncture
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less) * with informed consent
Exclusion criteria
* dilated pupils without light reflex * serious complications during therapeutic course * interruption of therapeutic course * unfavored condition assessed by physician in charge * without informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glasgow Coma Scale (GCS) | 6 weeks | Eye response (E) There are four grades starting with the most severe: 1. No eye opening 2. Eye opening in response to pain stimulus. 3. Eye opening to speech. 4. Eyes opening spontaneously Verbal response (V) There are five grades starting with the most severe: 1. No verbal response 2. Incomprehensible sounds. 3. Inappropriate words. 4. Confused. 5. Oriented. Motor response (M) There are six grades: 1. No motor response 2. Decerebrate posturing accentuated by pain 3. Decorticate posturing accentuated by pain 4. Withdrawal from pain 5. Localizes to pain 6. Obeys commands The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Power (MP) | 6 weeks | Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement 1. Flicker of movement only 2. Movement possible when assisted by gravity or gravity is eliminated 3. Movement possible against gravity but without imposed resistance 4. Weak movement possible against gravity 5. Normal movement against gravity and against imposed resistance 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. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture acupuncture on GV26 and 12 Well points
acupuncture: acupuncture on GV26 and 12 Well points | 7 |
| Laser Acupuncture laser acupuncture on GV26 and 12 Well points
laser acupuncture: laser acupuncture on GV26 and 12 Well points | 9 |
| Control Group laser acupuncture without laser output in control group.
control: sham laser acupuncture | 6 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Acupuncture | Laser Acupuncture | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 40.29 years STANDARD_DEVIATION 17.14 | 49.11 years STANDARD_DEVIATION 16.86 | 47.17 years STANDARD_DEVIATION 21.47 | 45.77 years STANDARD_DEVIATION 17.82 |
| Region of Enrollment Taiwan | 7 participants | 9 participants | 6 participants | 22 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 4 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 9 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 9 | 0 / 6 |
Outcome results
Primary
Glasgow Coma Scale (GCS)
Eye response (E) There are four grades starting with the most severe: 1. No eye opening 2. Eye opening in response to pain stimulus. 3. Eye opening to speech. 4. Eyes opening spontaneously Verbal response (V) There are five grades starting with the most severe: 1. No verbal response 2. Incomprehensible sounds. 3. Inappropriate words. 4. Confused. 5. Oriented. Motor response (M) There are six grades: 1. No motor response 2. Decerebrate posturing accentuated by pain 3. Decorticate posturing accentuated by pain 4. Withdrawal from pain 5. Localizes to pain 6. Obeys commands The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome.
Time frame: 6 weeks
Population: The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The GCS was measured before and after treatment during hospitalization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Glasgow Coma Scale (GCS) | 3.14 units on a scale | Standard Deviation 1.46 |
| Laser Acupuncture | Glasgow Coma Scale (GCS) | 3.11 units on a scale | Standard Deviation 3.02 |
| Control Group | Glasgow Coma Scale (GCS) | 4.67 units on a scale | Standard Deviation 2.73 |
Secondary
Muscle Power (MP)
Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement 1. Flicker of movement only 2. Movement possible when assisted by gravity or gravity is eliminated 3. Movement possible against gravity but without imposed resistance 4. Weak movement possible against gravity 5. Normal movement against gravity and against imposed resistance 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.
Time frame: 6 weeks
Population: The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The MP was measured before and after treatment during hospitalization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Muscle Power (MP) | 4.29 units on a scale | Standard Deviation 4.46 |
| Laser Acupuncture | Muscle Power (MP) | 4.33 units on a scale | Standard Deviation 3.39 |
| Control Group | Muscle Power (MP) | 2.83 units on a scale | Standard Deviation 3.49 |